Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174590
Status:
TERMINATED
Last Update Posted:
2008-01-10
First Post:
2005-09-09
Brief Title:
Treatment of Major Depressive Disorder With Psychotic Features
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Treatment of Major Depressive Disorder With Psychotic Features With Risperidone Monotherapy Risperidone and Sertraline or Haloperidol and Sertraline
Status:
TERMINATED
Status Verified Date:
2007-12
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 determine the safety and efficacy of risperidone monotherapy in the treatment of psychotic depression We hypothesize that risperidone is as equally as effective as haloperidol plus sertraline for depression with psychotic features
Detailed Description:
Risperidone is a novel antipsychotic that is usually not associated with the adverse effects of neuroleptics In addition preliminary evidence suggests that it has additional mood stabilizing properties as compared with neuroleptics We are examining the effect of risperidone alone for the treatment of psychotic depression After providing written informed consent subjects with major depression and psychosis will undergo a routine medical and neurological evaluation If subjects qualify they will undergo a 3 to 7 day washout Subjects will be randomly assigned under double-blind conditions to risperidone plus placebo risperidone plus sertraline or haloperidol HPDL plus sertraline in a prospective parallel design for a 6 week trial Outcome measures include the Hamilton Rating Depression Scale The Positive and Negative Symptom Scale and the Clinician Administered Ratings Scale for Mania and Simpson Angus Scale Rating will be conducted on a weekly basis throughout the 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 |
|---|---|---|---|
| RIS-USA-248 | None | None | None |