Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369746
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2006-08-24
Brief Title:
STARD Alcohol Treatment of Depression Concurrent With Alcohol Abuse
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Treatment of Depression Concurrent With Alcohol Abuse an Extension of Alcohol Use Disorder in Patients Treated for Depression
Status:
COMPLETED
Status Verified Date:
2011-12
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 if having an alcohol use disorder affects recovery from depression and also whether recovery from depression in patients who have alcohol use disorders is also accompanied by improvement in the alcohol use disorder
Detailed Description:
This is an extension of the multi-site sub-study of the National Institute of Mental Health NIMH protocol Sequenced Treatment Alternatives to Relieve Depression STARD which utilized the infrastructure of the Depression Trials Network to enroll 4000 subjects diagnosed with Major Depressive Disorder These subjects initially received 12 weeks of treatment with the anti-depressant citalopram The thrust of this study was to test treatment algorithms for those subjects who did not respond adequately to initial monotherapy treatment with citalopram or who were unable to tolerate it The parent protocol also contained several ancillary studies including a sub-study of subjects with co-morbid alcohol use disorders which enrolled 130 subjects Treatment response data was collected at multiple intervals during the 12 week treatment period on depressed subjects both with and without a co-morbid alcohol use disorder
Comparison Treatment outcome measures of subjects diagnosed with Major Depressive Disorder will be compared to treatment outcome measures of subjects diagnosed with Major Depressive Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment period This comparison will show whether having a co-morbid alcohol use disorder affects recovery from depression In addition alcohol use data of depressed subjects who demonstrated a positive response to anti-depressant treatment will be compared with alcohol use data of depressed subjects who did not have positive treatment outcomes This comparison will show whether recovery from depression is associated with improvement in the co-morbid alcohol use disorder
Comparison Treatment outcome measures of subjects diagnosed with Major Depressive Disorder will be compared to treatment outcome measures of subjects diagnosed with Major Depressive Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment period This comparison will show whether having a co-morbid alcohol use disorder affects recovery from depression In addition alcohol use data of depressed subjects who demonstrated a positive response to anti-depressant treatment will be compared with alcohol use data of depressed subjects who did not have positive treatment outcomes This comparison will show whether recovery from depression is associated with improvement in the co-morbid alcohol use disorder
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 |
|---|---|---|---|
| R01AA013303 | NIH | None | httpsreporternihgovquickSearchR01AA013303 |