A Randomized, 6-Week, Double-Blind, Placebo-controlled, Fixed-Flexible-Dose, Parallel-Group Study of Lurasidone in the Treatment of Bipolar I Depressio
- Conditions
- Bipolar depressionMedDRA version: 9.1Level: LLTClassification code 10004936Term: Bipolar depression
- Registration Number
- EUCTR2008-007457-13-FR
- Lead Sponsor
- Dainippon Sumitomo Pharma America Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 485
- Subjects 18 to 75 years of age, with bipolar I disorder, most recent episode depressed withor 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). 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
F.1.3 Elderly (>=65 years) yes
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
- Secondary Outcome Measures
Name Time Method