A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depressio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

Inclusion Criteria

- Subjects 18 to 75 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). 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)
- Lithium or divalproex levels must be within the protocol-defined therapeutic range (0.6-1.2 mEq/L for lithium or 50-125 ug/mL for divalproex) at screening and at least 28 days prior to the screening visit. The lithium or divalproex serum level obtained at least 28 days prior to screening must be documented in source records based on laboratory reports, chart records or communication from a health professional. All preparations of lithium, divalproex (including extended-release formulations), or valproic acid will be permitted.
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

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) 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

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