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

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: OCD

Treatments: Drug: sertraline; Drug: sertraline fluvoxamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04963257

2019-234

Details and patient eligibility

About

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

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

sertraline combined with fluvoxamine

Experimental group

Description:

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

Treatment:

Drug: sertraline fluvoxamine

sertraline combined with aripiprazole

Active Comparator group

Description:

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

Treatment:

Drug: sertraline