A Study of JNJ-55308942 in the Treatment of Bipolar Depression
S
Susan Conroy, MD
Primary Investigator
Overview
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo onymptoms of depression in participants with bipolar disorder (BD) in a major depressivede (MDE) at Week 6.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Bipolar Disorder
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Age: Between 18 Years - 64 Years
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Gender: All
Inclusion Criteria:
- 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 psychoticures, as confirmed by the mini international neuropsychiatric interview (MINI)
- Medically stable on the basis of physical examination, medical history, and vitalgns performed at screening. Any abnormalities must be consistent with the underlyinghe study population. This determination must be recorded in theurce 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)usive (BMI = weight/height^2)
- A woman of childbearing potential (WOCBP) must have a negative highly sensitive serumgnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and agative urine pregnancy test before the first dose of study intervention
Exclusion Criteria:
- Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
- Received transcranial magnetic stimulation (TMS), any transcranial electricalulation, including transcranial direct current stimulation (tDCS), vagal nerveulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior todomization
- History of moderate to severe cannabis misuse according to DSM-5 criteria within 6hs before screening
- History of malignancy within 5 years before screening (exceptions are squamous andbasal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancyhat in the opinion of the investigator is considered cured with minimal risk ofurrence)
Updated on
02 May 2024.
Study ID: CR109116
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