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

NCT ID: NCT04963257

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-12-31

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

Conditions

OCD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

sertraline fluvoxamine

Intervention Type: DRUG

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 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

Group Type: ACTIVE_COMPARATOR

sertraline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

fluvoxamine; aripiprazole

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Affiliated Hospital of Zhejiang University Medical College

Yiwu, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zheng Lin, Doctor

Role: CONTACT

linzzr@126.com

13757118261

Facility Contacts

yunrong lu, doctor

Role: primary

13757118257@163.com

13757118257

Other Identifiers

2019-234

Identifier Type: -

Identifier Source: org_study_id