Major Depressive Disorder
Conditions
Interventions
Sponsors
CREC Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with current DSM-4 Major Depressive Disorder based on SCID-P at screening 2.Subjects with HAMD-17 score>16 at screening 3.Aged 20 years or older, and 65 years or younger at screening 4.Subjects who give full consent in the participation of the study
Exclusion criteria
Exclusion criteria: 1.No alcohol or substance use disorder in 6 months prior to the screening. 2.No history or concurrent manic or psychiatric episode. 3.No other primary DSM-4 Axis1 Disorders at screening. 4.No comorbid of antisocial personality. 5.No serious suicidal ideation at screening. 6.Evidence of unable to participate half or more of the intervention phase. 7.No past treatment of CBT. 8.No organic brain lesions or major cognitive deficits in a year prior to the screening. 9.No sever or unstable medical co-morbidities at screening. 10.Other relevant reason decided by the CREC investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale(GRID-HAMD-17) score at 16 week from the baseline will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate (defined as GRID-HAMD-17<7; QIDS<5), response rate (defined as 50% reduction of baseline HAMD-17 and QIDS), subjective depression (measured with the BDI and QIDS), Quality of life (measured with EQ-5D and SF-36) score at 16 week from the baseline will be compared. Dropout rate and adverse events will also be evaluated. | — |
Countries
Japan
Contacts
Public ContactNoriko Tamura
National Center for Neurology and Psychiatry National Center for Cognitive Behavior Therapy and Research
Outcome results
None listed