Depressive Disorder
Conditions
Interventions
Pre-treatment group (MBC):Pre-treatment: measurement based care (MBC)
group of Exercise therapy:Exercise therapy
group of CCBT:Computerized cognitive behavioral therapy
TAU:Anti-depressants
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients aged at least 18 years and not more than 65 years; 2. Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria(comfimed by MINI); 3. Systemic anti-depressants treatment were not adopted during current episode, or has taken anti-depressants less than 7 days in last 14 days; 4. Total scord of QIDS-SR16 >= 11 and HAMD-17 >= 20 at enrolment in open-label preliminary phase 5. Has at least primary school education and can understand the scales; 6. Prepareing to use escitalopram or duloxetine; 7. Signed an informed consent form by patients.
Exclusion criteria
Exclusion criteria: 1. History of manic episode hypomanic episode; 2. History of bipolar, schizophrenia, schizoaffective disorder, or other psychotic disorders; 3. History of drug and alcohol dependence or acute intoxication; 4. Women in pregnancy or lactation; 5. Significant risk of suicidal behaviors, HAMD-17 Item 3(suicide) score >= 3; 6. Current clinically significant disease; 7. Can not tolerate or lack of response to escitalopram or duloxetine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with complete remission in both MBC group and TAU group at endpoint of acute-phase(week 12) with QIDS-SR16<=5.;Outcome of main events in each group with different interventions (MBC or TAU), particularly recurrence rate.;resting state functional magnetic resonance imaging, rs-fMRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in QIDS-SR16, PHQ-9 and HAMD-17 scores in both MBC group and TAU group from enrollment to endpoint of acute-phase (week 12).;Response rate and remission rate in both MBC group and TAU group at week 12.;Recurrence rate, Recurrence time at endpoint of maintenance-phase.;Outcome of Mood switch/hospitalization/Suicidal behaviors or self-injurious behaviors.;The incidence of overall adverse events and severity of adverse. The incidence and nature of drug-related adverse events. Drop-off rate due to adverse events.;Continuous treatment time. actual visit times/planned visit times;assessment of social function: total score of SDS, FBS and Q-LES-Q-SF.;Acceptability, compliance and feasibility of MBC modality;Treatment compliance, Follow-up compliance;behavioral indicators; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed