Clinical and Neural Changes of CBT in patients with Major Depression: a Randomized Clinical Trial with fMRI investigatio
Phase 2
- Conditions
- Major Depressive Disorder
- Registration Number
- JPRN-UMIN000018155
- Lead Sponsor
- Keio Imaging Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
Not provided
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BOLD signal during future thinking task recorded by fMRI
- Secondary Outcome Measures
Name Time Method -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