Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT00174603
Status:
TERMINATED
Last Update Posted:
2008-01-10
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Depression With Quetiapine
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit subjects
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 examine the mood stabilizing and antipsychotic properties of quetiapine in the treatment of depression by comparing subjects who were randomly assigned to either quetiapine monotherapy, quetiapine and citalopram; or haloperidol and citalopram. We hypothesize that quetiapine monotherapy would have similar effects to the combination of a first generation antipsychotic plus an antidepressant for the treatment of a major depressive episode with psychosis.
Detailed Description:
Thus, current practice for treating psychotic depression is to combine an antidepressant with an antipsychotic. However, there are limitations to this approach. The rate of response is still lower than in other forms of major depression (Janicak et al., 2001). The rate of noncompliance is higher in this group; and the incidence of adverse effects related to the antipsychotic is increased (Janicak et al., 2001). As a result, studies have examined alternative treatments. The present study proposes to examine quetiapine's antipsychotic and mood stabilizing properties for the treatment of a major depressive disorder with psychotic features Subjects will be randomized to either quetipine monotherapy, quetiapine and citalopram; or haloperidol and citalopram.
Study Oversight
Has Oversight DMC:
False
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?: