NCT00004310

Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Evaluate the efficacy of intravenous versus oral pulse loading of clomipramine (CMI) followed by a 12-week course of maintenance therapy in patients with obsessive compulsive disorder.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by participating institution. Patients are randomized into one of two treatment arms. Arm I: Patients receive a pulse loading dose of clomipramine (CMI) IV and an oral placebo on days 1 and 2. Arm II: Patients receive an oral pulse loading dose of CMI and an IV placebo on days 1 and 2. Patients receive maintenance therapy with daily oral CMI for 12 weeks beginning 4 days after pulse loading.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DRUG	Clomipramine

Timeline

• Start date: 1999-10-01
• First posted: 1999-10-19
• Last updated: 2005-06-24

Locations

2 sites across 1 country: United States