Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427128
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2007-01-24
Brief Title:
Prozac Treatment of Major Depression Discontinuation Study
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Prozac Treatment of Major Depression Discontinuation Study
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:
This study randomized two stratifications of acute phase MDD SSRI responders categorized as having either true drug response or placebo response pattern to continuation with SSRI vs placebo in a double-blind trial to determine if stratification category predicted continuation outcome
Detailed Description:
This study enrolled 627 subjects with Major Depressive illness at New York State Psychiatric Institute and Massachusetts General Hospital Subjects were treated with fluoxetine 10-60mg over a 12 week period The responder group was defined by those no longer meeting criteria for Major Depression at week 12 along with CGI ratings of much improved or very much improved as determined by an independent evaluator At week 12 non-responders were withdrawn from the study and received open label treatment responders were randomized in double-blind fashion to either fluoxetine continuation 20-80mg daily at response dose or placebo switch for up to 24 weeks The responder group was stratified by specific or true drug response late onset and persistent once attained and nonspecific or placebo response early onset or nonpersistent patterns Subjects were evaluated at one week and two week intervals at different phases of continuation treatment and depression relapse was determined by agreement between study psychiatrist and independent evaluator CGI and Ham-D ratings as well as administration of the MDD section of the Mood Disorders Module of the Structured Clinical Interview for DSM-IV Disorders at those visits A subset of study participants also provided DNA samples to determine whether there are any DNA markers of response type Data were analyzed to test the following hypotheses that during continuation fluoxetine treatment improved patients with a true drug acute response pattern randomized to placebo had a poorer outcome than those maintained on active drug that during continuation fluoxetine treatment improved patients with a placebo acute response pattern randomized to placebo had no worse an outcome than those maintained on drug that during continuation fluoxetine treatment patients with a true drug acute response pattern randomized to continue on fluoxetine were more likely to maintain their benefit than those with a placebo pattern
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 |
|---|---|---|---|
| RO1 MH56058 | None | None | None |