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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
All participants must have signed an informed consent document indicating they understand the purpose of the study and the procedures required for the study and are willing to participate by complying with the study procedures and restrictions.
Male or female individuals of any race; between 18 to 60 years of age, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8
Awards & highlights

Study Summary

This trial will study JNJ-18038683 to see if it helps with cognitive deficits and residual depressive symptoms in bipolar patients who are already receiving treatment for depression.

Eligible Conditions
  • Bipolar Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The 8-week Evaluation of Verbal Fluency Performance After Randomization
Secondary outcome measures
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
973 Previous Clinical Trials
6,383,662 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

Frequently Asked Questions

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

For whom does this study hold the most potential?

"This clinical trial is seeking 60 individuals with a history of manic disorder who are between 18-60 years old. The ideal candidate will meet the following requirements:- Receiving a single mood stabilizer (e.g., lithium, valproate, or lamictal) for at least 2 months with a stable dose- Medically stable enough to complete an 8-week clinical trial, as judged by the investigator- Negative pregnancy serum and urine test at screening and baseline, respectively. Willing to use adequate protection (i.e. double barrier method) for birth control- Taking antidepressants, mood stabil"

Answered by AI

What are the harmful effects that JNJ-18038683 might have on patients?

"JNJ-18038683's safety is estimated to be a 2. This is because, while there is some data supporting safety, there is none for efficacy."

Answered by AI

Would this study be appropriate for elderly patients?

"According to the requirements for this clinical trial, patients must be aged 18 to 60. For context, there are 204 studies for people under the age of 18 and 931 for patients over 65."

Answered by AI

Can new volunteers still join this research project?

"Data from clinicaltrials.gov suggests that this particular medical trial is not actively recruiting patients at the moment. Although, there are 1279 other trials that are recruiting patients."

Answered by AI
~6 spots leftby Mar 2025