Preventing the Return of Depression in Elderly Patients
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Nortriptyline (Drug)
Sponsored by: National Institute of Mental Health (NIMH)
Official(s) and/or principal investigator(s):
Charles Reynolds, MD, Principal Investigator
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
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.
Official title: Maintenance Therapies in Late-Life Depression
Study design: Treatment, Randomized
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.
Minimum age: 60 Years.
Maximum age: 80 Years.
Patients must have:
Recurrence of major depression while in a maintenance placebo condition in the currently
funded maintenance therapy protocol (Study I).
Locations and Contacts
Starting date: March 1989
Ending date: April 2000
Last updated: February 12, 2008