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

October 22, 2015 updated by: sunnyrong, Guangdong Provincial People's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangdong General Hospital, Guangdong Academy of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluvoxamine+Methylphenidate Hydrochloride

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.
Drug: Fluvoxamine+Methylphenidate hydrochloride
Placebo Comparator: Fluvoxamine+sugar pill

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.
Drug: Fluvoxamine+sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

October 22, 2015

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2013006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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