None listed
Conditions
Interventions
PATIENTS WILL BE EVALUATED FOR ELIGIBILITY CRITERIA TWICE: FIRST AT THE SCREENING VISIT (VISIT 1) AND A SECOND TIME AT THE RANDOMIZATION VISIT (VISIT 6).
TO BE ENROLLED IN THE STUDY 8 WEEKS OF INIT
20 IN THE HAMD-17 SCALE ASSESSED BY A CLICAL PHYSICIAN AND A SCORE OF ≤
4 IN THE CGI-S SCALE. FURTHERMORE, THERE MUST NOT BE AN INADEQUATE RESPONSE IN THE PROSPECTIVE PERIOD BEFORE BE ENROLLED, IN THE ACTUAL EPISODE, TO MORE THAN ONE PREVIOUS TREATMENT WITH ANTIDEPRESSANT
6 WEEKS IN THE EFFECTIVE DOSES [AS FOR PRESCRIPTION INFORMATION]
THIS IS EVALUATED BY REVIEWING PATIENT´S HISTORY (FORM OF TREATMENT ANTECEDENTS WITH ANTIDEPRESSANTS [ATHF]).
DURING THE OPEN PERIOD ANS ADT PROSPECTIVE, THIS SUBJECTS WILL RECEIVE A OPEN THERAPY W
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Croatia, France, Germany, Hungary, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed