Obsessive-Compulsive Disorder
Conditions
Interventions
Patients will receive istradefylline 20 mg once daily for 12 weeks. The dose can be increased to 40 mg at week 6 if clinical response is inadequate.
Sponsors
Murai Toshiya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 18 to 75 years at the time of consent. 2) Patients who can provide written consent for voluntary participation in the research. 3) Patients diagnosed with obsessive-compulsive disorder (OCD) according to the Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV). 4) Patients with a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 16 or higher at the time of research participation. 5) Patients who have shown insufficient response despite being treated with one or more antidepressant medications at adequate doses for 8 weeks or longer for obsessive-compulsive disorder.
Exclusion criteria
Exclusion criteria: 1) Patients with severe *liver disorders, kidney disorders, heart disease, lung disease, blood disorders, metabolic diseases, etc. *Refer to Grade 3 of "Standards for Classification of Severity of Adverse Drug Reactions" (Pharmaceutical Safety Notice No. 80, June 29, 1992). 2) Patients who are determined by the clinical research principal (co-) investigator to have complications or a medical history diagnosed with diseases classified as follows in DSM-5: - Schizophrenia spectrum and other psychotic disorders - Bipolar and related disorders - Substance-related and addictive disorders - Neurocognitive disorders 3) Patients with a history of hypersensitivity to istradefylline 4) Pregnant patients or those who may be pregnant, or breastfeeding female patients 5) Patients with severe liver impairment 6) Patients with ischemic heart disease 7) Patients with QTc (Fridericia correction) exceeding 450 msec 8) Patients with dyskinesia 9) Patients with clinically significant findings in medical examination, clinical tests, and 12-lead electrocardiogram 10) Patients who are otherwise difficult to complete the clinical research, patients who may suffer disadvantages by participating in the clinical research, patients whose safety cannot be ensured during the clinical research period, patients inappropriate for evaluation of efficacy or safety of drugs used in the clinical research, or patients deemed inappropriate for participation in this clinical research by the clinical research principal (co-) investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints: Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), WHODAS 2.0 (12-items), WHO Quality of Life-26 (WHOQOL-26), Two-Step Sequential Decision-Making Task Safety Endpoints: Vital Signs (body temperature, blood pressure, heart rate, respiratory rate), Electrocardiogram (ECG), Clinical Laboratory Tests, Adverse Events Pharmacokinetic Endpoint: Plasma Concentration of Istradefylline | — |
Contacts
Public ContactHirotsugu Kawashima
Kyoto University Hospital
Outcome results
None listed