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

NCT04963257 | Unknown Phase 4

• 1 other identifier: 2019-234
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

OCD

Keywords

sertraline; OCD; fluvoxamine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

sertraline combined with fluvoxamine

EXPERIMENTAL

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

sertraline combined with aripiprazole

ACTIVE COMPARATOR

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

Interventions

sertraline fluvoxamine 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

Also known as: fluvoxamine

sertraline combined with fluvoxamine

sertraline 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

Also known as: aripiprazole

sertraline combined with aripiprazole

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University Medical College

Yiwu, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Fluvoxamine; Sertraline; Aripiprazole

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Zheng Lin, Doctor

CONTACT

13757118261; linzzr@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: July 15, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)