None listed
Conditions
Interventions
ALL SUBJECTS WILL BE EVALUATED FOR ELIGIBILITY DURING A SCREENING PERIOD OF 3 TO 14 DAYS. SUBJECTS WILL BE LOWERED OF SELECTED PSYCHOTROPIC MEDICATIONS, WITH THE EXCEPTION OF LITHIUM OR DIVALPROEX, D
4 EPISODES OF MOOD DISTURBANCE BUT < 8 EPISODES IN THE PREVIOUS 12 MONTHS) AND WITHOUT PSYCHOTIC FEATURES (DIAGNOSED BY DSM-IV-TR CRITERIA).
Sponsors
SUNOVION PHARMACEUTICALS INC.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. SUBJECTS PROVIDES WRITTEN INFORMED CONSENT AND IS WILLING AND ABLE TO COMPLY WITH THE PROTOCOL IN THE OPINION OF THE INVESTIGATOR. 2. SUBJECT IS 18 TO 75 YEARS OF AGE INCLUSIVE, WITH BIPOLAR 1 DISORDER, MOST RECENT EPISODE DEPRESSED WITH OR WITHOUT RAPID CYCLING DISEASE COURSE (≥ 4 EPISODES OF MOOD DISTURBANCE BUT < 8 EPISODES IN THE PREVIOUS 12 MONTHS) AND WITHOUT PSYCHOTIC FEATURES (DIAGNOSED BY DSM-IV-TR CRITERIA, AND CONFIRMED BY THE MINI). NOTE: THE CURRENT EPISODE OF MAJOR DEPRESSION ASSOCIATED WITH BIPOLAR 1 DISORDER MUST BY CONFIRMED BY THE INVESTIGATOR AND NOTED IN THE SOURCE RECORDS. 3. SUBJECT HAS A LIFETIME HISTORY OF AT LEAST ONE BIPOLAR MANIC OR MIXED MANIC EPISODE. IT IS STRONGLY RECOMMENDED THAT A RELIABLE INFORMANT (eg., FAMILY MEMBER, CAREGIVER, OR TREATING HEALTH PROFESSIONAL) BE AVAILABLE TO CONFIRM THIS HISTORY. 4. SUBJECT´S CURRENT MAJOR DEPRESSIVE EPISODE IS ≥ 4 WEEKS AND LESS THAN 12 MONTHS IN DURATION. 5. SUBJECT HAS MADRS TOTAL SCORE ≥ 20 (AT BOTH SCREENING AND BASELINE VISITS). 6. SUBJECT HAS YMRS TOTAL SCORE ≤ 12 (AT BOTH SCREENING AND BASELINE VISITS). 7. IT IS RESPONSIBILITY OF THE INVESTIGATOR TO VERIFY WITH SUBJECTS THAT THEY HAVE CONTINUED TREATMENT WITH EITHER LITHIUM OR DIVALPROEX THROUGHOUT THE SCREENING/WASHOUT PERIOD, IF APPLICABLE.
Exclusion criteria
Exclusion criteria: 1. SUBJECT HAS AN AXIS I OR AXIS II DIAGNOSIS OTHER THAN BIPOLAR 1 DISORDER THAT HAS BEEN THE PRIMARY FOCUS OF TREATMENT WITHIN 3 MONTHS OF SCREENING. 2. SUBJECT SCORES ≥ 4 ON MADRS ITEM NUMBER 10 (SUICIDAL THOUGHTS) AT SCREENING OR BASELINE. 3. SUBJECT HAS A HISTORY OF NON-RESPONSE TO AN ADEQUATE (6 WEEKS) MONOTHERAPY TRIAL OF THREE OR MORE ANTIDEPRESSANTS ADMINISTERED WITHIN THE PACKAGE-DEFINED THERAPEUTIC DOSE RANGE (WITH OR WITHOUT MOOD STABILIZERS) DURING THE CURRENT EPISODE. 4. SUBJECT HAS BEEN HOSPITALIZED FOR A MANIC OR MIXED EPISODE WITHIN THE 60 DAYS PRIOR TO RANDOMIZATION. 5. SUBJECT HAS RECEIVED TREATMENT WITH ANTIDEPRESSANTS WITHIN 3 DAYS, FLUOXETINE HYDROCHLORIDE AT ANY TIME WITHIN 28 DAYS, AN MAD INHIBITOR WITHIN 21 DAYS OF RANDOMIZATION OR CLOZAPINE WITHIN 120 DAYS OF RANDOMIZATION. ALL OTHER MEDICATIONS WITH THE EXCEPTIONS OF LITHIUM, DIVALPROEX, LORAZEPAM, TEMAZEPAM AND ZOLPIDEM, REQUIRE 3 DAYS MINIMUM WASHOUT (SEE SECTION 9.2.3. FOR LORAZEPAM, TEMAZEPAM, OR ZOLPIDEM TREATMENT RESTRICTIONS). DEPOT NEUROLEPTICS MUST BE DISCONTINUED AT LEAST ONE TREATMENT CYCLE PRIOR TO RANDOMIZATION.
Countries
Canada, Colombia, Czech Republic, India, Japan, Lithuania, Peru, Slovakia, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed