Condition: Bipolar Disorder · Sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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 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 Exclusion Criteria: * 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)
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 32 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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