A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression

  • End date
    May 22, 2024
  • participants needed
  • sponsor
    Janssen Pharmaceutica N.V., Belgium
Updated on 23 October 2022
body mass index
depressive symptoms
depressed mood


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.


JNJ-55308942 is a potent, selective, and brain penetrant antagonist of the adenosine triphosphate (ATP) gated P2X7 receptor. The primary hypothesis that will be tested in this study is that JNJ-55308942, compared to placebo, results in a significant improvement in the reduction of the symptoms of depression in participants with BD in a MDE as assessed by change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Efficacy assessment will include MADRS and safety assessment will include physical examination, electrocardiogram (ECG), vital signs, clinical safety laboratory assessments, and suicidal ideation and behavior risk monitoring. Total duration of this study will be up to 15 weeks.

Condition Bipolar Disorder
Treatment Placebo, JNJ-55308942
Clinical Study IdentifierNCT05328297
SponsorJanssen Pharmaceutica N.V., Belgium
Last Modified on23 October 2022


Yes No Not Sure

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 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

Exclusion Criteria

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