Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004310
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SUMC-36784 | None | None | None |