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NCT05328297CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 11 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
116 (actual)
First submitted
11 Apr 2022
Start date
3 Jun 2022
Primary completion date
17 May 2024
Lead sponsor
Janssen Pharmaceutica N.V., Belgium
NCT number
NCT05328297
EudraCT number
2021-004790-31

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 116
  • From 3 Jun 2022 to the primary completion date, 17 May 2024
  • 44 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chatham-Kent Clinical Trials Research Centre
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ChathamCanadaUnknown status
The Medical Arts Health Research Group
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West VancouverCanadaUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Institucion Hosp Hestia Palau
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BarcelonaSpainUnknown status
Hosp. Del Mar
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BarcelonaSpainUnknown status
Hosp. Univ. Ramon Y Cajal
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MadridSpainUnknown status
Centro Salud Mental La Eria
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OviedoSpainUnknown status
Clinica Univ. de Navarra
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PamplonaSpainUnknown status
Hosp. El Bierzo
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PonferradaSpainUnknown status
Hosp. Univ. I Politecni La Fe
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ValenciaSpainUnknown status
Hosp. Alvaro Cunqueiro
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VigoSpainUnknown status
Hosp. Psiquiatrico Alava
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Vitoria-GasteizSpainUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii
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BialystokPolandUnknown status
PROMENTE Sp. z o.o.
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BydgoszczPolandUnknown status
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandUnknown status
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
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GorlicePolandUnknown status
Centrum Medyczne Care Clinic Katowice
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KatowicePolandUnknown status
Indywidualna Praktyka Lekarska Kinga Bobinska
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LodzPolandUnknown status
Filip Rybakowski Specjalistyczna Praktyka Lekarska
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PoznanPolandUnknown status
Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych
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PoznanPolandUnknown status
Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich
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Siemianowice ŚląskiePolandUnknown status
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
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Suchy LasPolandUnknown status
Instytut Psychiatrii I Neurologii
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WarsawPolandUnknown status
Szpital Nowowiejski Osrodek Badan Klinicznych
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WarsawPolandUnknown status
Przychodnia Lekarsko-Psychologiczna Persona
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WroclawPolandUnknown status
Ginemedica Sp. z o.o.
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WroclawPolandUnknown status
The University of Texas at Austin Department of Psychiatry, Dell Medical School
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AustinUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Center For Emotional Fitness
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Cherry HillUnited StatesUnknown status
Case Western Reserve School of Medicine
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ClevelandUnited StatesUnknown status
The Ohio State University
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ColumbusUnited StatesUnknown status
North Texas Clinical Trials
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Fort WorthUnited StatesUnknown status
The University of Texas Health Science Center at Houston
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HoustonUnited StatesUnknown status
UAB Huntsville Regional Medical Campus
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HuntsvilleUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Clinical NeuroScience Solutions Inc
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JacksonvilleUnited StatesUnknown status
Synergy East
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Lemon GroveUnited StatesUnknown status
Preferred Research Partners
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Little RockUnited StatesUnknown status
Suburban Research Associates
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MediaUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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MemphisUnited StatesUnknown status
Clinical Neuroscience Solutions
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OrlandoUnited StatesUnknown status
Richard H. Weisler, MD & Associates
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RaleighUnited StatesUnknown status
Psychiatric Medicine Associates, LLC
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SkokieUnited StatesUnknown status
Collaborative NeuroScience Network
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TorranceUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.