Showing papers on "Escitalopram published in 2005"

Newer antidepressants in pregnancy and rates of major malformations: a meta‐analysis of prospective comparative studies

Abstract: Background A substantial number of women of childbearing age suffer from depression. Despite this, relatively little is known about the safety of antidepressant use during pregnancy. Purpose We conducted a meta-analysis of prospective comparative cohort studies to quantify the relationship between maternal exposure to the newer antidepressants and major malformations. Methods We searched Medline, Embase and Reprotox from 1996 to the present for studies comparing outcomes in first trimester exposures to citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, reboxetine, venlafaxine, nefazodone, trazodone, mirtazapine and bupropion to those of non-exposed mothers. Data were combined using a random effects model; heterogeneity was tested with χ2, and publication bias with a funnel plot and the Begg–Mazumdar statistic. Results Twenty-two studies were identified, 15 were rejected (4 reviews, 4 without comparison groups, 2 third trimester exposures, 2 retrospective database studies, 2 case reports and 1 duplicate); 7 studies (n = 1774) met inclusion criteria. Effects were not heterogeneous (χ2 = 2.04, p = 0.92); funnel plot and test (τ = −0.24, p = 0.45) indicated no publication bias. The summary relative risk was 1.01 (95%CI: 0.57–1.80). Conclusions As a group, the newer antidepressants are not associated with an increased risk of major malformations above the baseline of 1–3% in the population. Copyright © 2005 John Wiley & Sons, Ltd.

Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder.

Abstract: Pre-clinical studies, active-control clinical trials and meta-analyses indicate that escitalopram (S-citalopram) might be more effective than citalopram, the racemic mixture of S- and R-citalopram. The present study aimed to confirm the superior efficacy of escitalopram over citalopram. A double-blind, randomized clinical trial was performed in which general practitioners and psychiatrists compared fixed doses of escitalopram (20 mg/day) with citalopram (40 mg/day) over 8 weeks in outpatients with major depressive disorder (MDD) [baseline Montgomery-Asberg Depression Rating Scale (MADRS) score > or =30]. Primary efficacy parameter was change from baseline to last assessment in the MADRS total score. Out of 138 (aged 44.1+/-10.9 years; initial MADRS score 36.3+/-4.8) and 142 (aged 46.2+/-11.1 years; initial MADRS score 35.7+/-4.4) evaluable patients who were randomized to escitalopram and citalopram, respectively, six and 15 withdrew prematurely (P=0.05). The MADRS score decreased more in the escitalopram than in the citalopram arm (-22.4+/-12.9 versus -20.3+/-12.7; P<0.05). There were more treatment responders with escitalopram (76.1%) than with citalopram (61.3%, P<0.01). Adjusted remitter rates were 56.1% and 43.6%, respectively (P<0.05). Tolerability was similar in both groups. This randomized double-blind trial confirms that escitalopram has a superior effect to citalopram in MDD.

The Safety of Newer Antidepressants in Pregnancy and Breastfeeding

Abstract: The pregnancy and postpartum periods are considered to be relatively high risk times for depressive episodes in women, particularly for those with pre-existing psychiatric illnesses. Therefore, it may be necessary to start or continue the pharmacological treatment of depression during these two timeframes. Hence, the aim of this review is to examine the effects on the fetus and infant of exposure, through the placenta and maternal milk, to the following drugs: fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram, mirtazapine, venlafaxine, reboxetine and bupropion. The teratogenic risks, perinatal toxicity and effects on the neurobehavioural development of newborns associated with exposure through the placenta or maternal milk to these medications need to be carefully assessed before starting psychopharmacological treatment in pregnant or lactating women. In spite of the limitations of some of the studies reviewed, the older selective serotonin-reuptake inhibitors (SSRIs) [as we await further data regarding escitalopram] and venlafaxine seem to be devoid of teratogenic risks. By contrast, the data concerning possible consequences related to exposure to SSRIs via the placenta and breastmilk on neonatal adaptation and long-term neurocognitive infant's development are still controversial. Nevertheless, a number of reports have shown that an association between placental exposure to SSRIs and adverse but self-limiting effects on neonatal adaptation may exist. In addition, the information on both teratogenic and functional teratogenic risks associated with exposure to bupropion, mirtazapine and reboxetine is incomplete or absent; at present, these compounds should not be used as first-line agents in the pharmacological treatment of depression in pregnancy and breastfeeding. Untreated depression is not without its own risks since mothers affected by depression have a negative impact on the emotional development of their children and major depression, especially when complicated by a delusional component, may lead to the mother attempting suicide and infanticide. Consequently, clinicians need to help mothers weigh the risks of prenatal exposure to drugs for their babies against the potential risks of untreated depression and abrupt discontinuation of pharmacological treatment. Given these situations, we suggest that choosing to administer psychopharmacological treatment in pregnant or breastfeeding women with depression will result primarily from a careful evaluation of their psychopathological condition; currently, the degree of severity of maternal disease appears to represent the most relevant parameter to take this clinical decision.

Escitalopram in the treatment of social anxiety disorder: randomised, placebo-controlled, flexible-dosage study.

Abstract: Background Selective serotonin reuptake inhibitors are effective in the treatment of social anxiety disorder and are currently regarded as the pharmacotherapy of choice. Aims To investigate the efficacy and tolerability of escitalopram in the treatment of generalised social anxiety disorder. Method Patients with generalised social anxiety disorder were randomised to receive placebo ( n =177) or 10-20 mg escitalopram ( n =181) in a 12-week, double-blind trial. The primary outcome measure was the mean change from baseline to last assessment in the Liebowitz Social Anxiety Scale (LSAS) total score. Results The study showed a statistically superior therapeutic effect for escitalopram compared with placebo on the LSAS total score ( P =0.005). There were significantly more responders to treatment for escitalopram than for placebo (54% v . 39%; P <0.01). The clinical relevance of these findings was supported by significant reduction in the work and social components of the Sheehan Disability Scale and by the good tolerability of escitalopram treatment. Conclusions Escitalopram was efficacious and well tolerated in the treatment of generalised social anxiety disorder.

Escitalopram in the treatment of depressed elderly patients.

Abstract: Objective Management of depression in elderly patients presents a significant medical challenge, and there is a need for further clinical trials. The authors examined the efficacy and tolerability of escitalopram and fluoxetine versus placebo in the treatment of elderly patients with major depressive disorder (MDD). Methods This was an 8-week, randomized, double-blind comparison of the efficacy and tolerability of escitalopram (10 mg/day) and fluoxetine (20 mg/day), to placebo in elderly patients with MDD. The prospectively defined primary efficacy parameter was the change from baseline in mean Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpoint, using last observation carried forward. Results The intent-to-treat set comprised 517 patients; the escitalopram group included 173 patients; fluoxetine, 164 patients; and placebo, 180 patients. Mean age was 75 years, with a range of 65 to 93. Formally, this was a “failed study” (i.e., neither active treatment was superior to placebo), and the efficacy results should, therefore, be interpreted with caution. On the basis of the primary efficacy parameter, fluoxetine showed significantly lower efficacy than both escitalopram and placebo, which were not significantly different from each other. Rates of withdrawal because of adverse events/lack of efficacy were: placebo (2.8%/4.4%, respectively), escitalopram (9.8%/1.7%, respectively), and fluoxetine (12.2%/1.8%, respectively). No single adverse event occurred at an incidence ≥10% in escitalopram-treated patients. Conclusions Both escitalopram and fluoxetine were well tolerated by elderly patients with MDD. Neither demonstrated superior efficacy on primary endpoint versus placebo.

Evidence-based pharmacotherapy of generalized anxiety disorder

Abstract: Generalized Anxiety Disorder (GAD) is a common and often disabling disorder. This paper reviews the pharmacological treatment of GAD, based on the findings of published meta-analyses and randomized placebo-controlled studies. In doing so, it aims to address three fundamental questions: What is the first-line treatment for GAD? How long should treatment continue? What is the best intervention in patients who do not respond to first-line and second-line treatments? Due to their efficacy in GAD and comorbid anxiety and depressive disorders, their tolerability and safety, certain selective serotonin re-uptake inhibitors (escitalopram, paroxetine, sertraline) should be considered the first-line treatment for most patients, although the serotonin-noradrenaline re-uptake inhibitor venlafaxine is a reasonable alternative. Little is known about the optimal length of therapy after response to acute treatment but relapse-prevention studies with paroxetine suggest that continuation treatment should last for at least 6 months. The management of patients who do not respond to first-line treatment is uncertain, but some patients may benefit from certain tricyclic antidepressants, buspirone, or pregabalin.

Generalised anxiety disorder in elderly patients : epidemiology, diagnosis and treatment options

Abstract: Generalised anxiety disorder (GAD) is characterised by at least 6 months of excessive uncontrollable worry accompanied by symptoms of motor tension and vigilance and scanning. As with other anxiety disorders, GAD is less prevalent in older adults than younger adults. GAD has a high level of comorbidity with other psychiatric disorders and this has a bearing on estimates of its prevalence. GAD that is comorbid with another psychiatric disorder has a period prevalence of approximately 4% in community-dwelling older people. On the other hand, 'pure' GAD is less common, with a period prevalence of approximately 1%. Pure GAD in late life is a fairly even mix of chronic cases that began earlier in life and cases starting for the first time in later life. The most frequent and consistent finding regarding late-life generalised anxiety is its high level of comorbidity with major depression. There are few longitudinal data pertaining to the temporal association of generalised anxiety and major depression in late life, but the data that do exist suggest that the anxiety is frequently symptomatic of the depression. If generalised anxiety occurs exclusively during episodes of major depression, a separate diagnosis of GAD is not warranted. Cognitive behaviour therapy (CBT) is the most frequently studied psychological treatment for GAD. Although CBT is more effective than a wait-list control condition, it is not more effective than nondirective therapies in late-life GAD. Furthermore, a standard course of CBT appears to be less efficacious for GAD in older adults than younger adults. Further research is needed to develop more efficacious and specific forms of psychotherapy for late-life GAD. The three classes of medications that are most commonly used for GAD are: (i) antidepressants; (ii) benzodiazepines; and (iii) buspirone. Antidepressant medication is the pharmacological treatment of choice for most older adults with generalised anxiety. When generalised anxiety is secondary to an episode of major depression, the selection of an antidepressant is guided by the same principles that apply to treatment of nonanxious depression. Antidepressant medication is also effective for GAD in the absence of an episode of major depression. In this situation, citalopram and venlafaxine have been found to be efficacious in older people. Data from studies of mixed-aged patients suggest that escitalopram, paroxetine and trazodone may also be beneficial in late-life GAD. Despite their widespread use in older persons with anxiety, benzodiazepines have a limited role in the treatment of GAD in the elderly. If a benzodiazepine is initiated, pharmacokinetic considerations favour the use of either lorazepam or oxazepam. Buspirone also has a more limited role than antidepressants in the treatment of late-life GAD.

Escitalopram: a review of its use in the management of major depressive disorder

Abstract: Escitalopram (Cipralex, Lexapro), the active S-enantiomer of the racemic selective serotonin reuptake inhibitor (SSRI) citalopram (RS-citalopram), is a highly selective inhibitor of the serotonin transporter protein. It possesses a rapid onset of antidepressant activity, and is an effective and generally well tolerated treatment for moderate-to-severe major depressive disorder (MDD). Pooled analyses from an extensive clinical trial database suggest that escitalopram is consistently more effective than citalopram in moderate-to-severe MDD. Preliminary studies suggest that escitalopram is as effective as other SSRIs and the extended-release (XR) formulation of the serotonin/noradrenaline (norepinephrine) reuptake inhibitor venlafaxine, and may have cost-effectiveness and cost-utility advantages. However, additional longer-term, comparative studies evaluating specific efficacy, tolerability, health-related quality of life and economic indices would be helpful in definitively positioning escitalopram relative to these other agents in the treatment of MDD. Nevertheless, available clinical and pharmacoeconomic data indicate that escitalopram is an effective first-line option in the management of patients with MDD.

A 24-week randomized, double-blind, placebo-controlled study of escitalopram for the prevention of generalized social anxiety disorder.

Abstract: OBJECTIVE Escitalopram has proven efficacy in the short-term treatment of generalized social anxiety disorder (SAD). The present relapse prevention study investigated relapse rates during a 24-week, randomized, double-blind, placebo-controlled period in patients with generalized SAD who had responded to 12-week open-label treatment with escitalopram. METHOD A total of 517 patients with a primary diagnosis of generalized SAD (per DSM-IV criteria) and a Liebowitz Social Anxiety Scale (LSAS) total score of > or = 70 received 12 weeks of open-label treatment with flexible doses (10-20 mg/day) of escitalopram. Of these patients, 371 responded (Clinical Global Impressions-Improvement scale [CGI-I] score of 1 or 2) and were randomly assigned to 24 weeks of double-blind treatment with escitalo-pram (10 or 20 mg/day) (N = 190) or placebo (N = 181), continuing with the dose level administered at the end of the open-label period. Relapse was defined as either an increase in LSAS total score of > or = 10 or withdrawal due to lack of efficacy, as judged by the investigator. The study was conducted from January 2001 to June 2002. RESULTS Survival analysis of relapse and time to relapse showed a significant advantage for escitalopram compared to placebo (log-rank test: p < .001). The risk of relapse was 2.8 times higher for placebo-treated patients than for escitalopram-treated patients (p < .001), resulting in significantly fewer escitalopram-treated patients relapsing (22% vs. 50%), at both doses. Escitalopram was well tolerated during double-blind treatment of generalized SAD, and only 2.6% of the escitalopram-treated patients withdrew because of adverse events. The overall discontinuation rate, excluding relapses, was 13.2% for patients treated with escitalopram and 8.3% for patients treated with placebo. CONCLUSION Escitalopram was effective and well tolerated in the long-term treatment of generalized SAD.

A Double-Blind Comparison of Escitalopram and Paroxetine in the Long-Term Treatment of Generalized Anxiety Disorder

Abstract: Background. This study compared the efficacy and tolerability of escitalopram, a newer SSRI, with paroxetine in the treatment of generalized anxiety disorder (GAD).Methods. Patients with DSM-IV-defined GAD were randomized to receive 24 weeks of double-blind flexible-dose treatment with either escitalopram (10–20 mg/day) or paroxetine (20–50 mg/day), followed by a 2-week, double-blind, down-titration period. Mean change from baseline to endpoint (LOCF) in Hamilton Anxiety Scale (HAMA) scores was the primary efficacy variable.Results. Mean baseline HAMA scores for the escitalopram (N=60) and paroxetine (N=61) groups were 23.7 and 23.4, respectively. After 24 weeks of treatment, mean changes in HAMA scores were −15.3 and −13.3 for escitalopram and paroxetine, respectively (p=0.13). Significantly fewer patients withdrew from escitalopram than paroxetine treatment due to adverse events (6.6% vs. 22.6%; p=0.02). The frequency of treatment-emergent adverse events was higher with paroxetine vs. escitalopram: over...

Actual driving performance and psychomotor function in healthy subjects after acute and subchronic treatment with escitalopram, mirtazapine, and placebo: a crossover trial.

Abstract: OBJECTIVE: The effects of escitalopram 10 to 20 mg/day and mirtazapine 30 to 45 mg/day on actual driving and psychomotor performance of 18 healthy subjects were determined in a randomized, double-blind, placebo-controlled, multiple-dose, 3-way crossover trial. METHOD: Each treatment period lasted for 15 days and was separated from the next period by a washout period of at least 13 days. Subjects received an evening dose of escitalopram 10 mg, mirtazapine 30 mg, or placebo from days 1 to 7 and an evening dose of escitalopram 20 mg, mirtazapine 45 mg, or placebo from days 8 to 15. On days 2, 9, and 16, reflecting acute period, dose increase, and steady state, respectively, the Road Tracking Test was performed. The main parameter was standard deviation of lateral position. Psychomotor performance was also assessed on days 2, 9, and 16 by laboratory computer tasks. Subjective sleep quality was measured with the Groninger Sleep Quality Scale, and mood was measured by visual analogue scales. RESULTS: Treatment differences were apparent during the acute treatment period, in which subjects treated with mirtazapine 30 mg performed less well on the driving test as compared to placebo. The Divided Attention Task results also revealed a significant increase in tracking error after a single dose of mirtazapine 30 mg as compared to placebo. Mirtazapine decreased feelings of alertness and contentedness. Mirtazapine did not affect performance on days 9 and 16 of treatment. Escitalopram did not affect driving, psychomotor performance, or subjective mood throughout treatment. CONCLUSION: Driving performance, as well as psychomotor functioning, was not affected by escitalopram treatment in healthy subjects. Driving performance was significantly impaired after ingestion of mirtazapine 30 mg during the acute treatment period.

An open-label trial of escitalopram in pervasive developmental disorders.

Abstract: Objective To assess the effect of escitalopram in the treatment of pervasive developmental disorders (PDDs). Method This 10-week study had a forced titration, open-label design. Twenty-eight subjects (mean age 125.1 ± 33.5 months) with a PDD received escitalopram at a dose that increased weekly to a maximum dose of 20 mg as tolerated. The Aberrant Behavior Checklist-Community Version (ABC-CV) and the Clinical Global Impression scale (CGI) were used to assess outcome. Results There was significant improvement in ABC-CV Irritability Subscale Scores (baseline mean 20.5 ± 5.9 to final mean 10.9 ± 7.2; p ≤ .001) and in the other ABC-CV Subscales. Improvement on Clinical Global Improvement Scale severity rating was also significant (baseline mean 5.2 ± 1.0 to final mean 4.6 ± 1.2; p ≤ .001). Twenty-five percent of the subjects responded at a dose less than 10 mg and did not tolerate the 10-mg dose, and an additional 36% responded at a dose greater than or equal to 10 mg. Final dose was unrelated to weight and only weakly correlated with age. Conclusions This open-label study found escitalopram to be useful in treating some difficulties common in PDDs. A wide variability in dose was found that could not be accounted for by weight and only partially by age. The study provides information useful for the design of double-blind, placebo-controlled studies of escitalopram in PDDs.

Does rTMS Hasten the Response to Escitalopram, Sertraline, or Venlafaxine in Patients With Major Depressive Disorder? A Double-Blind, Randomized, Sham-Controlled Trial

Abstract: Background/objective Repetitive transcranial magnetic stimulation (rTMS) has been mainly studied as adjunctive treatment for drug-resistant patients. We assessed the effectiveness of rTMS started concomitantly with antidepressant medications in non-drug-resistant major depressive disorder patients. We also evaluated if, among the 3 antidepressants administered, one had a better synergy with rTMS. Method In this 5-week, double-blind, randomized, sham-controlled study, we recruited 99 inpatients suffering from a major depressive episode (DSM-IV criteria). They were randomly assigned to receive venlafaxine, sertraline, or escitalopram in combination with a 2-week period of sham or active 15-Hz rTMS on the left dorso-lateral prefrontal cortex. Data were gathered from February 2004 to June 2005. Results The active rTMS group showed a significantly faster reduction in Hamilton Rating Scale for Depression (HAM-D) scores compared with the sham group (p = .0029). The response and remission rates were significantly greater in the active rTMS group after the stimulation period (p = .002 and p = .003, respectively), but not at the endpoint. We found no significant difference in HAM-D score reduction among the 3 drugs administered, either in the active or in the sham group. Conclusion These findings support the efficacy of rTMS in hastening the response to antidepressant drugs in patients with major depressive disorder. The effect of rTMS seems to be unaffected by the specific concomitantly administered drug.

A randomized, double-blind, 24-week study of escitalopram (10 mg/day) versus citalopram (20 mg/day) in primary care patients with major depressive disorder.

Abstract: Objective: A randomized, double-blind, 24‐week fixed-dose study comparing the efficacy and safety of escitalopram to that of citalopram was conducted in primary care patients with moderate to severe major depressive disorder (MDD).Research design and methods: This was a randomized, double-blind, 24‐week fixed-dose study. Patients were randomly assigned to treatment with escitalopram 10 mg/day (n = 175) or citalopram 20 mg/day (n = 182). Clinical response was evaluated using the Montgomery–Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity (CGI‐S) scale. The prospectively defined primary parameter of antidepressant efficacy was the change from baseline in the mean MADRS total score during the 24 weeks of double-blind treatment, using a repeated measures analysis of variance to compare the treatment groups over all assessment points simultaneously.Results: Based on the primary parameter, escitalopram was at least as efficacious as citalopram. Based on the prospectively de...

Efficacy of escitalopram in patients with severe depression: a pooled analysis.

Abstract: Summary Escitalopram is an effective, well-tolerated treatment for major depressive disorder in both primary and specialist settings. This analysis compared the efficacy of escitalopram with citalopram in the treatment of patients with severe depression [defined as a score of ≥30 Montgomery–Asberg Depression Rating Scale (MADRS)]. Data from three clinical trials were used for this pooled analysis. A total of 506 severely depressed patients were included (169 received escitalopram, 171 citalopram and 166 placebo). Mean change from baseline in MADRS total scores (primary efficacy parameter) was significantly higher in the escitalopram-treated group compared with the citalopram-treated group (p = 0.003). There was a significant difference in response between escitalopram and citalopram (56 vs. 41%, respectively, p = 0.007). Results from secondary efficacy parameters (Hamilton rating for depression and Clinical Global Impression of Improvement and Severity scales) were consistent with previous results. The benefits in severe depression of escitalopram vs. citalopram were so demonstrated.

Evaluation of the cost effectiveness of escitalopram versus venlafaxine XR in major depressive disorder.

Abstract: Aim: To assess the relative cost effectiveness of escitalopram compared with venlafaxine XR in patients with major depressive disorder (MDD). Methods: An economic evaluation was conducted alongside a double-blind, multinational, randomised clinical trial and examined the costs and quality of life of 251 patients taking escitalopram versus venlafaxine. Outpatients fulfilling criteria for MDD were randomised to receive oral escitalopram 10–20 mg/day or venlafaxine 75–150 mg/day for 8 weeks. Patient-reported outcomes (EuroQOL questionnaire, Quality of Life Depression Scale), use of medical services and absence from work (relating to the previous 3 months) were recorded at baseline, with repeated measurements at week 8. Unit costs in year values were applied to the resource utilisation data. A cost-effectiveness analysis was performed using the EuroQOL score as the effectiveness measure. The perspective was that of the healthcare payer, with a societal perspective considered in a sensitivity analysis. Results: Statistically significant improvements in patient-reported outcomes (vs baseline) were observed in both groups after 8 weeks’ treatment. Patients treated with escitalopram tended to report fewer problems on the EuroQOL dimensions than venlafaxine recipients. Mean per-patient costs in euros (€, year 2003 values) for the escitalopram group, compared with the venlafaxine group, were 32% lower (€110 vs €161) from a healthcare perspective, although this was not a statistically significant difference. Differences were related to lower drug acquisition costs and fewer hospitalisations for escitalopram than venlafaxine recipients. A multivariate model adjusting for baseline characteristics showed that escitalopram reduced direct costs compared with venlafaxine (p = 0.007). Bootstrapped distributions of the incremental cost-effectiveness ratios also showed similar effectiveness but lower costs for escitalopram compared with venlafaxine. Inclusion of indirect costs led to similar results. Conclusion: This prospective economic analysis suggests that escitalopram has similar effectiveness to venlafaxine in the treatment of MDD, but may be associated with lower healthcare costs. These findings are consistent with previously published economic evaluations.

Guideline Watch: Practice Guideline for the Treatment of Patients With Major Depressive Disorder, 2nd Edition

Abstract: Since the publication in 2000 of APA’s Practice Guideline for the Treatment of Patients With Major Depressive Disorder (2nd Edition) (1), two important safety concerns have emerged (hepatotoxicity with nefazodone, and suicide risk and antidepressants), and two new antidepressants have been approved for use (escitalopram and duloxetine). This watch describes these developments as well as evidence that has accrued since 2000 in other areas related to the treatment of major depressive disorder.

Pharmacotherapy for major depression in children and adolescents.

Abstract: Major depression is a serious illness in children which adversely effects their social, academic, and emotional development. It is essential to identify safe and effective medication for the treatment of this disorder in youths. Only some selective serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline) have demonstrated superiority to placebo on primary outcome measures in acute controlled treatment trials. This article will review acute efficacy studies as well as long-term studies of antidepressants for the treatment of childhood depression. Treatment recommendations are discussed and the issue of suicidality and antidepressants are addressed.

Escitalopram in the treatment of generalized anxiety disorder

Abstract: The selective serotonin reuptake inhibitor escitalopram is the active enantiomer of citalopram and has proven efficacy in the treatment of major depression, panic disorder and social phobia. Accumulating data indicate that it is also efficacious in the treatment of patients with generalized anxiety disorder. This drug profile summarizes the current evidence-base for the treatment of generalized anxiety disorder, describes the findings of a series of randomized placebo-controlled and comparator-controlled trials of escitalopram, examines the strengths and weaknesses of current treatment approaches and considers potential new therapies for the treatment of this common, chronic and impairing anxiety disorder. In summary, escitalopram is effective and well tolerated in both the short- and long-term treatment of generalized anxiety disorder, and has advantages over benzodiazepines and the selective serotonin reuptake inhibitor paroxetine.

Escitalopram and suicidality in adult depression and anxiety.

Abstract: The escitalopram clinical trial database, consisting of all placebo-controlled and relapse prevention trials within major depressive disorder (MDD) and anxiety disorders, was analysed for specific adverse events indicative of suicidal behaviour (fatal suicide, non-fatal self-harm or suicidal thoughts) in relation to treatment. The number of events was low, with no fatal suicides in the first 2 weeks of treatment. There was one fatal suicide during the full treatment period on placebo (incidence 0.1%; rate 0.003), and none on escitalopram. None of these figures were significantly different between escitalopram (n=2277) and placebo (n=1814) patients. There was no indication that escitalopram provokes suicidal behaviour compared to placebo in either MDD or anxiety disorders. Based on efficacy ratings (Montgomery-Asberg Depression Rating Scale, item 10), escitalopram was more efficacious versus placebo in lowering suicidal thoughts from weeks 1 through 8 in the treatment of patients with MDD.

A preliminary study of luteal phase versus symptom-onset dosing with escitalopram for premenstrual dysphoric disorder.

Abstract: Objective This preliminary study compared the efficacy and tolerability of escitalopram administered at symptom onset or throughout the luteal phase in premenstrual dysphoric disorder (PMDD). Method Twenty-seven women meeting DSM-IV criteria for PMDD were randomly assigned in a double-blind manner to luteal phase (N = 13) or symptom-onset (N = 14) dosing of escitalopram (10-20 mg/day) for 3 consecutive menstrual cycles. Participants were enrolled from November 2002 to July 2003, and data collection was completed in December 2003. Symptoms were assessed using the 17-item Penn Daily Symptom Report (DSR), the Clinical Global Impressions-Improvement scale, the Hamilton Rating Scale for Depression, and the Sheehan Disability Scale. Scores were compared using repeated measures analysis of covariance and t statistics. Results Luteal phase and symptom-onset groups received escitalopram for a mean of 13.5 and 6.0 days, respectively (mean +/- SD dose = 15.2 +/- 5.1 mg/day at the third treatment cycle). Total premenstrual DSR scores significantly improved from baseline (p = .003), with a 57% decrease in the luteal phase group and a 51% decrease in the symptom-onset group. Clinical improvement (DSR score decrease > or = 50% from baseline) was reported by 11 of 13 patients in the luteal phase group and 9 of 14 patients in the symptom-onset group. Symptom severity differentiated the response in the symptom-onset group, with those having more severe symptoms less likely to respond. Symptom severity did not differentiate treatment response to luteal phase dosing. Escitalopram was well tolerated. Adverse events were mild and transient, with only 2 patients discontinuing due to adverse events related to the medication. Conclusion Premenstrual dysphoric disorder improved significantly with either luteal phase or symptom-onset dosing of escitalopram. Women with more severe PMDD may respond better to luteal phase dosing than symptom-onset dosing.

Safety and efficacy of escitalopram in the long-term treatment of generalized anxiety disorder.

Abstract: INTRODUCTION Generalized anxiety disorder (GAD) is a chronic disorder that requires long-term treatment. Escitalopram has previously been shown to be effective and well tolerated in the acute treatment of GAD. METHOD Three 8-week, double-blind, placebo-controlled trials of nearly identical design were conducted of escitalopram in moderate-to-severe GAD (DSM-IV criteria). Patients completing these trials were given the option of entering a 24-week, open-label, flexible-dose trial of escitalopram (10-20 mg/day). Data were collected from September 20, 2000, to August 15, 2002. RESULTS Two hundred ninety-nine (56.8%) of 526 patients completed 24 weeks of open-label treatment. The mean Hamilton Rating Scale for Anxiety (HAM-A) score at baseline of open-label treatment was 13.1. Long-term escitalopram treatment led to continuing improvement on all anxiety and quality-of-life (QOL) scores. Of those completing 24 weeks of treatment, 92.0% were responders (Clinical Global Impressions-Improvement scale score < or = 2), and the mean HAM-A score in the completed analysis was 6.9; using the last observation carried forward (LOCF), 75.9% were responders, and the mean HAM-A score in the LOCF analysis was 9.2 at endpoint. Insufficient therapeutic response and adverse events led to withdrawal of 4.2% and 9.9% of patients, respectively. Mean increase in weight from baseline was 3.0 lb. No clinically notable changes in mean laboratory, vital sign, or electrocardiographic values were observed. CONCLUSION These results support the long-term tolerability and effectiveness of escitalopram in the treatment of GAD.

Use of Selective Serotonin-Reuptake Inhibitors in the Treatment of Depression in Adults with HIV

Abstract: OBJECTIVE:To review the safety and efficacy of selective serotonin-reuptake inhibitors (SSRIs) for the treatment of depression in adults with HIV.DATA SOURCES:We searched Pre-MEDLINE and MEDLINE (1966-May 2004) using terms including generic names of antidepressants and antiretrovirals, depression, HIV, and acquired immunodeficiency syndrome. All English-language articles were included in this review.DATA SYNTHESIS:SSRIs may be effective and better tolerated than tricyclic antidepressants in HIV-positive adults. SSRIs did not appear to affect CD4+ cell counts.CONCLUSIONS:Controlled trials comparing SSRIs are lacking; thus, it is difficult to determine whether one SSRI is more efficacious than another. It appears that most SSRIs may be used in HIV-positive adults. If drug-drug interactions are a concern, sertraline, citalopram, and possibly escitalopram may be considered.

A probabilistic cost-effectiveness analysis of escitalopram, generic citalopram and venlafaxine as a first-line treatment of major depressive disorder in the UK.

Abstract: Objectives: To determine if escitalopram is cost-effective in the UK when compared with venlafaxine and generic citalopram in primary care treatment of Major Depressive Disorder (MDD).Methods: A pre-existing cost-effectiveness model was adapted to reflect the practice in the UK. Adult patients (> 18 years) with MDD [baseline scores ≥ 18 and ≤ 40 on the Montgomery–Asberg Depression Rating Scale (MADRS)] were accepted into the decision model. Success rates were derived from a meta-analysis of RCTs and other clinical and cost data from the General Practice Research Database, published literature and expert opinion. Patients were considered to be in remission when their MADRS score was ≤ 12. Failures were referred to consultant psychiatrists for secondary care. Analytic perspectives included those of society and of the National Health Service (NHS). Indirect costs were calculated using a Human Capital approach based on the average wage.Results: Expected costs were lower (£465 vs. £544) and successes w...

Selective Serotonin-Reuptake Inhibitors in the Treatment of Premature Ejaculation

Abstract: OBJECTIVETo review the use of selective serotonin-reuptake inhibitors (SSRIs) in the treatment of premature ejaculation.DATA SOURCESArticles were retrieved through a MEDLINE search (1966–January 2004). Search terms used to identify articles included serotonin uptake inhibitors, premature ejaculation, rapid ejaculation, and sexual behavior, as well as the generic names of currently available SSRIs: fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, and escitalopram. The literature search was limited to articles published in the English language containing human subjects.STUDY SELECTION AND DATA EXTRACTIONArticles obtained through the literature search were evaluated, and randomized controlled trials were included in this review. Information from noncontrolled trials or case reports was considered for inclusion if it contributed to the completeness of this review and if it was the highest level of evidence available.DATA SYNTHESISPremature ejaculation is a commonly reported sexual difficulty. Dela...

The effect of escitalopram on sleep problems in depressed patients.

Abstract: The results from three 8-week escitalopram studies in major depressive disorder are presented with respect to efficacy and the effect on sleep quality, both in the full population and the subpopulation of patients with sleep problems at baseline. Analysis of pooled data from these randomized, double-blind, placebo-controlled, studies in which citalopram was the active reference, showed a significant improvement for escitalopram-treated patients (n = 52.0) in the Montgomery-Asberg depression rating scale (MADRS) item 4 ('reduced sleep') scores at weeks 6 and 8 compared with placebo (n=398; p or = 4; n = 254) at baseline showed a statistically significant improvement in mean MADRS item 4 scores at weeks 4, 6 and 8 compared with patients treated with placebo (n = 191; p < 0.05) or citalopram (n = 193; p < 0.01). These patients also showed a statistically significant (p < 0.05) and clinically relevant improvement in MADRS total score after escitalopram treatment compared with citalopram at weeks 1, 4, 6 and 8 (observed cases) and endpoint (-2.45; last observation carried forward [LOCF]). Statistical significance in favour of escitalopram versus placebo treatment was found at all visits, including endpoint (-4.2; LOCF).Thus, these post-hoc analyses suggest that escitalopram has a significant beneficial effect compared with placebo or citalopram in reducing sleep disturbance in patients suffering from major depressive disorder. The effect of escitalopram in improving 'reduced sleep' scores was clearly seen in patients with more severe sleep disturbance at baseline. A further prospective study is needed to establish this useful clinical effect in insomniac depressives.