Major Depressive Disorder
Conditions
Interventions
16 weeks of cognitive behavior therapy in addition to treatment as usual
16 weeks of treatment as usual alone
Sponsors
The E-CAM Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with current DSM-IV Major Depressive Disorder based on SCID-P at screening. 2. Subjects with HAMD-17 score >=16 at screening. 3. Subjects who had received 8 weeks or longer usual depression treatment for current depression episode at baseline. 4. Subjects with mild to moderate treatment resistance assessed at baseline (Mausdley Staging Method>=3). 5. Aged 20 years or older, and 65 years or younger at screening. 6. 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 psychotic episode. 3.No other primary DSM-IV Axis I Disorders at screening. 4.No comorbid of antisocial personality disorder. 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 severe or unstable medical co-morbidities at screening. 10.Other relevant reason decided by the E-CAM investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD-17) change score at 16 week from the baseline will be compared between the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (defined as 50% reduction of baseline HAMD-17), remission rate (defined as HAMD-17=<7), subjective depression (measured with the BDI and QIDS/IDS) and quality of life (measured with EQ-5D and SF-36) at 16 week and post-intervention phase (up to 12months) will be compared between the groups. Cost effectiveness (ICER per remitted patient and ICER per QALY) will be also compared between the groups. | — |
Countries
Japan
Contacts
Public ContactAtsuo Nakagawa, M.D.,Ph.D.
Keio University School of Medicine Department of Psychiatry
Outcome results
None listed