None listed
Conditions
Interventions
THE STUDY PLANS TO ENROLL A MINIMUM OF 312 SUBJECTS AND A MAXIMUM OF UP TO APPROXIMATELY 936 SUBJECTS FROM APPROXIMATELY 120 SITES IN NORTH AMERICA AND LATIN AMERICA.
THIS STUDY PLANS TO CONDUCT ON
(2) TO REASSESS SAMPLE SIZE BASED ON THE INTERIM ANALYSIS RESULTS.
SUBJECTS MEETING THE DIAGNOSTIC CRITERIA FROM THE DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS, FOURTH EDITION, TEXT REVI
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. IN THE OPINION OF THE INVESTIGATOR, THE SUBJECT IS CAPABLE OF UNDERSTANDING AND COMPLYING WITH PROTOCOL REQUIREMENTS. 2. THE SUBJECT OR, WHEN APPLICABLE, THE SUBJECT´S LEGALLY ACCEPTABLE REPRESENTATIVE SIGNS AND DATES A WRITTEN, INFORMED CONSENT FORM AND ANY REQUIRED PRIVACY AUTHORIZATION PRIOR TO THE INITIATION OF ANY STUDY PROCEDURES. 3. THE SUBJECT IS A MAN OR WOMAN AGED BETWEEN 18 AND 75 YEARS, INCLUSIVE. 4. THE SUBJECT SUFFERS FROM BIPOLAR 1 DISORDER, MOST RECENT EPISODE DEPRESSED AS THE PRIMARY DIAGNOSIS ACCORDING TO DSM-IV-TR CRITERIA (CLASSIFICATION CODE 296.5X) AND CONFIRMED BY THE STRUCTURED CLINICAL INTERVIEW FOR DSM DISORDERS (SCID). 5. THE REPORTED DURATION OF THE CURRENT MAJOR DEPRESSIVE EPISODE (MDE) IS AT LEAST FOUR WEEKS AND LESS THAN 6 MONTHS. 6. THE SUBJECT HAS A YMRS SCORE OF ≤ 10 BOTH AT THE SCREENING AND BASELINE VISITS. 7. THE SUBJECT HAS A MADRS TOTAL SCORE ≥ 24 AT THE SCREENING AND BASELINE VISITS. 8. THE SUBJECT HAS A CGI-S SCORE OF ≥ 4 AT THE SCREENING AND BASELINE VISITS. 9. HAM- A SCORE IS ≤ 21 AT SCREENING AND BASELINE VISITS.
Exclusion criteria
Exclusion criteria: 1. THE SUBJECT HAS RECEIVED ANY INVESTIGATIONAL COMPOUND <30 DAYS BEFORE SCREENING OR 5 HALF-LIVES WHICHEVER IS LONGER PRIOR TO SCREENING. 2. THE SUBJECT HAS RECEIVED TAK-375 OR TAK-375SL IN A PREVIOUS CLINICAL STUDY OR HAS EVER USED RAMELTEON. 3. THE SUBJECT IS AN IMMEDIATE FAMILY MEMBER, STUDY SITE EMPLOYEE, OR IS IN A DEPENDENT RELATIONSHIP WITH A STUDY SITE EMPLOYEE WHO IS INVOLVED IN CONDUCT OF THIS STUDY (EG, SPOUSE, PARENT, CHILD, SIBLING) OR MAY CONSENT UNDER DURESS. 4. THE SUBJECT HAS ONE OR MORE OF THE FOLLOWING: A. ANY CURRENT PSYCHIATRIC DISORDER WHICH IS THE PRIMARY FOCUS OF TREATMENT OTHER THAN BIPOLAR 1 DISORDER, MOST RECENT EPISODE DEPRESSED AS DEFINED IN THE DSM-IV-TR, AS ASSESSED BY THE SCID. B. CURRENT OR HISTORY OF: SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDER, UNIPOLAR DEPRESSION WITH PSYCHOTIC FEATURES, BIPOLAR DEPRESSION WITH PSYCHOTIC FEATURES, ANY OTHER PSYCHOTIC DISORDER (WITH THE EXCEPTION OF PSYCHOSIS ASSOCIATED WITH A MANIC OR MIXED EPISODE), OCD, MENTAL RETARDATION, ORGANIC MENTAL DISORDERS, OR MENTAL DISORDERS DUE TO A GENERAL MEDICAL CONDITION AS DEFINED IN THE DSM-IV-TR.
Countries
United States
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed