Back to resultsSertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder
Primary Purpose
OCD
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sertraline fluvoxamine
sertraline
Sponsored by
About this trial
This is an interventional treatment trial for OCD focused on measuring sertraline, OCD, fluvoxamine
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.
Sites / Locations
- The Fourth Affiliated Hospital of Zhejiang University Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sertraline combined with fluvoxamine
sertraline combined with aripiprazole
Arm 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
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
Outcomes
Primary Outcome Measures
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)
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04963257
First Posted
November 17, 2019
Last Updated
July 6, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04963257
Brief Title
Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder
Official Title
A Randomized Controlled Trial of Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OCD
Keywords
sertraline, OCD, fluvoxamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sertraline combined with fluvoxamine
Arm Type
Experimental
Arm 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
Arm Title
sertraline combined with aripiprazole
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
sertraline fluvoxamine
Other Intervention Name(s)
fluvoxamine
Intervention Description
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
Intervention Name(s)
sertraline
Other Intervention Name(s)
aripiprazole
Intervention Description
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
Primary Outcome Measure Information:
Title
Y-BOCS score
Description
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)
Time Frame
12 weeks
Title
Ratio of Y-BOCS score reduction from baseline
Description
Treatment effectiveness was defined as a reduction of ≥35% in Y-BOCS score compared to baseline(12 weeks).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Lin, Doctor
Phone
13757118261
Email
linzzr@126.com
Facility Information:
Facility Name
The Fourth Affiliated Hospital of Zhejiang University Medical College
City
Yiwu
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yunrong lu, doctor
Phone
13757118257
Email
13757118257@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder
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