Back to resultsMethylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fluvoxamine+Methylphenidate hydrochloride
Fluvoxamine+sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Informed consent
- Met DSM-V criteria
- Y-BOCS ≥ 16
- Course of illness ≥ 1year
- Age range between 18~40 years old
- Junior high school education level above
Exclusion Criteria:
- Any other psychiatric axis-I or axis-II disorders
- History of epileptic seizures or any other neurological disorder
- Any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser
Sites / Locations
- Guangdong General Hospital, Guangdong academy of medical science
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fluvoxamine+Methylphenidate Hydrochloride
Fluvoxamine+sugar pill
Arm Description
Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks. Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks.
Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks. sugar pill: tablet, 1-2 tablets/d, were treated with a course of 8 weeks.
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02194075
First Posted
July 11, 2014
Last Updated
October 22, 2015
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02194075
Brief Title
Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in OCD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluvoxamine+Methylphenidate Hydrochloride
Arm Type
Active Comparator
Arm Description
Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.
Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks.
Arm Title
Fluvoxamine+sugar pill
Arm Type
Placebo Comparator
Arm Description
Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.
sugar pill: tablet, 1-2 tablets/d, were treated with a course of 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine+Methylphenidate hydrochloride
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine+sugar pill
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent
Met DSM-V criteria
Y-BOCS ≥ 16
Course of illness ≥ 1year
Age range between 18~40 years old
Junior high school education level above
Exclusion Criteria:
Any other psychiatric axis-I or axis-II disorders
History of epileptic seizures or any other neurological disorder
Any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser
Facility Information:
Facility Name
Guangdong General Hospital, Guangdong academy of medical science
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
12. IPD Sharing Statement
Learn more about this trial
Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
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