Quetiapine or Lithium Versus Placebo for Maintenance Treatment of Bipolar I Disorder After Stabilization on Quetiapine

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
W.A. Nolen ◽  
R.H. Weisler ◽  
A. Neijber ◽  
Å. Hellqvist ◽  
B. Paulsson
Keyword(s):  
Bipolar Disorder ◽  
Interim Analysis ◽  
Maintenance Treatment ◽  
Additional Benefit ◽  
Study Medication ◽  
Open Label ◽  
Double Blind ◽  
Bipolar I Disorder ◽  
Time To Recurrence ◽  
Positive Results

Purpose:Quetiapine combined with lithium or divalproex is an effective maintenance treatment for bipolar I disorder.1,2 This double-blind, randomized trial (D1447C00144) investigated quetiapine monotherapy as maintenance treatment.Methods:Adults experiencing manic, depressed, or mixed episodes of bipolar disorder received open-label quetiapine. Patients achieving stabilization (YMRS ≤12 and MADRS ≤12, 4 consecutive weeks) were randomized to continue quetiapine (300-800 mg/d) or to switch to placebo or lithium (target serum 0.6-1.2 mEq/L) for up to 104 weeks or recurrent mood event. The primary endpoint was time to recurrence of any mood event. The study was terminated when interim analysis provided positive results.Results:Of 2438 patients starting open-label quetiapine, 1226 (50.3%) were randomized to study medication with 1172 in the ITT population. Mean median quetiapine dose was 546 mg/d; mean median lithium serum level was 0.63 mEq/L. Time to recurrence of any mood event was longer for continued quetiapine versus switching to placebo (HR, 0.29; 95% CI, 0.23-0.38; P< 0.0001), for switching to lithium versus switching to placebo (HR, 0.46; 95% CI, 0.36-0.59; P< 0.0001), and for continued quetiapine versus switching to lithium (HR, 0.66; 95% CI, 0.49-0.88; P=0.005). Safety findings were consistent with known profiles.Conclusions:In patients stabilized on quetiapine, continued quetiapine significantly decreased time to recurrence of any mood event versus switching to placebo. Switching to lithium was also more effective than switching to placebo and conferred no additional benefit versus continuing quetiapine.Supported by funding from AstraZeneca Pharmaceuticals LP.

Lurasidone Adjunctive to Lithium or Valproate for Prevention of Recurrence in Patients with Bipolar I Disorder

2017 ◽  
Vol 41 (S1) ◽  
pp. S209-S209
Author(s):  
J. Calabrese ◽  
A. Pikalov ◽  
J. Cucchiaro ◽  
Y. Mao ◽  
A. Loebel
Keyword(s):  
Bipolar Disorder ◽  
Bipolar Depression ◽  
Hazard Ratio ◽  
Open Label ◽  
Recurrence Rates ◽  
Double Blind ◽  
Bipolar I Disorder ◽  
Risk Of Recurrence ◽  
Advisory Boards ◽  
Time To Recurrence

IntroductionInformation is not available on the maintenance efficacy of lurasidone in bipolar disorder.Objectives/aimsTo evaluate the recurrence prevention efficacy of lurasidone plus lithium (Li) or valproate (VPA) for the maintenance treatment of bipolar disorder.MethodsPatients with bipolar I disorder received up to 20 weeks of open-label lurasidone (20–80 mg/d) plus Li or VPA. Patients who achieved consistent clinical stability were randomized to 28 weeks of double-blind treatment with lurasidone (20–80 mg/d) or placebo, plus Li or VPA.ResultsA total of 496 patients met stabilization criteria and were randomized to adjunctive lurasidone vs. placebo. Fewer patients in the lurasidone group had recurrence of any mood episode compared with the placebo group, with a hazard ratio of 0.71 (P = 0.078). In pre-planned secondary analyses, recurrence rates were significantly lower for the lurasidone group treated with a modal open-label dose of 80 mg/d (hazard ratio [HR], 0.35; P = 0.020); when patients presented with an index episode of depression (HR = 0.57; P = 0.039); and when outcome was time-to-all-cause discontinuation (HR = 0.72; P = 0.034), or time-to-recurrence based on symptom severity criteria (HR = 0.53; P = 0.025).ConclusionsIn patients stabilized on lurasidone plus Li or VPA, continued treatment was associated with non-significant reduction in risk of recurrence of any mood disorder (primary). Consistent with dose-response effects observed during acute treatment of bipolar depression, risk of recurrence on lurasidone was significantly reduced after open-label treatment with the 80 mg/d dose, and in the 20–80 mg/d dose in patients presenting with an index episode of depression.Clinicaltrials.gov: NCT01358357.Sponsored by Sunovion Pharmaceuticals Inc.Disclosure of interestDrs. Pikalov, Cucchiaro, Mao, and Loebel are employees of Sunovion Pharmaceuticals IncDr. Calabrese has received research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Cephalon, Cleveland Foundation, Eli Lilly, GlaxoSmithKline, Janssen, Lundbeck, NARSAD, Repligen, Stanley Medical Research Institute, Takeda, and Wyeth. Dr. Calabrese consulted to or served on advisory boards of Abbott, AstraZeneca, Bristol-Myers Squibb, Cephalon, Dainippon Sumitomo, Elan, EPI-Q, Inc., Forest, France Foundation, GlaxoSmithKline, Hoffman LaRoche, Janssen, Johnson and Johnson, Lundbeck, Merck, Neurosearch, OrthoMcNeil, Otsuka, Pfizer, Repligen, Servier, Solvay, Sunovion, Supernus, Synosia, Takeda, Teva, and Wyeth. Dr. Calabrese has provided CME lectures supported by AstraZeneca, Bristol-Myers Squibb, France Foundation, GlaxoSmithKline, Janssen, Johnson and Johnson, Merck, Sanofi-Aventis, Schering-Plough, Pfizer, Solvay, Sunovion, and Wyeth.

scholarly journals A 6-month, Randomized, Placebo-controlled, Double Blind Trial of Ziprasidone Plus a Mood Stabilizer in Subjects With Bipolar I Disorder

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
E. Vieta ◽  
C. Bowden ◽  
K. Ice ◽  
O. Gurtovaya ◽  
J. Schwartz ◽  
...  
Keyword(s):  
Maintenance Treatment ◽  
Mood Stabilizer ◽  
Adjunctive Treatment ◽  
Rank Test ◽  
Open Label ◽  
Double Blind ◽  
Bipolar I Disorder ◽  
Mood Episode ◽  
Bipolar Mania ◽  
Group 5

Background:The objective of this study was to evaluate the efficacy and safety of ziprasidone adjunctive to a mood stabilizer for the maintenance treatment of bipolar mania.Methods:Male and female subjects with bipolar I disorder with MRS 3 14 were enrolled. Subjects achieving ≥ 8 consecutive weeks of stability with open-label ziprasidone (80-160 mg/d) and lithium or divalproex were randomized into the 6-month double-blind maintenance period, to ziprasidone + mood stabilizer or placebo + mood stabilizer. The primary and key secondary end points were the time to intervention for a mood episode, and time to discontinuation for any reason, respectively. Inferential analysis was performed using a Kaplan-Meier product-limit estimator (Log-rank test).Results:127 and 112 subjects were randomized to and treated in the ziprasidone and placebo groups, respectively. The time to intervention for a mood episode was significantly different, favoring ziprasidone (p = 0.0104). 19.7% and 32.4% of ziprasidone and placebo subjects, respectively, required intervention for a mood episode. Time to discontinuation for any reason was significantly different (p = 0.0047), favoring ziprasidone. Among treatment-emergent adverse events occurring in the double-blind period, the only event occurring more frequently in the ziprasidone group than in the placebo group (≥ 5%) was tremor (6.3% vs 3.6%, respectively).Conclusions:These results demonstrate that ziprasidone is an effective, safe, and well-tolerated adjunctive treatment with a mood stabilizer for long-term maintenance treatment of bipolar mania.

scholarly journals Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study

2018 ◽  
Vol 6 (1) ◽  
Author(s):  
Joseph R. Calabrese ◽  
Na Jin ◽  
Brian Johnson ◽  
Pedro Such ◽  
Ross A. Baker ◽  
...  
Keyword(s):  
Maintenance Treatment ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Bipolar I Disorder

Bipolar Disorder in Children and Adolescents

CNS Spectrums ◽  
2003 ◽  
Vol 8 (12) ◽  
pp. 954-959 ◽  
Author(s):  
Dwight V. Wolf ◽  
Karen Dineen Wagner
Keyword(s):  
Bipolar Disorder ◽  
Children And Adolescents ◽  
Psychosocial Development ◽  
Age Of Onset ◽  
Mood Stabilizers ◽  
Diagnostic Challenge ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Combination Treatments

AbstractThere is increased recognition that bipolar disorder has an early age of onset. The prevalence of bipolar disorder in prepubertal children has not been determined, however the prevalence in adolescence is ˜1%. Bipolar disorder in children poses a diagnostic challenge since the symptoms may differ from those in late adolescence and adulthood. Comorbid disorders, such as attention-deficit/hyperactivity disorder, further complicate both the diagnosis and course of the disorder. There is increasing evidence of the chronicity and severity of this disorder in youths. Bipolar disorder significantly disrupts a child's psychosocial development including impairments in academic functioning, family functioning, and relationship with peers. Although this disorder has significant morbidity in children and adolescents, there is a paucity of controlled studies to assess the efficacy and safety of mood stabilizers in the treatment of this disorder in youths. The treatment literature consists largely of case studies, retrospective chart reviews, and open-label studies. There is a compelling need for double-blind, placebo-controlled trials to determine whether commonly used medications to treat this disorder are significantly superior to placebo. Since many children in clinical practice require more than one psychotropic medication to adequately manage this disorder, studies of combination treatments are warranted. This review will provide an overview of the literature of bipolar disorder in children and adolescents, including discussion of the prevalence, diagnosis, epidemiology, course of the illness, and treatment issues.

An Open-Label Trial of Aripiprazole Monotherapy in Children and Adolescents with Bipolar Disorder

CNS Spectrums ◽  
2007 ◽  
Vol 12 (9) ◽  
pp. 683-689 ◽  
Author(s):  
Joseph Biederman ◽  
Eric Mick ◽  
Thomas Spencer ◽  
Robert Doyle ◽  
Gagan Joshi ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Vital Signs ◽  
Pediatric Bipolar Disorder ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Scale Scores ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

ABSTRACTIntroduction: Aripiprazole is a novel second-generation antipsychotic approved for the treatment of bipolar disorder in adults but there is no systematic data available in pediatric bipolar disorder.Methods: This was an 8-week, open-label, prospective study of aripiprazole 9.4±4.2 mg/day monotherapy to assess the efficacy and tolerability of this compound in treating pediatric bipolar disorder. Assessments included the Young Mania Rating Scale, Clinical Global Impressions-Improvement scale, and Brief Psychiatric Rating Scale. Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis.Results: Fifteen of the 19 bipolar youth (79%) completed the study. Aripiprazole treatment was associated with clinically and statistically significant improvement in mean Young Mania Rating Scale scores (−18.0±6.9, P<.0001). With the important exception of two cases of extrapyramidal symptoms that precipitated dropout, aripiprazole was well tolerated with no statistically significant increase in body weight (1.8±1.7 kg, P=.2).Conclusion: Open-label aripiprazole treatment was beneficial in the treatment of mania in youth with bipolar disorder. Future placebo-controlled, double blind studies are warranted.

scholarly journals 154 Functioning in de Novo and Rollover Patients with Bipolar I Disorder Receiving Aripiprazole Once-monthly in a 52-Week, Open-label Study

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 298-299
Author(s):  
Jessica J Madera ◽  
Pedro Such ◽  
Maxine Chen ◽  
Ross A Baker
Keyword(s):  
Depressive Symptoms ◽  
Maintenance Treatment ◽  
Rating Scale ◽  
De Novo ◽  
Open Label ◽  
Safety Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Term Maintenance

Abstract:Introduction:Long-term maintenance treatment is essential in management of bipolar I disorder (BP-I) to achieve mood stability, prevent recurrence of mood episodes and improve functioning. Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting formulation of aripiprazole for maintenance treatment of BP-I. In a double-blind, placebo-controlled, randomized withdrawal study in adult patients with BP-I after a manic episode (NCT01567527), AOM 400 delayed time to and reduced rate of recurrence of mood episodes and was safe and well tolerated (1). In an open-label, long-term safety study (NCT01710709), AOM 400 was safe and effective as long-term maintenance treatment (2).Objective:To evaluate the effect of long-term AOM 400 maintenance treatment on manic and depressive symptoms in BP-I patients from the open-label, long term safety study.Methods:Manic and depressive symptoms were assessed post-hoc by analysis of change from study entry in the Young-Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and line item scores. The mean changes from baseline at last visit in YMRS and MADRS total scores, and single items were calculated using descriptive statistics, using last observation carried forward for total scores and observed cases for single items.Results:A total of 464 patients entered the maintenance phase: 379 were de novo and 85 were rollover patients who completed the double-blind, placebo-controlled withdrawal study. Overall, 63% (291/464) completed 52 weeks of open-label treatment. Mean YMRS and MADRS total scores were minimally changed from baseline (YMRS: 2.31, endpoint change -0.30; MADRS: 3.23, endpoint change +1.24) across the study in the total population.Conclusion:Patients entering an open-label safety study with stable manic and depressive symptoms maintained stability in both types of symptoms, as shown by minimal mean changes from baseline in YMRS and MADRS scores, suggesting that treatment with AOM 400 is effective in preventing re-emergence of both manic and depressive symptoms.Funding Acknowledgements:The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.

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