A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, PHASE III, EFFICACY AND SAFETY STUDY OF FIXED DOSE GROUPS OF TC-5214 (S-MECAMYLAMINE) AS AN ADJUNCT O AN ANTIDEPRESSANT IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER WHO EXHIBIT AN INADEQUATE RESPONSE TO ANTIDEPRESSANT THERAPY
- Registration Number
- PER-024-11
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
1. PROVISION OF SIGNED AND DATED INFORMED CONSENT BEFORE INITIATION OF ANY STUDY-RELATED PROCEDURES.
2. PATIENTS MUST PROVIDE ACCEPTABLE PROOF OF IDENTITY DOCUMENTATION TO CONFIRM INITIALS AND DATE OF BIRTH.
3. MALE OR FEMALE PATIENTS AGED 18-65 YEARS, INCLUSIVE:
• MALE PATIENTS: MALE PATIENTS WHO ARE SEXUALLY ACTIVE MUST USE A DOUBLE BARRIER METHOD CONTRACEPTION (CONDOM WITH SPERMICIDE) FROM THE FIRST DOSE OF IP UNTIL 12 WEEKS AFTER THEIR LAST DOSE.
• WOMEN OF CHILDBEARING POTENTIAL: WOMEN OF CHILD-BEARING POTENTIAL (WOCBP) MUST HAVE A NEGATIVE URINE PREGNANCY TEST AND CONFIRMED (BY THE INVESTIGATOR) USE OF A HIGHLY EFFECTIVE FORM OF BIRTH CONTROL FOR 3 MONTHS BEFORE ENROLLMENT AND UNTIL 3 MONTHS AFTER THEIR LAST DOSE OF IP. THE FOLLOWING METHODS OF HIGHLY EFFECTIVE BIRTH CONTROL INCLUDE THE BIRTH CONTROL OPTION PLUS THE USE OF A CONDOM BY THE MALE SEXUAL PARTNER: VASECTOMIZED SEXUAL PARTNER, TUBAL OCCLUSION, INTRAUTERINE SYSTEM (eg., MIRENA), DEPO-PROVERA, IMPLANTS (IMPLANON, NORPLANT), COMBINED ORAL PILLS AND NORMAL LOW DOSE, ETHINYLESTRADIOL TRANSDERMAL SYSTEM (EVRA PATCH) AND DEVICE INTRAVAGINAL (NUVARING).
1. PATIENTS WITH: A) LIFETIME HISTORY OF BIPOLAR DISORDER AND/OR PSYCHOTIC DISORDER; MDD WITH PSYCHOTIC FEATURES IS EXCLUDED;
B) CURRENT (WITHIN 12 MONTHS BEFORE OPEN-LABEL BASELINE [VISIT 2]), MANIC EPISODE, POST TRAUMATIC STRESS DISORDER AS ASSESSED BY THE MINI 6.0 AND CONFIRMED BY THE INVESTIGATOR;
C) CURRENT (WITHIN 12 MONTHS BEFORE OPEN-LABEL BASELINE [VISIT 2]) GENERALIZED ANXIETY DISORDER, PANIC DISORDER, OBSESSIVE COMPULSIVE DISORDER OR SOCIAL ANXIETY DISORDER AS ASSESSED BY THE MINI 6.0; AND CONSIDERED BY THE INVESTIGATOR TO BE PRIMARY (CAUSING A HIGHER DEGREE OF DISTRESS OR IMPAIRMENT THAN MDD).
2. PATIENTS WITH A DIAGNOSIS OF DSM-IV-TR AXIS II DISORDER WHICH HAS A MAJOR IMPACT ON THE PATIENT´S CURRENT PSYCHIATRIC STATUS.
3. PATIENTS WHOSE CURRENT EPISODE OF DEPRESSION STARTED LESS THAN 8 WEEKS BEFORE SCREENING.
4. HISTORY OF HYPERSENSITIVITY OR INTOLERANCE TO DRUGS WITH A SIMILAR CHEMICAL STRUCTURE OR CLASS TO TC-5214.
5. SUBSTANCE OR ALCOHOL ABUSE OR DEPENDENCE WITHIN 6 MONTHS PRIOR TO ENROLLMENT (EXCEPT DEPENDENCE IN FULL REMISSION, AND FOR CAFFEINE OR NICOTINE DEPENDENCE), AS DEFINED IN DSM-IV-TR CRITERIA.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method