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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

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 below
Select...
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

Find a Location

Who is running the clinical trial?

Janssen Pharmaceutica N.V., BelgiumLead Sponsor
78 Previous Clinical Trials
29,631 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
3,917 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what locations can one access this clinical trial?

"Patients interested in this trial can apply at Psychiatric Medicine Associates LLC in Skokie, Illinois, Suburban Research Associates in Media, Pennsylvania and UAB Huntsville Regional Medical Campus in Huntsville, Alabama among other 22 sites."

Answered by AI

Does this research study permit participation from those under the age of 30?

"In accordance with the parameters of this research programme, individuals between 18 and 64 years old are eligible to partake."

Answered by AI

Are there any open enrollments for this clinical experiment?

"Affirmative. According to the clinicaltrials.gov records, this medical trial began recruitment on June 3rd 2022 and is still open for new patients as of November 9th 2022. 164 participants are needed from 22 locations throughout the country."

Answered by AI

What is the current participant count in this research endeavor?

"Affirmative. Information on clinicaltrials.gov verifies that this research is actively searching for volunteers, with the initial posting having been made June 3rd 2022 and a subsequent update occurring November 9th 2022. The study requires 164 participants to be recruited from 22 distinct locations."

Answered by AI

Is participation in this research opportunity open?

"This medical trial is currently looking to enrol 164 adults aged 18-64 with a diagnosis of bipolar disorder (type I or II) without psychotic features, as established by the MINI. Moreover, participants must have a BMI between 18 and 35 kg/m^2 inclusive and female candidates of childbearing potential are required to present negative results for both their serum pregnancy test at screening and urine pregnancy tests prior to receiving any study intervention."

Answered by AI

Has JNJ-55308942 received the endorsement of federal regulators?

"The safety of JNJ-55308942 is rated as a 2; given that this is still in its second phase, there has been some evidence for the drug's security but no studies demonstrating efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Texas
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
Indiana University
UAB Huntsville Regional Medical Campus
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
3+

Why did patients apply to this trial?

I'm hoping this trial will help me. I am looking for a clinical trial for my bipolar depression.
PatientReceived 1 prior treatment
i’m averagely bipolar i want to find soemthing that works for me. I have tried several drugs and I am hoping that your clinical study will meet my needs.
PatientReceived 1 prior treatment
IVE TRIED ALOT OF OTHER DRUGS TO HELP ME BUT NONE HAVE WORKED HOPEING THIS TRIAL HELPS.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Will I be paid for this trail? If I’m given a placebo will I eventually be give the real meds?
PatientReceived 2+ prior treatments
Can I schedule visits on Mondays or can the visits be around my current work schedule since I just started a new job?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. UAB Huntsville Regional Medical Campus: < 24 hours
  2. The University of Texas Health Science Center at Houston: < 24 hours
  3. Indiana University: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
2022. "A Study of JNJ-55308942 in the Treatment of Bipolar Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05328297.
All > Bipolar Disorder
~58 spots leftby Apr 2025
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