Major Depressive Disoder
Conditions
Interventions
Participants will be scheduled for 16 weekly sessions using CBT-VR as outpatients.
Sponsors
Hayashi Daisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects with a diagnosis of Major Depressive Disorder as defined by DSM-5 2)Subjects with HAMD-17 score >=12 at screening 3)Subjects who have not responded to at least one antidepressant treatment or subjects who are not suitable for antidepressants due to tolerability, comorbidity, pregnancy, or noncompliance of medications 4)Between 18 and 65 years of age 5)Subjects who give full consent in the participation of the study
Exclusion criteria
Exclusion criteria: 1)History or concurrent manic, hypomanic, or psychotic episode 2)History or concurrent personality disorder or PTSD 3)History or concurrent alcohol or substance use disorder 4)Serious suicidal ideation 5)Subjects who have not responded to CBT 6)Subjects who have any difficulty using the VR device and the mobile application 7)Other relevant reason decided by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HAMD-17 from baseline to session 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Adherence to treatment 2)Time of consultation for CBT therapy 3)Usability, satisfaction, and homework compliance 4)Changes in HAMD-17 from baseline to session 8 5)Changes in MADRS, QIDS-SR, EQ-5D-5L, and CGI from baseline to session 8 or 16 6)Rates of remission defined as HAMD-17<=7 or MADRS<=10 7)Rates of response defined as a reduction of 50% or more of HAMD-17 or MADRS 8)Changes in HAMD-17, MADRS, QIDS-SR, EQ-5D-5L, and CGI for the follow-up period. 9)Rates of subjects who achieve a success in reducing psychiatric medications at 3- or 6-month follow-up 10)Adverse events 11)Malfunction | — |
Contacts
Public ContactAi Ito
National Center of Neurology and Psychiatry Hospital
Outcome results
None listed