Major Depressive Disorder
Conditions
Interventions
Cognitive Behavioral Therapy
Talking Control
Sponsors
Keio Imaging Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with DSM-IV Major Depressive Disorder based on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder (SCID) at screening. 2. Subjects with HAMD-17 score >=16 at screening. 3. Subjects who give full consent in the participation of the study.
Exclusion criteria
Exclusion criteria: 1. No comorbid alcohol or substance use disorder in 2 years prior to the screening. 2. No history or concurrent manic or psychotic episode. 3. No other primary DSM-IV Axis I Disorders in 6 months prior to the screening. 4. No comorbid of antisocial personality disorder. 5. No serious and imminent suicidal ideation at screening. 6. Unlikely to attend more than 8 visits during the 16-week trial phase (eg, due to relocation). 7. Have previously completed an individual CBT programme. 8. No organic brain lesions or major cognitive deficits in a year prior to the screening. 9. No severe or unstable medical illness at screening. 10. Contraindication to MRI (including cardiac pacemaker, claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BOLD signal during future thinking task recorded by fMRI | — |
Secondary
| Measure | Time frame |
|---|---|
| -Depression symptoms: GRID-Hamilton Depression Rating Scale, Beck Depression Inventory, Quick Inventory of Depressive Symptomatology -Remission: defined as HAMD-17=<7 -Response: defined as 50% reduction of baseline HAMD-17total score -Dysfunctional attitude: Dysfunctional Attitude Scale, -Automatic thoughts: Automatic Thoughts Questionnaire Revised, QOL: EuroQol -Cognitive function: Word Fluency test, Digit Symbol Substitution test | — |
Countries
Japan
Contacts
Public ContactAtsuo Nakagawa, MD, PhD
Keio University School of Medicine Center for Clinical Research
Outcome results
None listed