Trials / Completed
CompletedNCT02677207
The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive
The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive Symptoms in 80 Patients With Unipolar or Bipolar Depression: a Phase II Exploratory add-on Double Blind Placebo Controlled 2 Week Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Tangent Data · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric performance and residual depressive symptoms in patients who have been diagnosed with unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major Depression or Manic Episode.
Detailed description
To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric performance and residual depressive symptoms in patients who have been diagnosed with unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major Depression or Manic Episode. Hypothesis: Allosteric modulation of the a7nAChR with JNJ-39393406 improves psychometric performance and residual depressive symptoms in patients with unipolar major depression disorder (MDD) or bipolar depression (BPD). Outcome measurements: * BACS * MADRS * BNSS * CGI-S- BP, * Questionnaire on smoking urges (QSU) and time to the first cigarette after waking up in the morning, * Readiness for discharge scale.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-39393406 | JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial |
| DRUG | Placebo | JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2017-05-01
- Completion
- 2017-07-01
- First posted
- 2016-02-09
- Last updated
- 2020-05-22
Locations
4 sites across 2 countries: Moldova, Romania
Source: ClinicalTrials.gov record NCT02677207. Inclusion in this directory is not an endorsement.