Major depressive disorder Bipolar disorder
Conditions
Interventions
none
aerobic exercise (20 min/day, twice /week, 12 weeks)
computer-based cognitive training(20 min/day, twice /week, 12 weeks)
aerobic exercise combined with computer-based cognitive training (20 min/
Sponsors
Medical Care Toranomon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Major depressive episode of major depressive disorder or bipolar disorder defined by DSM-5 2) Patients treated with fixed regimen of medication and/or psychotherapy 3) Total Beck Depression Inventory 2 score >=15 at baseline
Exclusion criteria
Exclusion criteria: 1) Patients with psychotic feature 2) Depression secondary to a general medical condition, or substance-induced 3) rapid cycling bipolar disorder 4) History of substance abuse or dependence within the past 6 months (except nicotine and caffeine) 5) Patients with contraindication for exercise therapy (ex orthopedic disease, cardiovascular disease) 6) Patients who have been exercising continuously within the past year 7) Present suicidal risk as assessed by the investigator or a tendency of attempted suicide in BDI-2 score 8)Any self-inflicted harm in the past 9)Women who are pregnant or breast-feeding 10) Patients undergoing computer-based cognitive training
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BDI-2 score at 4week, 8week and 12week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The rates of response and remission at 4week, 8week and 12week. 2)Change in MOS 36-Item Short-Form Health Survey(SF-36) at 4week, 8week and 12week. 3)Change in THINC-it score at 4week, 8week and 12week. 4) adverse events | — |
Countries
Japan
Contacts
Public ContactToshihide Hayashi
Medical Care Toranomon Medical Care Toranomon
Outcome results
None listed