A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

• Status: Not yet recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

Summary

A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in the United States, Europe and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion

Criteria

Inclusion Criteria:

Inclusion Criteria (not all inclusive):

• Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

• Subject is 18 to 65 years of age, inclusive, at the time of informed consent.

• Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features.

• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.

• Subject has a MADRS total score ≥ 22 at both Screening and Baseline.

• Subject has a CGI-BP-S depression score ≥ 4 at both Screening and Baseline.

• Subject has a YMRS total score ≤ 12 at both Screening and Baseline.

• Subject is in good physical health, based on medical history, physical examination, neurological examination, vital signs, ECGs, and results of clinical laboratory tests (hematology, chemistry, and urinalysis).

Exclusion Criteria:

Exclusion Criteria (not all inclusive):

• Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment in the past 6 months prior to Screening.

• Subject has a lifetime history of, or symptoms consistent with, a major psychiatric diagnosis other than bipolar I disorder. These include (but are not limited to): schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or post-traumatic stress disorder.

• Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.

• Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study.