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
Conditions
Interventions
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: equa
Sponsors
Clinirx Tangent Research
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Women of child bearing potential who do not practice contraception. 2.Psychosis, florid manic or major depressive episode during the 4 weeks preceding baseline day or current psychosis. 3.Patients on more than 2 psychotropic (hypnotics for sleep and occasional SOS for agitation do not count). 4.Smokes more than 40 cigarettes per day. 5.Unstable medical disease (malignancy, poorly controlled diabetes, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning. Particular attention should be given to exclude patients with ischemic heart disease). 6.Has a clinically significant abnormal 12-lead electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator. 7.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others. 8.Patients with a current DSM-IV substance or alcohol dependence. 9.Concurrent delirium, mental retardation, drug-induced psychosis, or history of stroke, brain degenerative disorders and brain trauma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Not applicable;Primary end point(s): Composite BACS scores and MADRS scores ;Timepoint(s) of evaluation of this end point: At the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Romania
Contacts
Public ContactPaull G. Radu
Clinirx Tangent Research
Outcome results
None listed