Psychotropic drug

About: Psychotropic drug is a research topic. Over the lifetime, 2309 publications have been published within this topic receiving 54070 citations.

Number needed to harm: its limitations in psychotropic drug safety research.

Abstract: Commonly used statistical measures to quantify the likelihood of an adverse drug event (ADE) from clinical trials include risk ratio; odds ratio; and number needed to harm (NNH), the reciprocal of absolute risk. This critical review focused on NNH, specifically on its limitations in controlled trials with psychotropic medication. Data for this evaluation were obtained primarily from articles in MEDLINE from 1988 to 2012. Limitations of NNH were found to include the following: a) arbitrary binary cutoffs for continuous measures, b) limited use of confidence intervals, c) limited adjustments for potential baseline confounders, d) limited adjustments for differences in dose and treatment duration, e) rare consideration of high attrition rates, f) variable use of the term harm, g) oversimplified single harm comparisons, h) frequent biased design and reporting, i) undue emphasis on less severe ADEs, j) application primarily to short-term clinical trials, and k) little or no generalizability in community practice. In sum, the NNH metric supplies very limited information on the risks of psychotropic medication. Postmarketing surveillance of community treatment populations using case-control methodology provides far more useful data on serious ADEs.

Nocebo effects and psychotropic drug action - an update.

Abstract: Randomized Clinical Trials (RCTs) are useful in order to study the role of the patient’s psychosocial environment and the context in which therapies are administered on subsequent negative outcomes. The evaluation of adverse events (AEs) in the placebo group, matched with a specific psychotropic drug, provides an important perspective for understanding this phenomenon. These negative outcomes are conceptualized as ‘nocebo effects’ [1], a clinically salient yet seldom studied phenomena associated with poorer treatment outcomes and treatment discontinuation [2]. There is a need for considerable further research to investigate the nocebo effect within clinical populations, since identifying nocebo responders remains a challenge [1]. One of the populations in which it is important to study the nocebo effect, due to the associated clinical implications, is that of patients with psychiatric diseases – such as major psychotic disorders and mood disorders. Indeed, AEs affect adherence and dropout rates among patients with psychiatric disorders in RCTs [3]. To date, research into RCTs has shown that placebos cause AEs similar to those observed in the active psychotropic drug groups. The AEs reported in the placebo arms of RCTs investigating both a tricyclic antidepressant and a selective serotonin reuptake inhibitor were substantial and similar to those found in the active groups [4]. Therefore, AEs may represent an interesting perspective from which to perform a more indepth characterization of psychiatric patients who are more likely to have negative outcome expectations, even if the role of prior learning associated with active treatments – in the form of conditioning – cannot be excluded. Moreover, it has been reported that, in schizophrenic patients, the level of psychopathology, such as the severity of positive symptoms and signs of anxiety and depression, widely affected their perceptions and attribution of bodily sensations to medications [5]. Indeed, a higher level of psychiatric symptomatology makes schizophrenic patients more prone to express AEs manifested as nocebo-like-effects [6].

Quality of life and mental health in adolescent users of oral contraceptives. Results from the nationwide, representative German Health Interview and Examination Survey for Children and Adolescents (KiGGS).

Abstract: Using data from the nationwide, cross-sectional KiGGS (German Health Interview and Examination Survey for Children and Adolescents) study, we investigated whether hormonal contraception in adolescents aged 15 to 17 years was linked to health-related quality of life and mental health problems. Study participants had undergone standardized recordings of blood pressure and measurements of serum 25-hydroxyvitamin D [25(OH)D]. Quality of life was assessed by self- and parent-rated KINDL-R questionnaires, whereas mental health problems were screened by means of the Strengths and Difficulties Questionnaire (SDQ). Self-rated quality of life was similar between users (n = 522) and non-users (n = 1173, 69.2%) of oral contraceptives (69.2 ± 11.2 vs. 69.2 ± 11.0, p = 0.943), as was the parent-rated version (72.9 ± 10.6 vs. 72.9 ± 10.5, p = 0.985). Likewise, no significant differences were observed between the two groups with respect to both self- (10.9 ± 4.4 vs. 10.8 ± 4.6, p = 0.732) and parent-rated SDQ scores (7.2 ± 4.8 vs. 7.0 ± 4.6. p = 0.390). However, serum 25(OH)D (59.5 ± 32.9 vs. 46.1 ± 28.0 nmol/L, p < 0.001) and mean arterial blood pressure (88.2 ± 7.4 vs. 86.5 ± 7.7 mmHg, p < 0.001) were significantly higher in users than in non-users. There was a trend towards a higher rate of psychotropic drug prescription in participants taking oral contraceptive pills as compared to those not receiving hormonal contraception (17.8% vs. 14.4%, p = 0.052). A series of linear regression models with either KINDL-R or SDQ as dependent variable confirmed that there were no associations between components of mental well-being and contraceptive drug use, irrespective of whether self- or parent-ratings were included in these models. In a large, representative sample of German adolescents, exposure to exogenous contraceptive hormones was associated with higher arterial blood pressure and serum 25(OH)D concentration, whereas hormonal contraception was not linked to health-related quality of life or mental well-being.