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Trial NCT00000377

Resource URI: http://static.linkedct.org/resource/trials/NCT00000377
linkedct:brief_title Preventing the Return of Depression in Elderly Patients
linkedct:condition <http://static.linkedct.org/resource/condition/3728>
linkedct:criteria Inclusion Criteria: - Patients must have: Recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (Study I).
linkedct: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-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. For information on related studies, please follow these links: http://clinicaltrials.gov/show/NCT00178100 http://clinicaltrials.gov/show/NCT00177671
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_maximum_age 80 Years
linkedct:eligibility_minimum_age 60 Years
linkedct:end_date April 2000
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000377
rdfs:label Trial NCT00000377
linkedct:lastchanged_date February 19, 2009
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:nct_id NCT00000377
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Maintenance Therapies in Late-Life Depression
linkedct:org_study_id R01 MH043832-01
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/8665>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000377>
linkedct:phase N/A
linkedct:primary_completion_date April 2000
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2092>
linkedct:secondary_id DSIR AT-CT
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date March 1989
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2009