A randomized, 6-week, double-blind, placebo-controlled, fixed-flexible dose, parallel-group study of lurasidone for the treatment of bipolar I depressio
- Conditions
- Bipolar depressionMedDRA version: 14.1Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2008-007457-13-CZ
- Lead Sponsor
- Sunovion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
- Subjects 18 to 65 years of age, with bipolar I disorder, most recent episode 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 DSM-IV-TR criteria, and confirmed by the MINI). The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records.
- Subjects must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member or caregiver) be available to confirm this history.
- Subject’s current major depressive episode is = 4 weeks and less than 12 months in duration.
- MADRS total score = 20 (at both screening and baseline visits)
- YMRS total score = 12 (at both screening and baseline visits)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 520
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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 nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
- Imminent risk of suicide or injury to self, others, or property
-Subject has been hospitalized for a manic or mixed episode within the 60 days prior to randomization
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the efficacy of lurasidone (20-60 mg/day and 80-120 mg/day, flexibly dosed) compared to placebo for the treatment of major depressive episodes associated with bipolar I disorder, most recent episode 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 DSM-IV-TR criteria) as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score.;Secondary Objective: The key secondary objective of this study is to evaluate the efficacy of lurasidone (20-60 mg/day and 80-120 mg/day, flexibly dosed) as measured by the global severity score as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression).;Primary end point(s): Mean change from baseline in MADRS total score after 6 weeks of treatment (Day 42).;Timepoint(s) of evaluation of this end point: Day 42
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The mean change from baseline to endpoint (Week 6) in global severity assessed by the CGI-BP-S score (depression).;Timepoint(s) of evaluation of this end point: Week 6