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

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders; Obsessive-Compulsive Disorder; Anxiety Disorders
• Intervention / Treatment: Drug: Fluoxetine; Drug: Sertraline; Drug: Paroxetine; Drug: Citalopram; Drug: Fluvoxamine; Behavioral: Exposure and Response Prevention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stop Signal Task (SST)	a measure of behavioral response inhibition	from baseline to month 6
fMRI(Functional Magnetic Resonance Imaging) - stop signal task	a measure of behavioral response inhibition	from baseline to month 6
C Reaction Protein(CRP)	for safety considerations	from baseline to month 6
Complete Blood Count	for safety considerations	from baseline to month 6
Liver and Kidney Function	for safety considerations	from baseline to month 6
Resting State Functional Magnetic Resonance Imaging	to quantify brain network	from baseline to month 6

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Shanghai Jiao Tong University School of Medicine; Shanghai Municipal Science and Technology Commission
• Investigators: Principal Investigator: Zhen Wang, Ph.D, M.D, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 18, 2017
• Study Completion (Actual): March 13, 2018

Study Registration Dates

• First Submitted: December 15, 2013
• First Submitted That Met QC Criteria: December 21, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: fMRI; Pharmacotherapy; Psychotherapy; Sertraline; Cognitive Behavior Therapy; Fluoxetine; Citalopram; Exposure and Response/Ritual Prevention; Selective Serotonin Reuptake Inhibitors; Paroxetine; Fluvoxamine; Stop Signal Task
• Additional Relevant MeSH Terms: Pathologic Processes; Personality Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Sertraline; Citalopram; Paroxetine; Fluoxetine; Fluvoxamine
• Other Study ID Numbers: 124119a8601; YG2013MS65 (Other Grant/Funding Number: Biomedical Engineering Cross Project of SJTU)