A Study of JNJ-55308942 in the Treatment of Bipolar Depression
NCT ID: NCT05328297
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2022-06-03
2024-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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JNJ-55308942
Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
JNJ-55308942
JNJ-55308942 capsules will be administered orally.
Placebo
Participants will receive a matching placebo capsule once daily for 6 weeks.
Placebo
Matching placebo capsules will be administered orally.
Interventions
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JNJ-55308942
JNJ-55308942 capsules will be administered orally.
Placebo
Matching placebo capsules will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
64 Years
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutica N.V., Belgium Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutica N.V., Belgium
Locations
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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
Suburban Research Associates
Media, Pennsylvania, United States
Clinical NeuroScience Solutions Inc
Memphis, Tennessee, United States
The University of Texas at Austin Department of Psychiatry, Dell Medical School
Austin, Texas, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
The Medical Arts Health Research Group
West Vancouver, British Columbia, Canada
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii
Bialystok, , Poland
PROMENTE Sp. z o.o.
Bydgoszcz, , Poland
Centrum Badan Klinicznych PI House sp z o o
Gdansk, , Poland
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Gorlice, , Poland
Centrum Medyczne Care Clinic Katowice
Katowice, , Poland
Indywidualna Praktyka Lekarska Kinga Bobinska
Lodz, , Poland
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan, , Poland
Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
Poznan, , Poland
Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich
Siemianowice Śląskie, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
Suchy Las, , Poland
Szpital Nowowiejski Osrodek Badan Klinicznych
Warsaw, , Poland
Instytut Psychiatrii I Neurologii
Warsaw, , Poland
Przychodnia Lekarsko-Psychologiczna Persona
Wroclaw, , Poland
Ginemedica Sp. z o.o.
Wroclaw, , Poland
Hosp. Del Mar
Barcelona, , Spain
Institucion Hosp Hestia Palau
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Centro Salud Mental La Eria
Oviedo, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. El Bierzo
Ponferrada, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Hosp. Alvaro Cunqueiro
Vigo, , Spain
Hosp. Psiquiatrico Alava
Vitoria-Gasteiz, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-004790-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
55308942BIP2001
Identifier Type: OTHER
Identifier Source: secondary_id
CR109116
Identifier Type: -
Identifier Source: org_study_id
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