Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JNJ-55308942
Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
  • Drug: JNJ-55308942
    JNJ-55308942 capsules will be administered orally.
Placebo Comparator
Placebo
Participants will receive a matching placebo capsule once daily for 6 weeks.
  • Drug: Placebo
    Matching placebo capsules will be administered orally.

Recruiting Locations

UAB Huntsville Regional Medical Campus
Huntsville, Alabama 35801

More Details

Status
Recruiting
Sponsor
Janssen Pharmaceutica N.V., Belgium

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Detailed Description

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 an MDE as assessed by change in Montgomery-├ůsberg Depression Rating Scale (MADRS) total score. Efficacy assessment will include MADRS and safety assessment will include physical examination, adverse events, electrocardiogram (ECG), vital signs, clinical safety laboratory assessments, and suicidal ideation and behavior risk monitoring. Total duration of this study will be up to 12 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.