Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340379
Status:
COMPLETED
Last Update Posted:
2014-08-19
First Post:
2006-06-20
Brief Title:
Ziprasidone vs SertralineHaloperidol in Psychotic Depression
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Comparison of Two Different Treatments for Major Depression With Psychotic Features Ziprasidone vs Combined Sertraline and Haloperidol
Status:
COMPLETED
Status Verified Date:
2012-02
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:
None
Brief Summary:
The purpose of this study is to compare ziprasidone Geodon monotherapy for the treatment of psychotic major depression PMDwith an antidepressantantipsychotic combined therapy
Detailed Description:
Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations andor delusions as part of the clinical presentation Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant sertraline and an antipsychotic haloperidol over a 12-week period An additional 12-week extension phase is also included for responders to the initial study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3846-05-6R2 | OTHER | Duke legacy protocol number | None |