NCT02022709

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Obsessive-Compulsive Disorder
• Anxiety Disorders
• Mental Disorders

Interventions

Type	Name	Description
DRUG	Fluoxetine	The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
DRUG	Sertraline	The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
DRUG	Paroxetine	The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
DRUG	Citalopram	The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
DRUG	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

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-11-18
• Completion: 2018-03-13
• First posted: 2013-12-30
• Last updated: 2022-09-09

Locations

1 site across 1 country: China