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Pragmatic Trial of Obsessive-compulsive Disorder

RECRUITINGPhase 2Sponsored by Shanghai Mental Health Center
Actively Recruiting
PhasePhase 2
SponsorShanghai Mental Health Center
Started2020-09-22
Est. completion2027-06-30
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04539951

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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.

Conditions2

AnxietyObsessive-compulsive Disorder

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