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

INTERVENTION: Product Code: JNJ‐39393406 Pharmaceutical Form: Capsule INN or Proposed INN: N/A CAS Number: 953428‐73‐4 Current Sponsor code: JNJ‐39393406 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] Unipolar and bipolar depression ; MedDRA version: 19.0 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 100000004873 ; MedDRA version: 19.0 Level: LLT Classification code 10045543 Term: Unipolar depression System Organ Class: 100000004873 PRIMARY OUTCOME: Main Objective: 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. Primary end point(s): Composite BACS scores and MADRS scores Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: At the end of the trial. SECONDARY OUTCOME: Secondary end point(s): ‐ BNSS ; ‐ CGI‐S‐ BP, ; ‐ Questionnaire on smoking urges (QSU) and time to the first cigarette after waking up in the morning, ; Timepoint(s) of evaluation of this end point: The end of the trial. INCLUSION CRITERIA: 1.Meet DSM V criteria for history of MDD or BPD by MINI. 2.Between 18‐50 years of age, male or female subjects of any race, smokers and non‐smokers. 3.Able to provide informed consent. All participant patients 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. 4.Have a MADRS = 10 and = 34 and an YMRS < 7. 5.In the opinion of the investigator, basic education and severity of symptoms (psychotic, negative, manic, agitation, depression) do not prevent the patient from attending to the cognitive tasks. 6.In the opinion of the investigator the patient can be safely treated with no more than 2 psychotropic medications as background therapy (SOS for agitation and sleeping medication are allowed in addition to the 2 psychotropics). 7.The background psychotropic(s) that w