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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04963257
Enrollment
400
Registered
2021-07-15
Start date
2020-01-01
Completion date
2024-12-31
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OCD

Keywords

sertraline, OCD, fluvoxamine

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

Interventions

DRUGsertraline 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

DRUGsertraline

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Y-BOCS score12 weeksTreatment 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 baseline12 weeksTreatment effectiveness was defined as a reduction of ≥35% in Y-BOCS score compared to baseline(12 weeks).

Countries

China

Contacts

Primary ContactZheng Lin, Doctor
linzzr@126.com13757118261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026