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Study identifier: NCT05328297 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

A Study of JNJ-55308942 in the Treatment of Bipolar Depression

Condition: Bipolar Disorder  ·  Sponsor: Janssen Pharmaceutica N.V., Belgium

PhasePhase 2
Planned participants116
Who can joinAll sexes, 18 Years to 64 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where44 locations · 4 countries

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.

About this study

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.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Locations (44)

UAB Huntsville Regional Medical CampusHuntsville, Alabama, United States
Preferred Research PartnersLittle Rock, Arkansas, United States
Synergy EastLemon Grove, California, United States
Collaborative NeuroScience NetworkTorrance, California, United States
Clinical Neuroscience Solutions IncJacksonville, Florida, United States
Clinical Neuroscience SolutionsOrlando, Florida, United States
Psychiatric Medicine Associates LLCSkokie, Illinois, United States
Indiana UniversityIndianapolis, Indiana, United States
Center for Emotional FitnessCherry Hill, New Jersey, United States
Richard H. Weisler, MD & AssociatesRaleigh, North Carolina, United States
Case Western Reserve School of MedicineCleveland, Ohio, United States
The Ohio State UniversityColumbus, Ohio, United States

+ 32 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

HuntsvilleLittle RockLemon GroveTorrance

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