Journal ArticleDOI
Aripiprazole for the treatment of pediatric bipolar I disorder: a 30‐week, randomized, placebo‐controlled study
Robert L. Findling,Christoph U. Correll,Margaretta Nyilas,Robert A. Forbes,Robert D. McQuade,N. Jin,Svetlana Ivanova,Raymond Mankoski,William H. Carson,Gabrielle A. Carlson +9 more
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TLDR
Evaluated the long‐term efficacy, safety, and tolerability of aripiprazole in pediatric subjects with bipolar I disorder and found it to be safe and effective.Abstract:
Objective: To evaluate the long-term efficacy, safety, and tolerability of aripiprazole in pediatric subjects with bipolar I disorder.
Methods: A randomized, double-blind, 30-week, placebo-controlled study of aripiprazole (10 or 30 mg/day) in youths (10–17 years) with bipolar I disorder (manic or mixed) ± psychotic features (n = 296) was performed. After four weeks, acute treatment completers continued receiving ≤26 weeks of double-blind treatment (n = 210). The primary outcome was Young Mania Rating Scale (YMRS) total score change.
Results: Of the 210 subjects who entered the 26-week extension phase, 32.4% completed the study (45.3% for aripiprazole 10 mg/day, 31.0% for aripiprazole 30 mg/day, and 18.8% for placebo). Both aripiprazole doses demonstrated significantly (p < 0.001) greater improvements in YMRS total score at endpoint compared with placebo in protocol-specified last observation carried forward analyses, but not in observed case or mixed-model repeated measures at week 30. Overall time to all-cause discontinuation was longer for aripiprazole 10 mg/day (15.6 weeks) and aripiprazole 30 mg/day (9.5 weeks) compared with placebo (5.3 weeks; both p < 0.05 versus placebo). Both aripiprazole doses were significantly superior to placebo regarding response rates, Children’s Global Assessment of Functioning and Clinical Global Impressions-Bipolar severity of overall and mania scores at endpoint in all analyses. Commonly reported adverse events included headache, somnolence, and extrapyramidal disorder.
Conclusions: Aripiprazole 10 mg/day and 30 mg/day were superior to placebo and generally well tolerated in pediatric subjects with bipolar I disorder up to 30 weeks. Despite the benefits of treatment, completion rates were low in all treatment arms.read more
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A rating scale for drug-induced akathisia
TL;DR: A rating scale for drug-induced akathisia has been derived that incorporates diagnostic criteria for pseudoakathisio, and mild, moderate, and severe akath isia, and there is an item for rating global severity.
Journal ArticleDOI
Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder
Lakshmi N. Yatham,Sidney H. Kennedy,Sagar V. Parikh,Ayal Schaffer,David J. Bond,Benicio N. Frey,Verinder Sharma,Benjamin I. Goldstein,Soham Rej,Serge Beaulieu,Martin Alda,Glenda MacQueen,Roumen Milev,Arun V. Ravindran,Claire O'Donovan,Diane McIntosh,Raymond W. Lam,Gustavo Vazquez,Flávio Kapczinski,Roger S. McIntyre,Jan Marie Kozicky,Shigenobu Kanba,Beny Lafer,Trisha Suppes,Joseph R. Calabrese,Eduard Vieta,Gin S Malhi,Robert M. Post,Michael Berk +28 more
TL;DR: These 2018 CANMAT and ISBD Bipolar Treatment Guidelines represent the significant advances in the field since the last full edition was published in 2005, including updates to diagnosis and management as well as new research into pharmacological and psychological treatments.
Journal ArticleDOI
The International Society for Bipolar Disorders Task Force report on pediatric bipolar disorder: Knowledge to date and directions for future research.
Benjamin I. Goldstein,Benjamin I. Goldstein,Boris Birmaher,Gabrielle A. Carlson,Melissa P. DelBello,Robert L. Findling,Mary A. Fristad,Robert A. Kowatch,David J. Miklowitz,Fabiano G. Nery,Guillermo Perez-Algorta,Anna Van Meter,Cristian Patrick Zeni,Christoph U. Correll,Hyo-Won Kim,Janet Wozniak,Kiki D. Chang,Manon H.J. Hillegers,Eric A. Youngstrom +18 more
TL;DR: The overall body of evidence supports the position that perceptions about marked international (US vs elsewhere) and developmental (pediatric vs adult) differences have been overstated, although additional research on these topics is warranted.
Journal ArticleDOI
Brexpiprazole and cariprazine: distinguishing two new atypical antipsychotics from the original dopamine stabilizer aripiprazole
TL;DR: Each drug varies in affinity for both the D2R and a diverse group of 5-HTRs, generating a distinct profile of clinical indications and adverse effects for each.
Journal ArticleDOI
Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents.
Floyd R. Sallee,Eva Kohegyi,Joan Zhao,Robert D. McQuade,Kevin Cox,Raymond Sanchez,Alet van Beek,Margaretta Nyilas,William H. Carson,Roger Kurlan +9 more
TL;DR: This study indicates that oral aripiprazole is a safe and effective treatment for tics in children and adolescents with TD.
References
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Journal ArticleDOI
Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): Initial Reliability and Validity Data
Joan Kaufman,Boris Birmaher,David A. Brent,Uma Rao,Uma Rao,Cynthia Flynn,Cynthia Flynn,Paula Moreci,Douglas E. Williamson,Neal D. Ryan +9 more
TL;DR: Results suggest the K-SADS-PL generates reliable and valid child psychiatric diagnoses.
Journal ArticleDOI
A rating scale for mania: reliability, validity and sensitivity.
TL;DR: The MRS score correlated highly with an independent global rating, and with scores of two other mania rating scales administered concurrently, and also correlated with the number of days of subsequent stay in hospital.
Journal ArticleDOI
A Children's Global Assessment Scale (CGAS)
David Shaffer,Madelyn S. Gould,James Robert Brašić,Paul Ambrosini,Prudence W. Fisher,Hector R. Bird,Satwant Aluwahlia +6 more
TL;DR: The findings indicate that the CGAS can be a useful measure of overall severity of disturbance and is recommended to both clinicians and researchers as a complement to syndrome-specific scales.
Journal ArticleDOI
A rating scale for extrapyramidal side effects
TL;DR: A modification of an earlier rating scale for extrapyramidal system disturbance is described, and evidence for the validity and reliability of the scale is presented.
Journal Article
A rating scale for drug-induced akathisia
TL;DR: A rating scale for drug-induced akathisia has been derived that incorporates diagnostic criteria for pseudoakathisio, and mild, moderate, and severe akath isia, and there is an item for rating global severity.