Phase
Condition
Bipolar Disorder
Mood Disorders
Treatment
Placebo
JNJ-55308942
Clinical Study ID
Ages 18-64 All Genders
Study Summary
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
Connect with a study center
Foothills Hospital
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
The Medical Arts Health Research Group
West Vancouver, British Columbia V7T 1C5
CanadaSite Not Available
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario N7L 1C1
CanadaSite Not Available
Queen's University
Kingston, K7L 4X3
CanadaSite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii
Bialystok, 15 272
PolandSite Not Available
PROMENTE Sp. z o.o.
Bydgoszcz, 85-133
PolandSite Not Available
Centrum Badan Klinicznych PI House sp z o o
Gdansk, 80 546
PolandSite Not Available
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
PolandSite Not Available
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
PolandActive - Recruiting
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Gorlice, 30073
PolandSite Not Available
Centrum Medyczne Care Clinic Katowice
Katowice, 40-568
PolandSite Not Available
Indywidualna Praktyka Lekarska Kinga Bobinska
Lodz, 90-009
PolandSite Not Available
Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego
Lodz, 91-229
PolandSite Not Available
Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
Poznan, 61-485
PolandSite Not Available
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan, 60 744
PolandSite Not Available
Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
Poznań, 61-485
PolandSite Not Available
Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich
Siemianowice Slaskie, 41-100
PolandSite Not Available
Samodzielny Publiczny Zespół Lecznictwa Psychiatrycznego w Siemianowicach Śląskich
Siemianowice Śląskie, 41-100
PolandSite Not Available
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
Suchy Las, 62-002
PolandSite Not Available
Osrodek Badan Klinicznych CLINSANTE S.C.
Torun, 87-100
PolandSite Not Available
Instytut Psychiatrii I Neurologii
Warszawa, 02957
PolandSite Not Available
Szpital Nowowiejski Osrodek Badan Klinicznych
Warszawa, 00-774
PolandSite Not Available
Ginemedica Sp. z o.o.
Wroclaw, 50-414
PolandSite Not Available
Przychodnia Lekarsko-Psychologiczna Persona
Wroclaw, 50-227
PolandSite Not Available
Centrum Medyczne Oporow
Wrocław, 52-415
PolandSite Not Available
Ginemedica Sp. z o.o.
Wrocław, 50-414
PolandSite Not Available
Indywidualna Praktyka Lekarska Kinga Bobinska
Łódź, 90-009
PolandSite Not Available
Hosp Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp. Del Mar
Barcelona, 08003
SpainSite Not Available
Institucion Hosp Hestia Palau
Barcelona, 08025
SpainSite Not Available
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainSite Not Available
Centro Salud Mental La Eria
Oviedo, 33013
SpainSite Not Available
Clinica Univ. de Navarra
Pamplona, 31008
SpainSite Not Available
Hosp. El Bierzo
Ponferrada, 24404
SpainSite Not Available
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainSite Not Available
Hosp. Alvaro Cunqueiro
Vigo, 36213
SpainSite Not Available
Hosp. Psiquiatrico Alava
Vitoria Gasteiz, 1006
SpainSite Not Available
Hosp. Psiquiatrico Alava
Vitoria-Gasteiz, 1006
SpainSite Not Available
UAB Huntsville Regional Medical Campus
Huntsville, Alabama 35801
United StatesSite Not Available
Preferred Research Partners
Little Rock, Arkansas 72211
United StatesSite Not Available
Synergy East
Lemon Grove, California 91945
United StatesSite Not Available
Artemis Institute for Clinical Research
San Diego, California 92103
United StatesSite Not Available
Collaborative NeuroScience Network
Torrance, California 90504
United StatesSite Not Available
Clinical Neuroscience Solutions Inc
Jacksonville, Florida 32256
United StatesSite Not Available
Clinical Neuroscience Solutions
Orlando, Florida 23801
United StatesSite Not Available
Psychiatric Medicine Associates LLC
Skokie, Illinois 60076
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Louisville, Department of Psychiatry
Louisville, Kentucky 40202
United StatesSite Not Available
Center for Emotional Fitness
Cherry Hill, New Jersey 08002
United StatesSite Not Available
Richard H. Weisler, MD & Associates
Raleigh, North Carolina 27609-9148
United StatesSite Not Available
Case Western Reserve School of Medicine
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Suburban Research Associates
Media, Pennsylvania 19063
United StatesSite Not Available
Clinical NeuroScience Solutions Inc
Memphis, Tennessee 38119
United StatesSite Not Available
Clinical NeuroScience Solutions, Inc
Memphis, Tennessee 38119
United StatesActive - Recruiting
The University of Texas at Austin Department of Psychiatry, Dell Medical School
Austin, Texas 78712-1873
United StatesSite Not Available
North Texas Clinical Trials
Fort Worth, Texas 76104
United StatesSite Not Available
The University of Texas Health Science Center at Houston
Houston, Texas 77054
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesSite Not Available
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