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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Completed; Phase 4

Conditions: Obsessive Compulsive Disorder

Treatments: Drug: Fluvoxamine+sugar pill; Drug: Fluvoxamine+Methylphenidate hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02194075

B2013006

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Fluvoxamine+Methylphenidate Hydrochloride

Active Comparator group

Description:

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.

Treatment:

Drug: Fluvoxamine+Methylphenidate hydrochloride

Fluvoxamine+sugar pill

Placebo Comparator group

Description:

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.

Treatment:

Drug: Fluvoxamine+sugar pill