Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518947
Status:
COMPLETED
Last Update Posted:
2011-02-25
First Post:
2007-08-08
Brief Title:
Pharmacotherapy of Treatment-Resistant Mania
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pharmacotherapy of Treatment-Resistant Mania
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
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:
TRM
Brief Summary:
Verapamil has been found in some but not all studies to have antimanic activity Therefore we investigated the use of verapamil alone or as an adjunctive treatment in manic patients who did not respond to an initial adequate trial of lithium Each study phase lasted three weeks Subjects were treated openly with lithium in Phase 1 n45 Those who failed to respond were randomly assigned to double-blind treatment in Phase 2 with either verapamil n10 or continued lithium n8 Phase 2 responders were continued on the same medication in Phase 3 Phase 2 nonresponders n10 were assigned to combined verapamillithium in Phase 3
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None