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

OCD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963257
• Other study ID #: 2019-234
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zheng Lin, Doctor
• Phone: 13757118261
• Email: linzzr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• OCD

Intervention

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
• 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

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital of Zhejiang University Medical College	Yiwu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Y-BOCS score	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
Primary	Ratio of Y-BOCS score reduction from baseline	Treatment effectiveness was defined as a reduction of =35% in Y-BOCS score compared to baseline(12 weeks).	12 weeks