Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056472
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2003-03-14
Brief Title:
Study of Pharmacotherapy of Psychotic Depression
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression
Status:
COMPLETED
Status Verified Date:
2013-06
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:
STOP-PD
Brief Summary:
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors SSRIs with antipsychotic medications in the treatment of psychotic depression
Detailed Description:
Approximately 25 of people who are admitted to hospitals for depression suffer from psychotic depression People with psychotic depression experience hallucinationsand more commonly delusions in addition to major depression Psychotic experiences may be either congruent with the theme of depression or incongruent without an apparent relationship to feeling depressed This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor SSRI with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion The study will also evaluate the difference in treatment response of young adults versus geriatric patients
This double-blind study will last a total of 12 weeks Participants will be randomly assigned to receive either olanzapine an atypical antipsychotic drug combined with sertraline an SSRI or olanzapine alone Following baseline assessments study visits will occur weekly until Week 6 and then bi-weekly until Week 12 Participants who do not respond to either treatment may leave the study at any time Participants who achieve either partial or full response may participate in an additional 20-week study
This double-blind study will last a total of 12 weeks Participants will be randomly assigned to receive either olanzapine an atypical antipsychotic drug combined with sertraline an SSRI or olanzapine alone Following baseline assessments study visits will occur weekly until Week 6 and then bi-weekly until Week 12 Participants who do not respond to either treatment may leave the study at any time Participants who achieve either partial or full response may participate in an additional 20-week 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 |
|---|---|---|---|
| U01MH062446 | NIH | None | httpsreporternihgovquickSearchU01MH062446 |
| U01MH062624 | NIH | None | None |
| U01MH062565 | NIH | None | None |
| U01MH062518 | NIH | None | None |