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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Shanghai Mental Health Center
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT02022709
First received: December 15, 2013
Last updated: January 6, 2014
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 Shanghai Mental Health Center:

Primary Outcome Measures:
  • The change of Yale-Brown Obsessive-Compulsive Scale score [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • The change of Beck Anxiety Inventory(BAI) score [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
  • The change of Stress Perceived Questionnaire (PSS-10) score [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
  • The change of Behavioral Inhibition/Behavioral Activation System Scales score [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
  • The change of Barratt Impulsiveness Scale 11 (BIS-11) score [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
  • The change of Obsessive Beliefs Questionnaire-44(OBQ-44) score [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
  • The NEO-Five Factor Inventory-Revised (NEO-FFI-R) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • The Early Trauma Inventory Self Report-Short Form(ETISR-SF) [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Stop Signal Task (SST) [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
    a measure of behavioral response inhibition

  • fMRI(Functional Magnetic Resonance Imaging) - stop signal task [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
    a measure of behavioral response inhibition

  • C Reaction Protein(CRP) [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]
  • Complete Blood Count [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: Yes ]
    for safety considerations

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

  • Resting State Functional Magnetic Resonance Imaging [ Time Frame: from baseline to month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: February 2016 (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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 15, 2013
Last Updated: January 6, 2014
Health Authority: China: Ethics Committee

Keywords provided by 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 and Disorders with Psychotic Features
Anxiety Disorders
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Personality Disorders
Citalopram
Fluoxetine
Paroxetine
Fluvoxamine
Sertraline
Serotonin Uptake Inhibitors
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014