Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167154
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2005-09-10
Brief Title:
Risperidone and Suicidality in Major Depressive Disorder
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2021-06
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:
None
Brief Summary:
The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder
Detailed Description:
Using a double blind placebo-controlled design subjects diagnosed with a current episode of major depressive disorder defined by DSM-IV criteria and supported by the Mini International Neuropsychiatric Interview severe with suicidality despite currently taking an antidepressant will be enrolled in the eight-week study The treatment will be initiated by randomizing patients to receive risperidone or placebo in addition to the antidepressant that the patient is already taking The clinical efficacy will be evaluated after 4 days weekly for 4 weeks then every other week for 4 weeks with the efficacy measures During the eight-week study treatment with risperidone or placebo will continue at the highest effective dosage up to 2 mg per day The dose of the antidepressant will not be changed during 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-DED-402 | None | None | None |