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

Phase 4

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Drug: Fluvoxamine+sugar pill; Drug: Fluvoxamine+Methylphenidate hydrochloride

• Registration Number: NCT02194075
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Status Verified: 2013-12
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-18
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluvoxamine+sugar pill	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.
Fluvoxamine+Methylphenidate Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	8 weeks

Trial Locations

Locations (1)

Guangdong General Hospital, Guangdong academy of medical science; 🇨🇳 Guangzhou, Guangdong, China