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NCT02194075 Clinical Trial

Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02194075
Other study ID # B2013006
Secondary ID
Status Completed
Phase Phase 4
First received July 11, 2014
Last updated October 22, 2015
Start date October 2013
Est. completion date October 2015

Study information
Verified date December 2013
Source Guangdong General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Guangdong Province
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvoxamine+Methylphenidate hydrochloride

• Fluvoxamine+sugar pill

Locations
Country Name City State
China Guangdong General Hospital, Guangdong academy of medical science Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Yale-Brown Obsessive Compulsive Scale (Y-BOCS) 8 weeks Yes
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