Major depressive disorder
Conditions
Interventions
smartphone cognitive-behavior therapy in addition to switch to escitalopram 5-10 mg/day or sertraline 25-100 mg/day
Switch to escitalopram 5-10 mg/day or sertraline 25-100 mg/day
Sponsors
Japan Foundation of Neuroscience and Mental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age between 25 and 59, of both sexes 2) Primary diagnosis is major depressive disorder (DSM-5) 3) Pharmacotherapy-resistant, as confirmed by no to partial response to one or more antidepressants at adequate dose for four or more weeks and scoring 10 or more on BDI-II 4) Antidepressant as monotherapy with no concomitant antipsychotic or mood stabilizer 5) Indication for smartphone CBT according to treating physician 6) Adequate knowledge of smartphone 7) Outpatient at enrollment
Exclusion criteria
Exclusion criteria: 1) Treatment with monoamine oxidase inhibitors, electroconvulsive therapy , repetitive transcranial magnetic stimulation, escitalopram/sertraline or individual face-to-face cognitive-behavior or interpersonal therapy during the index episode 2) Psychiatric omorbidities 2-1) Lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder 2-2) Current diagnosis of neurocognitive disorder, eating disorder, substance dependence or borderline personality disorder 3) Imminent risk of suicide 4) Physical comorbidities that interfere with escitalopram treatment 4-1) prolonged QTc (>450 ms for men, and >470 for women) 4-2) co-administration of drugs known to cause QTc prolongation as judged by treating physician 5) Pregnant or breast-feeding women 6) Current participation in another clinical intervention research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Slope of Patient Health Questionnaire-9 (PHQ-9) scores at 0, 1, 5 and 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Slope of Beck Depression Inventory-II (BDI-II) scores at 0, 1, 5 and 9 weeks, Response rate at 9 weeks (defined as 4 or less on PHQ-9) Treatment satisfaction at 9 weeks Continuation of antidepressant pharmacotherapy through 9 weeks Slope of Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scores at 0, 1, 5 and 9 weeks | — |
Countries
Japan
Contacts
Public ContactToshiaki A. Furukawa
Kyoto University Graduate School of Medicine / School of Public Health Dept of Health Promotion and Human Behavior
Outcome results
None listed