Major Depressive Disorder
Conditions
Interventions
internet-assisted cognitive behavior therapy in addition to treatment as usual
treatment as usual
Sponsors
i-CBT study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with current DSM-IV Major Depressive Disorder based on SCID at screening. 2.Subjects with HAMD-17 score>=14 at screening. 3.Subjects who had received at least adequate one trial of antidepressant therapy for more than 6weeks. 4.Aged 20 years or older, and younger than 65 years at screening. 5.Subjects who give full consent in the participation of the study. 6.Subjects who can be used to use the internet. 7.Subjects who have the possibility that they can go to the hospital more than 6 times during the study period.
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.No past treatment of individual CBT. 7.No organic brain lesions or major cognitive deficits in a year prior to the screening. 8.No severe or unstable medical co-morbidities at screening. 9.Other relevant reason decided by the i-CBT principal investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Response rate(defined as 50% reduction of baseline HAMD-17),remission rate(defined as HAMD=<7),subjective depression(measured with the BDI and QIDS),quality of life(measured with EQ-5D and SF-36) and vulnerability measure of depression and cognition (DAS) at 12week and post-intervention phase(up to 6months) will be compared between the groups.Cost effectiveness (ICER per remitted patient and ICER per QALY) will be also compared between the groups. | — |
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD-17) score at endpoint will be compared between the groups | — |
Countries
Japan
Contacts
Public ContactYoshiyo Oguchi
National Center of Neurology & Psychiatry CBT Center
Outcome results
None listed