Pragmatic Trial of Obsessive-compulsive Disorder

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study includes a sequenced clinical trial in order to assess the efficacy of several switching or augment strategies when initial treatment is ineffective，and to provide strong evidence for clinical practice and international guidelines for Obsessive-Compulsive Disorder treatments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Collaborators: First Affiliated Hospital of Jinan University; General Hospital of Ningxia Medical University; Guizhou Provincial People's Hospital; Hangzhou Seventh People's Hospital; Henan Mental Hospital; Nanjing Medical University; Seventh People's Hospital of Hangzhou; Suzhou Psychiatric Hospital; The First Affiliated Hospital of Kunming Medical College; The First Affiliated Hospital of Nanchang University; The first specialized hospital of harbin; The Second Affiliated Hospital of Xinxiang Medical University; West China Hospital; Wuhan Mental Health Centre
• Treatments: Aripiprazole; Fluvoxamine; Memantine; Sertraline; Venlafaxine Hydrochloride

Criteria

Inclusion criteria:They

• meet DSM-5 diagnostic criteria for OCD as the primary diagnosis ;

• are in the age range from 18 to 65 years;

• have a score of at least 20 on Yale-Brown Obsessive-Compulsive Scale (Y-BOCS);

• have never received medication for OCD, and have not received any form of psychotherapy for OCD in the past 1 month;

• have provided written informed consent.

exclusion criteria: They

• have met the DSM-5 diagnostic criteria for Schizophrenia Spectrum and Other Psychotic Disorders, or the Bipolar and Related Disorders;

• have a moderate or higher risk of suicide (⩾9 on the Suicide Module in the Mini-International Neuropsychiatric Interview (MINI));

• have substance use that is sufficiently severe to possibly impact negatively on treatment adherence in the past 1 year;

• have severe depression with Beck Depression Inventory-II (BDI-II) score of ≥29;

• have comorbid psychiatric or medical disorders that may impact negatively on adherence to or on the efficacy of medication (eg borderline personality disorder, CNS disorders)；

• are pregnant or lactating females.