A Study of JNJ-55308942 in the Treatment of Bipolar Depression

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Bipolar Disorder

Treatments: Drug: Placebo; Drug: JNJ-55308942

Study type: Interventional

Funder types: Industry

Identifiers

NCT05328297

2021-004790-31 (EudraCT Number)

55308942BIP2001 (Other Identifier)

CR109116

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups, including a placebo group

JNJ-55308942

Experimental group

Description:

Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.

Treatment:

Drug: JNJ-55308942

Placebo

Placebo Comparator group

Description:

Participants will receive a matching placebo capsule once daily for 6 weeks.

Treatment:

Drug: Placebo