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

This study is currently recruiting participants.
Verified April 2017 by Zhen Wang, Shanghai Mental Health Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02022709
First Posted: December 30, 2013
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Shanghai Municipal Science and Technology Commission
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Zhen Wang, Shanghai Mental Health Center
  Purpose
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.

Condition Intervention Phase
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Drug: Fluoxetine Drug: Sertraline Drug: Paroxetine Drug: Citalopram Drug: Fluvoxamine Behavioral: Exposure and Response Prevention Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Exposure and Response Prevention(ERP) and SSRIs, and Its Predictors in Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Zhen Wang, Shanghai Mental Health Center:

Primary Outcome Measures:
  • The change of Yale-Brown Obsessive-Compulsive Scale score [ Time Frame: from baseline to month 6 ]
    Patients were assessed at 0 week(w), 2w, 4w, 8w, 10w, 12w, 16w(0 month), 6 month


Secondary Outcome Measures:
  • The change of Beck Depression Inventory(BDI-II) score [ Time Frame: from baseline to month 6 ]
  • The change of Beck Anxiety Inventory(BAI) score [ Time Frame: from baseline to month 6 ]
  • The change of Stress Perceived Questionnaire (PSS-10) score [ Time Frame: from baseline to month 6 ]
  • The change of Behavioral Inhibition/Behavioral Activation System Scales score [ Time Frame: from baseline to month 6 ]
  • The change of Barratt Impulsiveness Scale 11 (BIS-11) score [ Time Frame: from baseline to month 6 ]
  • The change of Obsessive Beliefs Questionnaire-44(OBQ-44) score [ Time Frame: from baseline to month 6 ]
  • The NEO-Five Factor Inventory-Revised (NEO-FFI-R) [ Time Frame: at baseline ]
  • The Early Trauma Inventory Self Report-Short Form(ETISR-SF) [ Time Frame: at baseline ]

Other Outcome Measures:
  • Stop Signal Task (SST) [ Time Frame: from baseline to month 6 ]
    a measure of behavioral response inhibition

  • fMRI(Functional Magnetic Resonance Imaging) - stop signal task [ Time Frame: from baseline to month 6 ]
    a measure of behavioral response inhibition

  • C Reaction Protein(CRP) [ Time Frame: from baseline to month 6 ]
  • Complete Blood Count [ Time Frame: from baseline to month 6 ]
    for safety considerations

  • Liver and Kidney Function [ Time Frame: from baseline to month 6 ]
    for safety considerations

  • Resting State Functional Magnetic Resonance Imaging [ Time Frame: from baseline to month 6 ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Prozac
Drug: Sertraline
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Other Name: Zoloft
Drug: Paroxetine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Other Name: Seroxat
Drug: Citalopram
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Other Name: Cipramil
Drug: Fluvoxamine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Other Name: 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 Name: Exposure and Rituals 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022709


Contacts
Contact: Zhen Wang, Ph.D, M.D 862164387250 ext 73516 wangzhen@smhc.org.cn

Locations
China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Zhen Wang, Ph.D, M.D    862164387250 ext 73516    wangzhen@smhc.org.cn   
Principal Investigator: Zhen Wang, Ph.D, M.D         
Sponsors and Collaborators
Shanghai Mental Health Center
Shanghai Municipal Science and Technology Commission
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Zhen Wang, Ph.D, M.D Shanghai Mental Health Center
  More Information

Responsible Party: Zhen Wang, Director, Research and Education Department, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02022709     History of Changes
Other Study ID Numbers: 124119a8601
YG2013MS65 ( Other Grant/Funding Number: Biomedical Engineering Cross Project of Shanghai Jiao Tong University )
First Submitted: December 15, 2013
First Posted: December 30, 2013
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Zhen Wang, Shanghai Mental Health Center:
Cognitive Behavior Therapy
Exposure and Response/Ritual Prevention
Selective Serotonin Reuptake Inhibitors
Psychotherapy
Pharmacotherapy
Citalopram
Fluoxetine
Paroxetine
Sertraline
Fluvoxamine
fMRI
Stop Signal Task

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Sertraline
Paroxetine
Fluoxetine
Citalopram
Fluvoxamine
Serotonin Uptake Inhibitors
Serotonin
Dexetimide
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Receptor Agonists