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

NCT05328297 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR1091162021-004790-3155308942BIP2001
• Study Type: interventional
• Target: 116
• Locations: 4 countries
• Sites: 44

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Week 6

  Change from baseline in MADRS total score up to Week 6 were reported. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant (AD) treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

  From Baseline (Day 1) up to Week 6

Secondary Outcomes (25)

• Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score up to Week 6

  From Baseline (Day 1) up to Week 6

• Change From Baseline in MADRS Total Score up to Week 6 (Genetic Subgroup Analysis)

  From Baseline (Day 1) up to Week 6

• Change From Baseline in MADRS Total Score up to Week 6 (Diagnosis Subgroup Analysis)

  From Baseline (Day 1) up to Week 6

• Change From Baseline in MADRS Total Score up to Week 6 (Biomarker Subgroup Analysis)

  From Baseline (Day 1) up to Week 6

• Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs

  Weeks 1, 2, 4, 6, and 8 (Follow-up/Early Withdrawal)

Study Arms (2)

JNJ-55308942

EXPERIMENTAL

Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.

Drug: JNJ-55308942

Placebo

PLACEBO COMPARATOR

Participants will receive a matching placebo capsule once daily for 6 weeks.

Drug: Placebo

Interventions

JNJ-55308942 DRUG

JNJ-55308942 capsules will be administered orally.

JNJ-55308942

Placebo DRUG

Matching placebo capsules will be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (44)

UAB Huntsville Regional Medical Campus

Huntsville, Alabama, 35801, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Synergy East

Lemon Grove, California, 91945, United States

Location

Collaborative NeuroScience Network

Torrance, California, 90504, United States

Location

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 23801, United States

Location

Psychiatric Medicine Associates LLC

Skokie, Illinois, 60076, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Richard H. Weisler, MD & Associates

Raleigh, North Carolina, 27609-9148, United States

Location

Case Western Reserve School of Medicine

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Clinical NeuroScience Solutions Inc

Memphis, Tennessee, 38119, United States

Location

The University of Texas at Austin Department of Psychiatry, Dell Medical School

Austin, Texas, 78712-1873, United States

Location

North Texas Clinical Trials

Fort Worth, Texas, 76104, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

The Medical Arts Health Research Group

West Vancouver, British Columbia, V7T 1C5, Canada

Location

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, N7L 1C1, Canada

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii

Bialystok, 15 272, Poland

Location

PROMENTE Sp. z o.o.

Bydgoszcz, 85-133, Poland

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

Specjalistyczna Praktyka Lekarska Piotr Zalitacz

Gorlice, 30073, Poland

Location

Centrum Medyczne Care Clinic Katowice

Katowice, 40-568, Poland

Location

Indywidualna Praktyka Lekarska Kinga Bobinska

Lodz, 90-009, Poland

Location

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, 60 744, Poland

Location

Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych

Poznan, 61-485, Poland

Location

Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich

Siemianowice Śląskie, 41-100, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

Suchy Las, 62-002, Poland

Location

Szpital Nowowiejski Osrodek Badan Klinicznych

Warsaw, 00-774, Poland

Location

Instytut Psychiatrii I Neurologii

Warsaw, 02957, Poland

Location

Przychodnia Lekarsko-Psychologiczna Persona

Wroclaw, 50-227, Poland

Location

Ginemedica Sp. z o.o.

Wroclaw, 50-414, Poland

Location

Hosp. Del Mar

Barcelona, 08003, Spain

Location

Institucion Hosp Hestia Palau

Barcelona, 08025, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Centro Salud Mental La Eria

Oviedo, 33013, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp. El Bierzo

Ponferrada, 24404, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36213, Spain

Location

Hosp. Psiquiatrico Alava

Vitoria-Gasteiz, 1006, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

JNJ-55308942

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Director Clinical Sciences Neuroscience
• Organization: Janssen Research & Development

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 14, 2022
• Study Start: June 3, 2022
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (10); US (18); PL (14); CA (2)