Treatment-resistant Depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) having a diagnosis of DSM-IV Major Depressive Disorder confirmed with the SCID 2) have been treated with antidepressants or cognitive behavioral therapy for depression at least 8 weeks up to screening. 3) GRID-HAMD-17>=14 4) can attend session more than 8 5) 20 years old <= age <70 years old 6) can obtain written consent
Exclusion criteria
Exclusion criteria: 1) No alcohol or substance use disorder in 12 months prior to the screening 2) No history or concurrent manic episode or psychotic disorders 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) No organic brain lesions or major cognitive deficits in a year prior to the screening 7) No severe or unstable medical co-morbidities at screening 8) No structured psychotherapy during the intervention. 9) Other relevant reason decided by the CBT principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 16wk 2. Drop-out rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 28 and 40wk 2. Beck Depression Inventory (BDI-II), Generalized Anxiety Disorder (GAD-7), Ruminative Responses Scale (RRS), Sheehan Disability Scale (SDISS), Cognitive-Behavioral Avoidance Scale (CBAS), Coping Inventory for Stressful Situations (CISS): 0,8,16,28,40 wks 3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session 4. Client satisfaction questionnaire (CSQ-8j): 0, 8,16 wks | — |
Countries
Japan
Contacts
Keio University School of Medicine Department of Neuropsychiatry