Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 23, 2015
December 1, 2013
2 years
July 11, 2014
October 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
8 weeks
Study Arms (2)
Fluvoxamine+Methylphenidate Hydrochloride
ACTIVE COMPARATORFluvoxamine: 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+sugar pill
PLACEBO COMPARATORFluvoxamine: 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong General Hospital, Guangdong academy of medical science
Guangzhou, Guangdong, 510180, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PHD
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 18, 2014
Study Start
October 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 23, 2015
Record last verified: 2013-12