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

NCT02022709 | Completed Phase 4

• 2 other identifiers: 124119a8601YG2013MS65
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders

Keywords

Cognitive Behavior Therapy; Exposure and Response/Ritual Prevention; Selective Serotonin Reuptake Inhibitors; Psychotherapy; Pharmacotherapy; Citalopram; Fluoxetine; Paroxetine; Sertraline; Fluvoxamine; fMRI; Stop Signal Task

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The change of Beck Depression Inventory(BDI) score

  from baseline to month 6

• The change of Beck Anxiety Inventory(BAI) score

  from baseline to month 6

• The change of Stress Perceived Questionnaire (PSS-10) score

  from baseline to month 6

• The change of Behavioral Inhibition/Behavioral Activation System Scales score

  from baseline to month 6

• The change of Barratt Impulsiveness Scale 11 (BIS-11) score

  from baseline to month 6

Other Outcomes (6)

• Stop Signal Task (SST)

  from baseline to month 6

• fMRI(Functional Magnetic Resonance Imaging) - stop signal task

  from baseline to month 6

• C Reaction Protein(CRP)

  from baseline to month 6

Study Arms (2)

Selective Serotonin Reuptake Inhibitor

ACTIVE COMPARATOR

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; Drug: Sertraline; Drug: Paroxetine; Drug: Citalopram; Drug: Fluvoxamine

Exposure and Response Prevention

ACTIVE COMPARATOR

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

Interventions

Fluoxetine DRUG

The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Also known as: Prozac

Selective Serotonin Reuptake Inhibitor

Sertraline DRUG

The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Also known as: Zoloft

Selective Serotonin Reuptake Inhibitor

Paroxetine DRUG

The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Also known as: Seroxat

Selective Serotonin Reuptake Inhibitor

Citalopram DRUG

The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Also known as: Cipramil

Selective Serotonin Reuptake Inhibitor

Fluvoxamine DRUG

The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.

Also known as: Luvox

Selective Serotonin Reuptake Inhibitor

Exposure and Response Prevention BEHAVIORAL

8 exposure and response prevention (ERP) sessions,once a week

Also known as: Exposure and Rituals Prevention

Exposure and Response Prevention

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Shanghai Municipal Science and Technology Commission: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders

Interventions

Fluoxetine; Sertraline; Paroxetine; Citalopram; Dexetimide; Fluvoxamine

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidones; Oximes; Hydroxylamines

Study Officials

• Zhen Wang, Ph.D, M.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research and Education Department

Study Record Dates

• First Submitted: December 15, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2014
• Primary Completion: November 18, 2017
• Study Completion: March 13, 2018
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

CN (1)