Aripiprazole for the treatment of pediatric bipolar I disorder: a 30‐week, randomized, placebo‐controlled study

Objective:  To evaluate the long‐term efficacy, safety, and tolerability of aripiprazole in pediatric subjects with bipolar I disorder.

[1]  M. DelBello,et al.  Efficacy and safety of extended-release quetiapine fumarate in youth with bipolar depression: an 8 week, double-blind, placebo-controlled trial. , 2014, Journal of child and adolescent psychopharmacology.

[2]  M. DelBello,et al.  Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. , 2013, Journal of child and adolescent psychopharmacology.

[3]  M. DelBello,et al.  Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder: a randomized, double-blind, placebo-controlled study. , 2009, Bipolar disorders.

[4]  Barbara Napolitano,et al.  Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents. , 2009, JAMA.

[5]  K. Chang,et al.  Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: a randomized, double-blind, placebo-controlled study. , 2009, The Journal of clinical psychiatry.

[6]  C. Correll.  Assessing and maximizing the safety and tolerability of antipsychotics used in the treatment of children and adolescents. , 2008, The Journal of clinical psychiatry.

[7]  J. Calabrese,et al.  Aripiprazole monotherapy for maintenance therapy in bipolar I disorder: a 100-week, double-blind study versus placebo. , 2007, The Journal of clinical psychiatry.

[8]  M. Tohen,et al.  Olanzapine versus placebo in the treatment of adolescents with bipolar mania. , 2007, The American journal of psychiatry.

[9]  Ruoyan Chen,et al.  Interaction of the novel antipsychotic aripiprazole with 5-HT1A and 5-HT2A receptors: functional receptor-binding and in vivo electrophysiological studies , 2007, Psychopharmacology.

[10]  B. Birmaher,et al.  Course and outcome of bipolar spectrum disorder in children and adolescents: A review of the existing literature , 2006, Development and Psychopathology.

[11]  J. Calabrese,et al.  A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder. , 2006, The Journal of clinical psychiatry.

[12]  J. Endicott,et al.  Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q): reliability and validity. , 2006, Journal of the American Academy of Child and Adolescent Psychiatry.

[13]  S. Strakowski,et al.  A double-blind randomized pilot study comparing quetiapine and divalproex for adolescent mania. , 2006, Journal of the American Academy of Child and Adolescent Psychiatry.

[14]  G. Sachs,et al.  Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study , 2006, Journal of psychopharmacology.

[15]  M. Hummer,et al.  Dropout rates in placebo-controlled and active-control clinical trials of antipsychotic drugs: a meta-analysis. , 2005, Archives of general psychiatry.

[16]  J. Biederman,et al.  Open-Label, 8-Week Trial of Olanzapine and Risperidone for the Treatment of Bipolar Disorder in Preschool-Age Children , 2005, Biological Psychiatry.

[17]  P. Janicak,et al.  Open-label prospective trial of risperidone in combination with lithium or divalproex sodium in pediatric mania. , 2004, Journal of affective disorders.

[18]  P. Keck,et al.  A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. , 2003, The American journal of psychiatry.

[19]  R. Mailman,et al.  Aripiprazole, A Novel Atypical Antipsychotic Drug with a Unique and Robust Pharmacology , 2003, Neuropsychopharmacology.

[20]  J. Calabrese,et al.  Clinical decision-making using the General Behavior Inventory in juvenile bipolarity. , 2002, Bipolar disorders.

[21]  J. Calabrese,et al.  Discriminative validity of parent report of hypomanic and depressive symptoms on the General Behavior Inventory. , 2001, Psychological assessment.

[22]  R. Reid,et al.  Assessing Culturally Different Students for Attention Deficit Hyperactivity Disorder Using Behavior Rating Scales , 1998, Journal of abnormal child psychology.

[23]  Robert M. Post,et al.  Modification of the Clinical Global Impressions (CGI) scale for use in bipolar illness (BP): the CGI-BP , 1997, Psychiatry Research.

[24]  N. Ryan,et al.  Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. , 1997, Journal of the American Academy of Child and Adolescent Psychiatry.

[25]  T. Barnes.  A Rating Scale for Drug-Induced Akathisia , 1989, British Journal of Psychiatry.

[26]  James Robert Brašić,et al.  A children's global assessment scale (CGAS). , 1983, Archives of general psychiatry.

[27]  R. C. Young,et al.  A Rating Scale for Mania: Reliability, Validity and Sensitivity , 1978, British Journal of Psychiatry.

[28]  G. Simpson,et al.  A RATING SCALE FOR EXTRAPYRAMIDAL SIDE EFFECTS , 1970, Acta psychiatrica Scandinavica. Supplementum.

[29]  J. Calabrese,et al.  Double-blind, randomized, placebo-controlled long-term maintenance study of aripiprazole in children with bipolar disorder. , 2012, The Journal of clinical psychiatry.

[30]  J. Newcomer.  Second-Generation (Atypical) Antipsychotics and Metabolic Effects , 2005, CNS drugs.

[31]  C. Altar,et al.  In vivo effects of aripiprazole on cortical and striatal dopaminergic and serotonergic function. , 2004, European journal of pharmacology.

[32]  Nathan Clark.  Consensus development conference on antipsychotic drugs and obesity and diabetes. , 2004, The Journal of clinical psychiatry.

[33]  M. Sorter,et al.  Long-term safety, tolerability, and clinical efficacy of quetiapine in adolescents: an open-label extension trial. , 2003, Journal of child and adolescent psychopharmacology.

[34]  M. Tohen,et al.  A prospective open-label treatment trial of olanzapine monotherapy in children and adolescents with bipolar disorder. , 2001, Journal of child and adolescent psychopharmacology.

[35]  S. Montgomery.  Alternatives to placebo-controlled trials in psychiatry. ECNP Consensus Meeting, September 26, 1996, Amsterdam. European College of Neuropsychopharmacology. , 1999, European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology.

[36]  North American Association for the Study of Obesity , 1991, International journal of obesity.