Your session is about to expire
← Back to Search
Other
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
Study 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 8, 15, 29, 43
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, 15, 29, 43
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Janssen Pharmaceutica N.V., BelgiumLead Sponsor
78 Previous Clinical Trials
29,615 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have symptoms that meet the criteria for a manic episode, as defined by the DSM-5.I haven't had brain stimulation treatments like TMS or DBS in the last 6 weeks.You have a recent history of heavy cannabis use that meets the DSM-5 criteria for moderate to severe misuse.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).You have a primary diagnosis of bipolar disorder (BD) (Type I or II) without psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI).I am medically stable and my BMI is between 18.0 and 35.0.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: JNJ-55308942
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT05328297 — Phase 2
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger