Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000377
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-02
Brief Title:
Preventing the Return of Depression in Elderly Patients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Maintenance Therapies in Late-Life 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:
None
Brief Summary:
The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment Nortriptyline is an antidepressant
This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment Patients are treated for 4 months to bring the depression under control Patients are then assigned randomly like tossing a coin to receive either the full dose of nortriptyline or half the usual dose of nortriptyline Patients continue taking nortriptyline for 2 years or until a major depression returns Throughout the study patients are monitored for symptoms of depression and other side effects
This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment Patients are treated for 4 months to bring the depression under control Patients are then assigned randomly like tossing a coin to receive either the full dose of nortriptyline or half the usual dose of nortriptyline Patients continue taking nortriptyline for 2 years or until a major depression returns Throughout the study patients are monitored for symptoms of depression and other side effects
Detailed Description:
To determine whether elderly 60-80 years old depressed patients who cannot sustain a remission without medication must be maintained at full acute-treatment dose To compare the efficacy of full-dose vs half-dose nortriptyline NT in preventing recurrences of major depression in the elderly To determine whether those patients who experience a recurrence while in a maintenance placebo condition Study I require 100 percent of their acute-treatment dose of NT to prevent subsequent recurrences or can be successfully maintained on 50 percent of their acute-treatment dose Study II
Investigators expect a pool of 60 patients from Study I to become eligible for Study II the full-dosehalf-dose maintenance trial After treatment of the recurrence and following 16 weeks of stabilization therapy patients are randomized to 1 of 2 maintenance therapy cells full-dose NT or half-dose NT Maintenance lasts 2 years or until recurrence of major depression The following are assessed differences in recurrence rates and time to recurrence under full-dose vs half-dose conditions differences in symptomatic ratings of depression suicidal ideation social adjustment and side effects and differences in compliance rates as determined by variability in level-to-dose LD ratios Exploratory data analyses are used to generate a hypothetical profile of elderly patients who can remain well on half-dose maintenance nortriptyline
For information on related studies please follow these links
httpclinicaltrialsgovshowNCT00178100
httpclinicaltrialsgovshowNCT00177671
Investigators expect a pool of 60 patients from Study I to become eligible for Study II the full-dosehalf-dose maintenance trial After treatment of the recurrence and following 16 weeks of stabilization therapy patients are randomized to 1 of 2 maintenance therapy cells full-dose NT or half-dose NT Maintenance lasts 2 years or until recurrence of major depression The following are assessed differences in recurrence rates and time to recurrence under full-dose vs half-dose conditions differences in symptomatic ratings of depression suicidal ideation social adjustment and side effects and differences in compliance rates as determined by variability in level-to-dose LD ratios Exploratory data analyses are used to generate a hypothetical profile of elderly patients who can remain well on half-dose maintenance nortriptyline
For information on related studies please follow these links
httpclinicaltrialsgovshowNCT00178100
httpclinicaltrialsgovshowNCT00177671
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 |
|---|---|---|---|
| DSIR AT-CT | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH043832 |
| R01MH043832 | NIH | None | None |