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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Depressive Episodes, Bipolar I Depression

In brief

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 approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.

Key facts

Study ID

NCT05169710

Run by

Sumitomo Pharma America, Inc.

People needed

83

Starts

2021-12-21

Expected to finish

2023-10-18

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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, or is currently being treated with concomitant medication
• Subject has a lifetime history of, or symptoms consistent with, schizophrenia, schizoaffective disorder, or a major psychiatric diagnosis other than bipolar I disorder that is judged to pose risk to the study scientific objectives
• 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.

Where it is running

• Sanro Clinical Research Group LLC — Bryant, Arkansas, United States
• Advanced Research Center, Inc. — Anaheim, California, United States
• Sun Valley Research Center — Imperial, California, United States
• Clinical innovations, Inc. — Riverside, California, United States
• Siyan Clinical Research — Santa Rosa, California, United States
• Collaborative Neuroscience Research, LLC — Torrance, California, United States
• Vertex Research Group — Clermont, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Premier Clinical Research Institute, Inc. — Miami, Florida, United States
• Central Miami Medical Institute — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• GCP Clinical Research LLC — Tampa, Florida, United States
• Atlanta Behavioral Research, LLC — Atlanta, Georgia, United States
• Psych Atlanta, P.C. — Marietta, Georgia, United States
• AMR Conventions Research — Warrenville, Illinois, United States
• Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine — Louisville, Kentucky, United States
• St. Charles Psychiatric Associates / Midwest Research Group — Saint Charles, Missouri, United States
• Alivation Research, LLC — Lincoln, Nebraska, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Global Medical Institutes, LLC — Princeton, New Jersey, United States
• UB Department of Psychiatry — Buffalo, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Richmond Behavioral Associates ERG Clinical Research - New York PLLC — Staten Island, New York, United States
• University of Alabama at Birmingham Huntsville Regional Medical Campus — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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