Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
|ClinicalTrials.gov Identifier: NCT00004310|
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Active, not recruiting
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: Clomipramine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Study Start Date :||October 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004310
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45267-0562|
|Study Chair:||Lorrin Koran||Stanford University|