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JNJ-18038683 for Bipolar Disorder

Phase 2
Waitlist Available
Led By Herbert Y Meltzer, MD
Research Sponsored by Herbert Meltzer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8
Awards & highlights

Summary

This trial is testing a drug called JNJ-18038683 to see if it can help people with bipolar disorder think more clearly and feel less depressed. The study focuses on patients who are already receiving treatment for depression but still have problems with thinking skills. The drug works by blocking a specific brain receptor to improve memory and mood.

Eligible Conditions
  • Bipolar Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The 8-week Evaluation of Verbal Fluency Performance After Randomization
Secondary study objectives
Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8
Montgomery-Asberg Depression Rating Scale

Side effects data

From 2022 Phase 2 trial • 60 Patients • NCT02466685
7%
Serious Adverse Event
7%
Non-Serious Adverse Events
3%
Serious Adverse events
100%
80%
60%
40%
20%
0%
Study treatment Arm
JNJ-18038683
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-18038683Experimental Treatment1 Intervention
Subjects will be randomized to receive JNJ-18038683 or placebo after the completion of the baseline assessments. Subjects randomized to JNJ-18038683 will receive 10 mg for one week, then titrate to 20 mg for the duration of the trial, with the provision for a single, downward dose adjustment for intolerance, based upon investigator judgment.
Group II: PlaceboPlacebo Group2 Interventions
Placebo treatment for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-18038683
2007
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCIndustry Sponsor
987 Previous Clinical Trials
6,385,599 Total Patients Enrolled
2 Trials studying Bipolar Disorder
529 Patients Enrolled for Bipolar Disorder
Herbert MeltzerLead Sponsor
Herbert Y Meltzer, MDPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
60 Total Patients Enrolled
~6 spots leftby Sep 2025
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