Phase 2
Completed N=60
Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients
Source: ClinicalTrials.gov NCT02466685 ↗Enrolled (actual)
60
Serious AEs
6.7%
Results posted
Jul 2023
Primary outcomePrimary: The 8-week Evaluation of Verbal Fluency Performance After Randomization — 39.44; 41.12 score on a scale — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The 8-week Evaluation of Verbal Fluency Performance After Randomization |
39.44; 41.12 | <0.05 sig |
| SECONDARY Montgomery-Asberg Depression Rating Scale |
2.93; 3.37; 6.63; 5.89 | — |
| SECONDARY Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8 |
2.78; 2.63; 2.59; 2.37 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Resides in a stable living situation, according to the investigator's judgment.
- Diagnosis of bipolar disorder I or II for at least 1 year in duration, as established by the SCID-I, and verified with medical records and/or confirmation of diagnosis by treating clinician. Patients will be in a nonacute phase at the time of initial screening and have been so for at least 1 month.
- No more than moderate clinical symptom burden severity, as defined by the following: Montgomery Asberg Depression Rating Scale 2.5 times the upper limit of normal (ULN).
- History of stroke, brain tumor, head trauma with loss of consciousness, or other clinically significant neurological condition within 12 months before screening.
- Individuals with other uncontrolled medical conditions, in the opinion of the investigator.
- Use of drugs known to be metabolized by CYP2D6.
Data sourced from ClinicalTrials.gov (NCT02466685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.