Bipolar disorder MedDRA version: 12.1 Level: LLT Classification code 10004936 Term: Bipolar depression
Conditions
Interventions
Product Name: lurasidone
Product Code: SM-13496
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lurasidone
CAS Number: 367514-88-3
Current Sponsor code: SM-13496
Concentration unit: mg mi
Sponsors
Sunovion, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects 18 to 75 years of age inclusive, with bipolar I disorder, most recent episode depressed with or without rapid cycling disease course (= 4 episodes of mood disturbance but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months prior to screening • Subject scores = 4 on MADRS item number 10 (suicidal thoughts) at screening or baseline • History of non-response to an adequate (6-week) monotherapy trial of three or more antidepressants administered within the package-defined therapeutic dose-range (with or without mood stabilizers) during the current episode • Imminent risk of suicide or injury to self, others, or property
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of lurasidone (20-120 mg/day flexibly dosed) in combination with lithium or divalproex compared to placebo (in combination with lithium or divalproex) for the treatment of subjects with bipolar I disorder demonstrating non-response to treatment with lithium or divalproex alone. Subjects most recent episode must be depressed, with or without rapid cycling disease course (= 4 episodes of mood disturbance, but < 8 episodes in the previous 12 months), and without psychotic features (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score. ;Secondary Objective: The key secondary objectives of this study are to evaluate the efficacy of lurasidone (20-120 mg/day, flexibly dosed) in combination with lithium or divalproex as measured by: • Global severity, assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) • Subject self-report of functional impairment associated with bipolar depressive symptoms, assessed by the Sheehan Disability Scale (SDS) total score ;Primary end point(s): Mean change from baseline in MADRS total score after 6 weeks of treatment (Day 42). | — |
Countries
Czech Republic, Lithuania, Slovakia
Outcome results
None listed