Pragmatic Trial of Obsessive-compulsive Disorder
Recruiting · NCT04539951 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Mental Health Center
View the official record on ClinicalTrials.gov →Interventions studied
Augment with AripiprazoleAugment with MemantineFluvoxamineSertraline 200 milligram(mg)Sertraline 300 milligram(mg)Venlafaxine
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 (BDI) 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.
Where it is running
1 location listed.
- Shanghai Mental Health Center - Shanghai, Shanghai Municipality, China