Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients
NCT ID: NCT02022709
Last Updated: 2022-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
78 participants
INTERVENTIONAL
2014-01-31
2018-03-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
Fluoxetine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Sertraline
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Paroxetine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Citalopram
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Fluvoxamine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
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.
Exposure and Response Prevention
8 exposure and response prevention (ERP) sessions,once a week
Interventions
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Fluoxetine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Sertraline
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Paroxetine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Citalopram
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Fluvoxamine
The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
Exposure and Response Prevention
8 exposure and response prevention (ERP) sessions,once a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
65 Years
ALL
Yes
Sponsors
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Shanghai Municipal Science and Technology Commission
OTHER_GOV
Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Mental Health Center
OTHER
Responsible Party
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Zhen Wang
Director, Research and Education Department
Principal Investigators
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Zhen Wang, Ph.D, M.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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YG2013MS65
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
124119a8601
Identifier Type: -
Identifier Source: org_study_id
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