Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212797
Status:
COMPLETED
Last Update Posted:
2015-11-26
First Post:
2005-09-15
Brief Title:
A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression 28130P05845
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Prospective Double-Blind Randomized Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunctive Therapy in Subjects With Psychotic Major Depression Major Depressive Episode Severe With Psychotic Features
Status:
COMPLETED
Status Verified Date:
2015-11
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:
Hermes
Brief Summary:
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517 Two doses of Org 34517 will be compared to placebo in this international multicenter study The duration of this trial is 6 weeks
Detailed Description:
Major depression with psychotic features psychotic depression is the most debilitating disorder in the depressive disorders spectrum It is associated with severe symptoms prolonged course poorer response rates more residual symptoms more frequent relapses and higher mortality as compared to major depressive disorder
The markedly abnormal HPA axis functioning in psychotic depression has encouraged research to investigate whether the HPA axis would be a target for pharmacotherapy in depression
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with GR antagonist Org 34517 Two doses of Org 34517 will be compared to placebo in this international multicenter study The duration of this trial is 6 weeks
The markedly abnormal HPA axis functioning in psychotic depression has encouraged research to investigate whether the HPA axis would be a target for pharmacotherapy in depression
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with GR antagonist Org 34517 Two doses of Org 34517 will be compared to placebo in this international multicenter study The duration of this trial is 6 weeks
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 |
|---|---|---|---|
| Protocol 28130 | None | None | None |