At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
JNJ-18038683 +1 moredrug
Likely dose
JNJ-18038683 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Testing the Ability of JNJ(Janssen and Janssen)18038683, a Selective Serotonin (5-HT)7 Antagonist, to Improve Cognition and Reduce Residual Depressive Symptoms in Stable Bipolar Patients (18038683BCD2001)
In Brief
A Phase 2 clinical trial evaluating JNJ-18038683 and Placebo for Bipolar Disorder. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The goals of this study are to evaluate the efficacy of JNJ-18038683 in an 8 week trial to ameliorate the cognitive deficit and reduce residual depressive symptoms in 60 stable bipolar outpatients receiving treatment for depression. JNJ-18038683 will be studied and compared with placebo as adjunctive treatment to standard pharmacologic treatment for bipolar disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartSep 2015
Primary CompletionSep 2021
Study CompletionDec 2022
TodayJul 2026
First PostedJun 9, 2015
Enrollment StartSep 1, 2015
Primary CompletionSep 1, 2021
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 11.1 years ago
Interventions
JNJ-18038683drug
JNJ-18038683 10-20 mg/day tablet for 8 weeks
Placebodrug
placebo tablet daily