Pragmatic Trial of Obsessive-compulsive Disorder
A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD
Shanghai Mental Health Center
1,600 participants
Sep 22, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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.
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Interventions
All included participants will receive sertraline, initially at 50mg/d, with a weekly 50mg/d further increase, to the maximum recommended dosage (200mg/d) or to the maximum tolerated dosage (less than 200mg/d). Patients will be on their maximum dose by week 4, so allowing an assessment of response at 12 weeks
In experimental phase II, the patients in this group will remain on sertraline (higher dosage): where sertraline 200mg has been tolerated, dosage will be increased by 50mg fortnightly to a maximal dose of 300mg/d or to the maximum tolerable dose (less than 300mg/d).
Fluvoxamine will be initiated at a dose of 50mg/d, increasing quickly to a maximal dose of 300mg/d or the maximum tolerated dose by week 4.
venlafaxine will be initiated at 75mg/d, increasingly weekly by 75mg/day, to a maximal dose of 300 mg/d or the maximum tolerated dose.
Sertraline will be augmented with memantine initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d (10mg twice daily) or the maximum tolerated dose
Sertraline will be augmented with aripiprazole, initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d or the maximum tolerated dose
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04539951