Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Although Selective Serotonin Reuptake Inhibitors(SSRIs) and Cognitive Behavior Therapy (CBT) including Exposure and Response Prevention(ERP) are two kinds of the first line treatments for OCD(Obsessive-Compulsive Disorder) according to APA（American Psychological Association）guideline. Both of the treatments are effective, but few research has been done to find out who are more responsive to one treatment than the other. The aim of our research is to evaluate the efficiency of SSRIs ,ERP and the combination of the two therapies for OCD patients ,at the same time, to find out the biological and psychological predictors of treatment response in Chinese population. This is a randomized, single-blind, cross-over design study.Approximately 60 patients will be randomized to SSRIs or ERP group. Neuropsychological assessment and fMRI(Functional Magnetic Resonance Imaging） will be performed at baseline,during the treatment and at the end of the study. The research has two period. In the first period(before week 8) ,the patients will have monotherapy. In the second period(after week 8), rates of improvement based on the YBOCS(Yale-Brown Obsessive Compulsive Scale) scores will be assessed. The patient will be considered responsive to treatment when he or she has a reduction in YBOCS score ≥ 35% of the score at the baseline.If the patient is responsive to the treatment that he or she has received at the first 8 weeks,he or she will continue to follow the previous treatment strategy.If not,the patient will have a combination of SSRIs and ERP treatment for another 8 weeks. The follow-up period will last up to 6 months.The result of the study will improve our knowledge about the efficacy of the two first line treatments .Also,it will help us to find out the predictors of the outcome of the two different kinds of treatments.Strategy of clinical treatment of OCD will be more individualized in the future.

Official Title
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Efficacy of Exposure and Response Prevention（ERP） and SSRIs, and Its Predictors in Obsessive-Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder, Anxiety Disorders, Mental Disorders

Intervention / Treatment
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* Drug: Fluoxetine
* Drug: Sertraline
* Drug: Paroxetine
* Drug: Citalopram
* Drug: Fluvoxamine
* Behavioral: Exposure and Response Prevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selective Serotonin Reuptake Inhibitor<br>In 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. | Drug: Fluoxetine<br>* The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.<br>* Other names: Prozac;Drug: Sertraline<br>* The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.<br>* Other names: Zoloft;Drug: Paroxetine<br>* The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.<br>* Other names: Seroxat;Drug: Citalopram<br>* The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.<br>* Other names: Cipramil;Drug: Fluvoxamine<br>* The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.<br>* Other names: Luvox;|
| Active Comparator: Exposure and Response Prevention<br>Exposure 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. | Behavioral: Exposure and Response Prevention<br>* 8 exposure and response prevention (ERP) sessions,once a week<br>* Other names: Exposure and Rituals Prevention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Yale-Brown Obsessive-Compulsive Scale score | Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month | from baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Beck Depression Inventory(BDI) score | Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month | from baseline to month 6 | 
| The change of Beck Anxiety Inventory(BAI) score | Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month | from baseline to month 6 | 
| The change of Stress Perceived Questionnaire (PSS-10) score | Patients were assessed at 0 week(w),16w(0 month), 6 month | from baseline to month 6 | 
| The change of Behavioral Inhibition/Behavioral Activation System Scales score | Patients were assessed at 0 week(w), 16w(0 month), 6 month | from baseline to month 6 | 
| The change of Barratt Impulsiveness Scale 11 (BIS-11) score | Patients were assessed at 0 week(w), 16w(0 month), 6 month | from baseline to month 6 | 
| The change of Obsessive Beliefs Questionnaire-44(OBQ-44) score | Patients were assessed at 0 week(w), 16w(0 month), 6 month | from baseline to month 6 | 
| The NEO-Five Factor Inventory-Revised (NEO-FFI-R) | Patients were assessed at 0 week(w), | at baseline | 
| The Early Trauma Inventory Self Report-Short Form(ETISR-SF) | Patients were assessed at 0 week(w) | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Citalopram, Cognitive Behavior Therapy, Exposure and Response/Ritual Prevention, Selective Serotonin Reuptake Inhibitors, Psychotherapy, Pharmacotherapy, Fluoxetine, Paroxetine, Sertraline, Fluvoxamine, fMRI, Stop Signal Task