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

Phase 2

• Conditions: Obsessive-Compulsive Disorder

• Registration Number: NCT00004310
• Lead Sponsor: National Center for Research Resources (NCRR)

Brief 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.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2003-12
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States