Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder

July 6, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Randomized Controlled Trial of Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder

To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole, and to observe the indicators of improving patients' cognitive function and adverse drug reactions, so as to provide evidence-based evidence for supplementing the treatment guidelines for obsessive-compulsive disorder

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zheng Lin, Doctor
  • Phone Number: 13757118261
  • Email: linzzr@126.com

Study Locations

  • China
    • Zhejiang
      • Yiwu, Zhejiang, China
        • Recruiting
        • The Fourth Affiliated Hospital of Zhejiang University Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The Diagnostic criteria of OCD in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V), as well as the definition of refractory OCD, are as follows: failure to respond to oral treatment with at least two effective doses of antidepressants, including: Fluoxetine (≥20mg/ d), fluvoxamine (≥200mg/d), sertraline (≥150mg/d), and paroxetine (≥ 40mg/d) were all treated for at least 12 weeks. The Yale-Brown compulsive scale (Y-BOCS) score decreased by < 35%.
  • The total score of Yale- Brown compulsion scale (Y-BOCS) ≥16 points. (3)age 12 ~ 45 years.

Exclusion Criteria:

  • Exclusion of severe organic brain disease;
  • Severe physical illness;
  • Other mental disorders such as tics, disruptive disorders, eating disorders and autism spectrum disorders;
  • Pediatric streptococcal infection causedby autoimmune neuropsychiatric disease (PANDAS);
  • Alcohol and drug dependence; Angle-closure glaucoma;
  • Suicidal tendencies;
  • Previous history of drug allergies related to research;
  • Pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sertraline combined with fluvoxamine
Sertraline combined with fluvoxamine treatment group: Gradually add the drug to the treatment dose, and monitor the symptom change, scale score, blood drug concentration and other indicators
Drug: sertraline fluvoxamine
the initial dose of sertraline was given 50mg/d and the initial dose of fluvoxamine was 50mg/d, and the target dose of sertraline was gradually increased to 200mg/ d and the target dose of fluvoxamine was 200-300mg/d within 2 weeks, and the specific dose adjustment process was determined by the doctors on the basis of patients' conditions
Other Names:
  • fluvoxamine
Active Comparator: sertraline combined with aripiprazole
sertraline combined with aripiprazole treatment group:Gradually add the drug to the treatment dose, and monitor the symptom change, scale score, blood drug concentration and other indicators
Drug: sertraline
The initial dose of sertraline was 50mg/d and the initial dose of aripiprazole was 5mg/d. The target dose of sertraline was 200mg/ d and the target dose of aripiprazole was 5-20mg/d within 2 weeks, and the specific dose adjustment process was determined by the doctors on the basis of patients' conditions
Other Names:
  • aripiprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Y-BOCS score
Time Frame: 12 weeks
Treatment effectiveness was defined as a reduction of ≥35% in Y-BOCS score compared to baseline(12 weeks). Treatment recovery: Y-BOCS score below 8 (12 weeks)
12 weeks
Ratio of Y-BOCS score reduction from baseline
Time Frame: 12 weeks
Treatment effectiveness was defined as a reduction of ≥35% in Y-BOCS score compared to baseline(12 weeks).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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