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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022709
• Other study ID #: 124119a8601
• Secondary ID: YG2013MS65
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: March 13, 2018

Study information

• Verified date: September 2022
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 13, 2018
• Est. primary completion date: November 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Mental Disorders
• Obsessive-Compulsive Disorder

Intervention

Drug:
• 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.

Behavioral:
• Exposure and Response Prevention
8 exposure and response prevention (ERP) sessions,once a week

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai Jiao Tong University School of Medicine, Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stop Signal Task (SST)	a measure of behavioral response inhibition	from baseline to month 6
Other	fMRI(Functional Magnetic Resonance Imaging) - stop signal task	a measure of behavioral response inhibition	from baseline to month 6
Other	C Reaction Protein(CRP)	for safety considerations	from baseline to month 6
Other	Complete Blood Count	for safety considerations	from baseline to month 6
Other	Liver and Kidney Function	for safety considerations	from baseline to month 6
Other	Resting State Functional Magnetic Resonance Imaging	to quantify brain network	from baseline to month 6
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The NEO-Five Factor Inventory-Revised (NEO-FFI-R)	Patients were assessed at 0 week(w),	at baseline
Secondary	The Early Trauma Inventory Self Report-Short Form(ETISR-SF)	Patients were assessed at 0 week(w)	at baseline