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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00000377 |
Purpose
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.
| Condition | Intervention |
|
Depression |
Drug: Nortriptyline |
| MedlinePlus related topics: | Antidepressants Depression |
| Drug Information available for: | Nortriptyline Nortriptyline hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Maintenance Therapies in Late-Life Depression |
| Study Start Date: | March 1989 |
| Study Completion Date: | April 2000 |
| Primary Completion Date: | April 2000 (Final data collection date for primary outcome measure) |
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-dose/half-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 (L/D) ratios. Exploratory data analyses are used to generate a hypothetical profile of elderly patients who can remain well on half-dose maintenance nortriptyline.
Eligibility
| Ages Eligible for Study: | 60 Years to 80 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
-
Patients must have:
Recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (Study I).
Contacts and Locations More Information
| Study ID Numbers: | R01 MH43832, DSIR AT-CT |
| First Received: | November 2, 1999 |
| Last Updated: | February 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000377 |
| Health Authority: | United States: Federal Government |
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