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

Phase 4

Recruiting

• Conditions: OCD
• Interventions: Drug: sertraline fluvoxamine; Drug: sertraline

• Registration Number: NCT04963257
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-11-17
• Study Start: 2020-01-01
• Status Verified: 2021-06
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sertraline combined with fluvoxamine	sertraline 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
sertraline combined with aripiprazole	sertraline	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

Primary Outcome Measures

Name	Time	Method
Y-BOCS score	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)
Ratio of Y-BOCS score reduction from baseline	12 weeks	Treatment effectiveness was defined as a reduction of ≥35% in Y-BOCS score compared to baseline(12 weeks).

Trial Locations

Locations (1)

The Fourth Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Yiwu, Zhejiang, China