Patients with Major Depressive Disorder
Conditions
Sponsors
Takeda Global Research & Development Center, Inc.,*
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject suffers from major depressive disorder (MDD) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x). 2. The reported duration of the current major depressive episode is at least 3 months at the Screening Visit. 3. The subject has a MADRS total score =>26 at the Screening and Baseline Visits. 4. The subject has a clinical global impression scale-severity (CGI-S) score =>4 at the Screening and Baseline Visits.
Exclusion criteria
Exclusion criteria: 1. The subject has one or more of the following conditions: - Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (assessed by the Mini International Neuropsychiatric Interview: MINI). A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR. - 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 as defined in the DSM-IV-TR. - Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. Subject with confirmed positive urine drug screens (except prescribed medication or a medication that does not constitute drug abuse)will be excluded. - Presence or history of a clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder. (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.) - Any DSM-IV-TR axis II disorder that might compromise the study. 2. The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. 3. The subject has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit. 4. The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study. 5. The subject is at significant risk of suicide or has a score =>5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. 8 weeks MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms rated on a 7-point Likert scale from 0 to 6 with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS response at Week 8, with response defined as a =>50% decrease in the MADRS total score from Baseline. 8 weeks MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms rated on a 7-point Likert scale from 0 to 6 with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS remission at Week 8, with remission defined as a MADRS total score =<10. 8 weeks MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms rated on a 7-point Likert scale from 0 to 6 with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. Clinical Global Impression Scale - Improvement (CGI-I) score at Week 8. 8 weeks The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement compared to his condition at the start of the study, which is rated on a seven-point scale (1=very much improved to 7=very much worse). Higher scores indicate greater severity of illness. Change from Baseline in Sheehan Disability Scale (SDS) total score at Week 8. 8 weeks The Sheehan Disability Scale is a 3 item rating scale to assess functional impairment over three inter-related domains (work/school, social life, and family life/home responsibilities). A subject self-rates on a 0-10 point visual analog scale from 0 to 10 with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. | — |
Outcome results
None listed