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

NCT ID: NCT02194075

Last Updated: 2015-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fluvoxamine+Methylphenidate hydrochloride

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Fluvoxamine+sugar pill

Intervention Type DRUG

Interventions

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Fluvoxamine+Methylphenidate hydrochloride

Intervention Type DRUG

Fluvoxamine+sugar pill

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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sunnyrong

MD,PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangdong General Hospital, Guangdong academy of medical science

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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B2013006

Identifier Type: -

Identifier Source: org_study_id

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