A Study of JNJ-55308942 in the Treatment of Bipolar Depression
Completed · Phase 2 · Has a placebo group
Conditions studied: Bipolar Disorder
In brief
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
Key facts
- Study ID
- NCT05328297
- Run by
- Janssen Pharmaceutica N.V., Belgium
- People needed
- 116
- Starts
- 2022-06-03
- Expected to finish
- 2024-05-17
- Last updated by the study team
- 2025-07-11
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI)
- Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- Have a body mass index (BMI) between 18.0 and 35.0 kilograms per meter square (kg/m\^2) inclusive (BMI = weight/height\^2)
- A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test before the first dose of study intervention
You may not qualify if…
- Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
- Received transcranial magnetic stimulation (TMS), any transcranial electrical stimulation, including transcranial direct current stimulation (tDCS), vagal nerve stimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior to randomization
- History of moderate to severe cannabis misuse according to DSM-5 criteria within 6 months before screening
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
Where it is running
- UAB Huntsville Regional Medical Campus — Huntsville, Alabama, United States
- Preferred Research Partners — Little Rock, Arkansas, United States
- Synergy East — Lemon Grove, California, United States
- Collaborative NeuroScience Network — Torrance, California, United States
- Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
- Clinical Neuroscience Solutions — Orlando, Florida, United States
- Psychiatric Medicine Associates LLC — Skokie, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- Center for Emotional Fitness — Cherry Hill, New Jersey, United States
- Richard H. Weisler, MD & Associates — Raleigh, North Carolina, United States
- Case Western Reserve School of Medicine — Cleveland, Ohio, United States
- The Ohio State University — Columbus, Ohio, United States
- Suburban Research Associates — Media, Pennsylvania, United States
- Clinical NeuroScience Solutions Inc — Memphis, Tennessee, United States
- The University of Texas at Austin Department of Psychiatry, Dell Medical School — Austin, Texas, United States
- North Texas Clinical Trials — Fort Worth, Texas, United States
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
- Northwest Clinical Research Center — Bellevue, Washington, United States
- The Medical Arts Health Research Group — West Vancouver, British Columbia, Canada
- Chatham-Kent Clinical Trials Research Centre — Chatham, Ontario, Canada
- Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii — Bialystok, Poland
- PROMENTE Sp. z o.o. — Bydgoszcz, Poland
- Centrum Badan Klinicznych PI House sp z o o — Gdansk, Poland
- Specjalistyczna Praktyka Lekarska Piotr Zalitacz — Gorlice, Poland
- Centrum Medyczne Care Clinic Katowice — Katowice, Poland
Full record on ClinicalTrials.gov
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