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Obsessive-Compulsive DisorderPhase 4NCT02022709

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

A Phase 4 study testing Fluoxetine, Sertraline and Paroxetine in people with Obsessive-Compulsive Disorder and Anxiety Disorders, run by Shanghai Mental Health Center at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 16 to 65 yearsHealthy volunteers can take part
What is being tested?
Fluoxetine, Sertraline and Paroxetine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
Jan 2014to 13 Mar 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Fluoxetine, Sertraline, Paroxetine, Citalopram, Fluvoxamine
Keywords
Cognitive Behavior Therapy, Exposure and Response/Ritual Prevention, Selective Serotonin Reuptake Inhibitors, Psychotherapy, Pharmacotherapy, Citalopram, Fluoxetine, Paroxetine, Sertraline, Fluvoxamine, fMRI, Stop Signal Task
Medical subject headings
Obsessive-Compulsive Disorder, Anxiety Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluoxetineDrug

    Also called Prozac

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

  • SertralineDrug

    Also called Zoloft

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

  • ParoxetineDrug

    Also called Seroxat

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

  • CitalopramDrug

    Also called Cipramil

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

  • FluvoxamineDrug

    Also called Luvox

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

  • Exposure and Response PreventionBehavioural

    Also called Exposure and Rituals Prevention

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

Study groups in NCT02022709
Study groupRoleWhat they receive
Selective Serotonin Reuptake InhibitorActive comparatorIn 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.
Receives: Drug: Fluoxetine; Drug: Sertraline; Drug: Paroxetine; Drug: Citalopram; Drug: Fluvoxamine
Exposure and Response PreventionActive comparatorExposure 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.
Receives: Behavioral: Exposure and Response Prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from baseline to month 6

Secondary outcomes (8)

  1. 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

    Measured: from baseline to month 6

  2. 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

    Measured: from baseline to month 6

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

    Patients were assessed at 0 week(w),16w(0 month), 6 month

    Measured: from baseline to month 6

  4. The change of Behavioral Inhibition/Behavioral Activation System Scales score

    Patients were assessed at 0 week(w), 16w(0 month), 6 month

    Measured: from baseline to month 6

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

    Patients were assessed at 0 week(w), 16w(0 month), 6 month

    Measured: from baseline to month 6

  6. The change of Obsessive Beliefs Questionnaire-44(OBQ-44) score

    Patients were assessed at 0 week(w), 16w(0 month), 6 month

    Measured: from baseline to month 6

  7. The NEO-Five Factor Inventory-Revised (NEO-FFI-R)

    Patients were assessed at 0 week(w),

    Measured: at baseline

  8. The Early Trauma Inventory Self Report-Short Form(ETISR-SF)

    Patients were assessed at 0 week(w)

    Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completion18 Nov 2017
  4. Study completion13 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022709
Sponsor's protocol ID
124119a8601
Other IDs
YG2013MS65
Status last verified
Sep 2022
First submitted
15 Dec 2013
Last updated
9 Sep 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluoxetine, Sertraline and Paroxetine in people with Obsessive-Compulsive Disorder and Anxiety Disorders, run by Shanghai Mental Health Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of Yale-Brown Obsessive-Compulsive Scale score (time frame: from baseline to month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.

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