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Last Update Posted: 2013-06-21
Recruiting has ended
All Genders accepted | 60 Years-80 Years |
Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Preventing the Return of Depression in Elderly Patients
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.
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.
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Eligibility
Relevant conditions:
Depression
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
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Data sourced from ClinicalTrials.gov