Randomised, Double-blind, parallel-group, active-comparator, fixed-dose study of LuAA21004 in Major Depressive Disorder in Asian countries
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0000432
- Lead Sponsor
- undbeck Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 410
Diagnosis and Main Inclusion Criteria
- The patient suffers from recurrent Major Depressive Disorder as the primary diagnosis according to DSM-IVTR ™ criteria (classification code 296.3x). The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
- The patient has a MADRS total score =26
- The patient has a CGI-S score =4
- The reported duration of the current MDE is =3 months
- The patient is a man or woman, aged = 18 and =65 years
[Country-specific substantial protocol amendment SCA01 for Korea: The patient is a man or woman, aged > 18 and = 65 years.]
Main Exclusion Criteria
- The patient has any current anxiety psychiatric disorder (DSM-IV-TR™ criteria), as assessed using the MINI
- The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental
disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria)
- The patient has a diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine)(DSM-IV-TR™ criteria) that has not been in sustained full remission at least 2 years prior to the Screening Visit
- The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance
- The patient has a significant risk of suicide according to the investigator’s opinion or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months
- The current depressive symptoms of the patient are considered by the investigator to have been resistant to two adequate antidepressant treatments of at least 6 weeks duration each, at the recommended dose
- The patient has a history of lack of response to previous adequate treatment with venlafaxine (including current episode)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Montgomery and Asberg Depression Rating Scale
- Secondary Outcome Measures
Name Time Method Montgomery and Asberg Depression Rating Scale;Clinical Global Impression-Severity of Illness;Clinical Global Impression-Global Improvement;Mamilton Anxiety Rating Scale ;Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form;Health Economics Assessment;Sheehan Disability Scale