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

Last updated: February 7, 2025
Sponsor: Janssen Pharmaceutica N.V., Belgium
Overall Status: Completed

Phase

2

Condition

Bipolar Disorder

Mood Disorders

Treatment

Placebo

JNJ-55308942

Clinical Study ID

NCT05328297
CR109116
2021-004790-31
55308942BIP2001
  • Ages 18-64
  • All Genders

Study 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 Criteria

Inclusion

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 psychoticfeatures, as confirmed by the mini international neuropsychiatric interview (MINI)

  • Medically stable on the basis of physical examination, medical history, and vitalsigns performed at screening. Any abnormalities must be consistent with theunderlying illness in the study population. This determination must be recorded inthe 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 sensitiveserum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening anda negative urine pregnancy test before the first dose of study intervention

Exclusion

Exclusion Criteria:

  • Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI

  • Received transcranial magnetic stimulation (TMS), any transcranial electricalstimulation, including transcranial direct current stimulation (tDCS), vagal nervestimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior torandomization

  • History of moderate to severe cannabis misuse according to DSM-5 criteria within 6months before screening

  • History of malignancy within 5 years before screening (exceptions are squamous andbasal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancythat in the opinion of the investigator is considered cured with minimal risk ofrecurrence)

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 03, 2022
Estimated Completion Date:
May 17, 2024

Connect with a study center

  • Foothills Hospital

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • The Medical Arts Health Research Group

    West Vancouver, British Columbia V7T 1C5
    Canada

    Site Not Available

  • Chatham-Kent Clinical Trials Research Centre

    Chatham, Ontario N7L 1C1
    Canada

    Site Not Available

  • Queen's University

    Kingston, K7L 4X3
    Canada

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii

    Bialystok, 15 272
    Poland

    Site Not Available

  • PROMENTE Sp. z o.o.

    Bydgoszcz, 85-133
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, 80-546
    Poland

    Site Not Available

  • Centrum Badań Klinicznych PI-House sp. z o.o.

    Gdansk, 80-546
    Poland

    Active - Recruiting

  • Specjalistyczna Praktyka Lekarska Piotr Zalitacz

    Gorlice, 30073
    Poland

    Site Not Available

  • Centrum Medyczne Care Clinic Katowice

    Katowice, 40-568
    Poland

    Site Not Available

  • Indywidualna Praktyka Lekarska Kinga Bobinska

    Lodz, 90-009
    Poland

    Site Not Available

  • Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego

    Lodz, 91-229
    Poland

    Site Not Available

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

    Poznan, 61-485
    Poland

    Site Not Available

  • Filip Rybakowski Specjalistyczna Praktyka Lekarska

    Poznan, 60 744
    Poland

    Site Not Available

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

    Poznań, 61-485
    Poland

    Site Not Available

  • Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich

    Siemianowice Slaskie, 41-100
    Poland

    Site Not Available

  • Samodzielny Publiczny Zespół Lecznictwa Psychiatrycznego w Siemianowicach Śląskich

    Siemianowice Śląskie, 41-100
    Poland

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

    Suchy Las, 62-002
    Poland

    Site Not Available

  • Osrodek Badan Klinicznych CLINSANTE S.C.

    Torun, 87-100
    Poland

    Site Not Available

  • Instytut Psychiatrii I Neurologii

    Warszawa, 02957
    Poland

    Site Not Available

  • Szpital Nowowiejski Osrodek Badan Klinicznych

    Warszawa, 00-774
    Poland

    Site Not Available

  • Ginemedica Sp. z o.o.

    Wroclaw, 50-414
    Poland

    Site Not Available

  • Przychodnia Lekarsko-Psychologiczna Persona

    Wroclaw, 50-227
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wrocław, 52-415
    Poland

    Site Not Available

  • Ginemedica Sp. z o.o.

    Wrocław, 50-414
    Poland

    Site Not Available

  • Indywidualna Praktyka Lekarska Kinga Bobinska

    Łódź, 90-009
    Poland

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Institucion Hosp Hestia Palau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Centro Salud Mental La Eria

    Oviedo, 33013
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp. El Bierzo

    Ponferrada, 24404
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hosp. Alvaro Cunqueiro

    Vigo, 36213
    Spain

    Site Not Available

  • Hosp. Psiquiatrico Alava

    Vitoria Gasteiz, 1006
    Spain

    Site Not Available

  • Hosp. Psiquiatrico Alava

    Vitoria-Gasteiz, 1006
    Spain

    Site Not Available

  • UAB Huntsville Regional Medical Campus

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Preferred Research Partners

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Synergy East

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Collaborative NeuroScience Network

    Torrance, California 90504
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Neuroscience Solutions

    Orlando, Florida 23801
    United States

    Site Not Available

  • Psychiatric Medicine Associates LLC

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Louisville, Department of Psychiatry

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Center for Emotional Fitness

    Cherry Hill, New Jersey 08002
    United States

    Site Not Available

  • Richard H. Weisler, MD & Associates

    Raleigh, North Carolina 27609-9148
    United States

    Site Not Available

  • Case Western Reserve School of Medicine

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Clinical NeuroScience Solutions Inc

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical NeuroScience Solutions, Inc

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

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

    Austin, Texas 78712-1873
    United States

    Site Not Available

  • North Texas Clinical Trials

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

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