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A Study of JNJ-55308942 in the Treatment of Bipolar Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression

NCT05328297•Janssen Pharmaceutica N.V., Belgium

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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)

Locations (44)

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

Key Dates

Start Date

June 3, 2022

Primary Completion Date

May 17, 2024

Completion Date

May 17, 2024

Last Updated

July 11, 2025

Enrollment

116

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

JNJ-55308942

DRUG

Placebo

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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