The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
529
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Time frame: Baseline to Day 43
Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score
The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).
Time frame: Baseline to Day 43
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Clinical Site
Rogers, Arkansas, United States
Clinical Site
Cerritos, California, United States
Clinical Site
Costa Mesa, California, United States
Clinical Site
Culver City, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Glendale, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
Oceanside, California, United States
Clinical Site
Pico Rivera, California, United States
Clinical Site
Riverside, California, United States
...and 61 more locations