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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
Clinical Psychiatric Hospital
Codru, Moldova
S.C. Stefi-Dent Srl
Botoșani, Romania
Hospital of Psychiatry and Neurology
Brasov, Romania
Spit. Clinic de Urgenta Militar "Dr. Stefan Odobleja"
Craiova, Romania
To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on cognition
Brief Assessment of Cognition (BACS)
Time frame: two weeks - each study visit
To evaluate the effects of JNJ-39393406 on depressive symptoms
Montgomery-Asberg Depression Scale (MADRS)
Time frame: two weeks - each study visit
To evaluate the effects of JNJ-39393406 on residual depressive symptoms
Brief Negative Symptoms Scale (BNSS)
Time frame: two weeks - each study visit
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