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Obsessive-Compulsive Disorder | Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients

Obsessive-Compulsive Disorder research study

What is the primary objective of this study?

The purpose of this study is to evaluate the efficiency of SSRIs(Selective Serotonin Reuptake Inhibitor) ,ERP(Exposure and Response Prevention) and the combination of the two therapies for OCD(Obsessive-Compulsive Disorder) patients ,at the same time, to find out the biological or psychological predictors of treatment response in Chinese population.

Who is eligible to participate?

Inclusion Criteria: - Having been diagnosed with primary OCD as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-) criteria;Cleaning or checking as primary OCD symptoms - Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 16 - Never receiving adequate treatment or stop receiving treatment for at least 8 weeks - Having an education degree of high school or above - Accepting to participate in the study Exclusion Criteria: - Having significant medical illnesses that would interfere with the conduct of the study - Clinically significant abnormal laboratory finding - Having comorbid psychiatric conditions according to the criteria set forth in the DSM-IV(administered by the Mini-International Neuropsychiatric Interview (MINI)) - The current OCD symptoms are too severe that the patient cannot finish the evaluation or receive the ERP - Being currently at risk for suicide - Being pregnant or having the intention to be pregnant before the end of the study - A history of having inadequate response to adequate SSRIs or CBT treatment - Subjects who are unable to undergo the MRI

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Obsessive-Compulsive Disorder

Anxiety Disorders

Mental Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:FluoxetineThe dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Drug:SertralineThe dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Drug:ParoxetineThe dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Drug:CitalopramThe dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Drug:FluvoxamineThe dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Behavioral:Exposure and Response Prevention8 exposure and response prevention (ERP) sessions,once a week

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Selective Serotonin Reuptake InhibitorIn this group,routine treatment strategies will be used for patients. Any one of the SSRIs including fluoxetine, citalopram, paroxetine, sertraline, fluvoxamine ,which are approved in the treatment of OCD by SFDA,, may be used for patients who are randomized to this treatment arm. The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Exposure and Response PreventionExposure and Response Prevention Structured protocol described by Foa et al., 2012 Patients will attend eight 1-h sessions,once a week. Benzodiazepine will be used when necessary.

Study Status

Recruiting

Start Date: January 2014

Completed Date: December 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: The change of Yale-Brown Obsessive-Compulsive Scale score

Secondary Outcome: The change of Beck Depression Inventory(BDI-II) score

Study sponsors, principal investigator, and references

Principal Investigator: Zhen Wang, Ph.D, M.D

Lead Sponsor: Shanghai Mental Health Center

Collaborator: Shanghai Municipal Science and Technology Commission

More information:https://clinicaltrials.gov/show/NCT02022709

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