Major depressive disorder
Conditions
Interventions
Combination of smartphone-based cognitive behavioral therapy and pharmacotherapy
pharmacotherapy alone
Sponsors
Fujita Health University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have provided written informed consent after receiving sufficient explanation about the study and fully understanding it, based on their own free will Adult patients (aged 18 years or older) with depression who did not achieve the expected therapeutic effect despite adequate pharmacotherapy with existing antidepressants and were judged to be eligible for rTMS therapy Patients who, after 3 to 6 weeks of rTMS therapy, demonstrated response, defined as a reduction of 50% or more in HAMD-17 total score from baseline, or remission, defined as a HAMD-17 total score of 7 or lower, and with a PHQ-9 score of less than 10 Patients capable of verbal and written communication in Japanese Patients who own a smartphone and are familiar with its operation
Exclusion criteria
Exclusion criteria: Patients with suicidal ideation Patients with a history of schizophrenia, schizoaffective disorder, or bipolar disorder, as clinically diagnosed by the attending physician Patients with a current diagnosis of dementia, eating disorder, substance dependence, or borderline personality disorder, as clinically diagnosed by the attending physician Patients judged by the investigators to have difficulty using the smartphone application Any other patients deemed inappropriate for participation by the principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival up to 26 weeks from study initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in PHQ-9 GAD-7 and EQ-5D-5L scores Incidence of major depressive episodes as assessed by CIDI Occurrence of PHQ9 total score greater than or equal to 10 with endorsement of item 9 (Thoughts that you would be better off dead or of hurting yourself in some way) at level 2 (more than half the days) or level 3 (nearly every day) on two consecutive assessments Hospitalization and death Adverse events spontaneously reported by study participants | — |
Countries
Japan
Contacts
Public ContactYuki Matsuda
Fujita Health University School of Medicine Department of Development and Education of Clinical Research
Outcome results
None listed