A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE A DAY, TAK-375SL 0.1, 0.4, AND 0.8 MG AS AN ADJUNCTIVE THERAPY TO TREATMENT-AS-USUAL IN THE MAINTENANCE TREATMENT OF BIPOLAR 1 DOSORDER IN ADULT SUBJECTS

TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,0 个研究点目标入组 0 人开始时间: 2013年8月2日最近更新: 2023年9月4日

研究概览

暂无简介。

•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 SUFFERS FROM BIPOLAR 1 DISORDER, ACCORDING TO DSM-IV-TR CRITERIA AND IS CONFIRMED BY THE STRUCTURED CLINICAL INTERVIEW FOR DSM DISORDERS (SCID).
•4. THE SUBJECT IS A MAN OR WOMAN AGED BETWEEN 18 AND 75 YEARS, INCLUSIVE.
•5. THE SUBJECT HAS AN IDENTIFIED CAREGIVER OR PERSON RESPONSIBLE (EG. FAMILY MEMBER, SPOUSE, CASE WORKER OR NURSE AT A RESIDENTIAL LIVING (FACILITY)) THAT IS CONSIDERED RELIABLE BY THE INVESTIGATOR.
•6. THE MOST RECENT MOOD EPISODE (DEPRESSION, MANIA, HYPOMANIA, MIXED EPISODE) IS BETWEEN 8 WEEKS AND 9 MONTHS PRIOR TO SCREENING.
•7. THE SUBJECT HAS BEEN STABLE IN THE OPINION OF THE PI FOR AT LEAST 8 WEEKS PRIOR TO BASELINE FROM THEIR MOST RECENT MOOD EPISODE.
•8. THE SUBJECT HAS A MADRS TOTAL SCORE ≤ 1AT THE SCREENING AND BASELINE VISITS.
•9. THE SUBJECT HAS A YMRS SCORE OF ≤ 10 BOTH AT THE SCREENING AND BASELINE VISITS.
•10. THE SUBJECT HAS A CGI-S SCORE OF ≤ 2 AT THE SCREENING AND BASELINE VISITS.

•1. THE SUBJECT HAS RECEIVED ANY INVESTIGATIONAL COMPOUND < 30 DAYS BEFORE SCREENING OR 5 HALF-LIVES PRIOR TO SCREENING, WHICHEVER IS LONGER.
•2. THE SUBJECT HAS EVER 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 AS DEFINED IN THE DSM-IV-TR, AS ASSESSED BY THE SCID.
•B) CURRENT OR HISTORY OF SCHIZOPHRENIA OR ANY OTHER PSYCHOTIC DISORDER, SCHIZOAFFECTIVE DISORDER, INCLUDING MAJOR DEPRESSION WITH PSYCHOTIC FEATURES, BIPOLAR DEPRESSION WITH PSYCHOTIC FEATURES (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.

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