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
- Diseases
- Bipolar disorder
- 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
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chatham-Kent Clinical Trials Research Centre Coordinator of this site? Confirm its status | Chatham | Canada | Unknown status |
| The Medical Arts Health Research Group Coordinator of this site? Confirm its status | West Vancouver | Canada | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institucion Hosp Hestia Palau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. Ramon Y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Centro Salud Mental La Eria Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp. El Bierzo Coordinator of this site? Confirm its status | Ponferrada | Spain | Unknown status |
| Hosp. Univ. I Politecni La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hosp. Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Hosp. Psiquiatrico Alava Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Psychiatrii Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| PROMENTE Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Specjalistyczna Praktyka Lekarska Piotr Zalitacz Coordinator of this site? Confirm its status | Gorlice | Poland | Unknown status |
| Centrum Medyczne Care Clinic Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Indywidualna Praktyka Lekarska Kinga Bobinska Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Filip Rybakowski Specjalistyczna Praktyka Lekarska Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Centrum Medyczne HCP Sp. z o.o. Osrodek Badan Klinicznych Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Samodzielny Publiczny Zespol Lecznictwa Psychiatrycznego w Siemianowicach Slaskich Coordinator of this site? Confirm its status | Siemianowice Śląskie | Poland | Unknown status |
| Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda Coordinator of this site? Confirm its status | Suchy Las | Poland | Unknown status |
| Instytut Psychiatrii I Neurologii Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Szpital Nowowiejski Osrodek Badan Klinicznych Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Przychodnia Lekarsko-Psychologiczna Persona Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Ginemedica Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| The University of Texas at Austin Department of Psychiatry, Dell Medical School Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Center For Emotional Fitness Coordinator of this site? Confirm its status | Cherry Hill | United States | Unknown status |
| Case Western Reserve School of Medicine Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| North Texas Clinical Trials Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UAB Huntsville Regional Medical Campus Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Clinical NeuroScience Solutions Inc Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Synergy East Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Preferred Research Partners Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Suburban Research Associates Coordinator of this site? Confirm its status | Media | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Clinical Neuroscience Solutions Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Richard H. Weisler, MD & Associates Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Psychiatric Medicine Associates, LLC Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Collaborative NeuroScience Network Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.