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JNJ-55308942 for Bipolar Depression

Phase 2
Recruiting
Research Sponsored by Janssen Pharmaceutica N.V., Belgium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 8, 15, 29, 43
Awards & highlights

Summary

This trial is testing a new medication to see if it can help improve symptoms of depression in people with bipolar disorder who are experiencing a major depressive episode.

Who is the study for?
This trial is for adults with Bipolar Disorder (Type I or II) who are currently not experiencing psychotic features. Participants must have a stable weight (BMI between 18 and 35) and be medically stable. Women of childbearing potential need to test negative for pregnancy. People can't join if they've had recent substance misuse issues, manic episodes, or certain brain stimulation treatments.Check my eligibility
What is being tested?
The study is testing the effectiveness of JNJ-55308942 in treating symptoms of depression in people with bipolar disorder during a major depressive episode. It's compared against a placebo over six weeks to see if it helps improve mood and other related symptoms.See study design
What are the potential side effects?
Potential side effects aren't specified here, but generally, medications like JNJ-55308942 could cause nausea, headache, dizziness, sleep disturbances or changes in appetite among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your body mass index (BMI), which is a measure of your weight in relation to your height, should be between 18 and 35 kilograms per meter squared (kg/m^2).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, 15, 29, 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 8, 15, 29, 43 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
Secondary outcome measures
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Change from Baseline in Generalized Anxiety Disorder 7 (GAD-7) Score.
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-55308942Experimental Treatment1 Intervention
Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a matching placebo capsule once daily for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-55308942
2018
Completed Phase 1
~20

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Bipolar Disorder include mood stabilizers, antipsychotics, and anticonvulsants. Lithium works by modulating neurotransmitter activity and stabilizing mood swings, while valproate increases levels of gamma-aminobutyric acid (GABA) to calm neural activity. Antipsychotics like aripiprazole act on dopamine and serotonin receptors to manage manic and depressive symptoms. Lamotrigine, an anticonvulsant, stabilizes mood by inhibiting glutamate release. These mechanisms are crucial as they help balance mood and prevent extreme highs and lows in Bipolar Disorder patients. JNJ-55308942, a Selective Orexin-2 Receptor Antagonist, targets the orexin system, which is involved in regulating arousal and wakefulness, potentially offering a novel approach to managing depressive episodes in Bipolar Disorder.
Recent advances in treatment of acute mania.Assessing cognitive function in bipolar disorder: challenges and recommendations for clinical trial design.Predictors of response to treatment of acute bipolar manic episodes with divalproex sodium or placebo in 2 randomized, controlled, parallel-group trials.

Find a Location

Who is running the clinical trial?

Janssen Pharmaceutica N.V., BelgiumLead Sponsor
78 Previous Clinical Trials
29,545 Total Patients Enrolled
3 Trials studying Bipolar Disorder
836 Patients Enrolled for Bipolar Disorder
Janssen Pharmaceutica N.V., Belgium Clinical TrialStudy DirectorJanssen Pharmaceutica N.V., Belgium
17 Previous Clinical Trials
3,901 Total Patients Enrolled

Media Library

JNJ-55308942 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05328297 — Phase 2
Bipolar Disorder Research Study Groups: Placebo, JNJ-55308942
Bipolar Disorder Clinical Trial 2023: JNJ-55308942 Highlights & Side Effects. Trial Name: NCT05328297 — Phase 2
JNJ-55308942 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05328297 — Phase 2
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT05328297 — Phase 2
~53 spots leftby Jul 2025