Obsessive-Compulsive Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 15 or older 2. Patients diagnosed with obsessive-compulsive disorder who meet DSM-5-TR diagnostic criteria 3. Receiving treatment on an outpatient basis 4. Patients with a Y-BOCS score of 14 or higher on the screening test 5. Patients who own a smartphone (with iOS (version 12.0 or later) or Android (version 7.0 or later) and can operate it appropriately for this study
Exclusion criteria
Exclusion criteria: 1. Patients determined to have suicidal ideation 2. Patients with Alcohol or Drug Dependency 3. Patients with complications of depression or suspected tics 4. Patients with complications that make them ineligible for safety 5. Patients who have received 12 weeks of standardized CBT for obsessive-compulsive disorder 6. Patients who are not stable on psychotropic medications 7.Patients who have received TMS treatment or electroconvulsive therapy in the past 8.Pregnant women, lactating women 9.Patients who have participated in other clinical trials or clinical studies, used investigational drugs, medical devices, or regenerative medicine products, or received or will receive CBT, etc 10.Patients who are judged to be inappropriate to participate in this study by the principal investigator or a subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Y-BOCS (face-to-face) score at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change from baseline in Y-BOCS (face-to-face) score at 16 weeks 2.Change from baseline in Y-BOCS (face-to-face) score at 28 weeks 3.Improvement based on Y-BOCS (face-to-face) scores at 12, 16, and 28 weeks(Steketee et al.) 4.Improvement based on Y-BOCS (face-to-face) scores at 12, 16, and 28 weeks(Farris et al.) 5.Remission based on Y-BOCS (face-to-face) score at 12, 16, and 28 weeks(Farris et al.) 6.Change from baseline in Obsessive Compulsive Symptom Scale (OCI) score at each measurement point 7.Change from baseline in State-Trait Anxiety Scale (STAI) score at each measurement point 8.Change from baseline in the Brief Depressive Symptom Scale (QIDS-J) score at each measurement time point 9.Change from baseline in WHO QOL26 score at each measurement time point 10.Change from baseline in EuroQol 5 dimensions 5-level (EQ-5D-5L) quality of life score at each measurement point | — |
Contacts
emol inc.