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Preventing the Return of Depression in Elderly Patients
This study has been completed.
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
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: Maintenance Therapies in Late-Life Depression

Further study details as provided by National Institute of Mental Health (NIMH):

Study Start Date: March 1989
Study Completion Date: April 2000
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
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-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
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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000377

Sponsors and Collaborators
Investigators
Principal Investigator: Charles Reynolds, MD
  More Information

Publications of Results:
Study ID Numbers: R01 MH43832, DSIR AT-CT
Study First Received: November 2, 1999
Last Updated: February 12, 2008
ClinicalTrials.gov Identifier: NCT00000377  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Aged
Antidepressive Agents
Depression
Dose-Response Relationship, Drug
Female
Human
Male
Middle Age
Nortriptyline
Placebos
Recurrence
Aged, 80 and over
Antidepressive Agents -- *therapeutic use
Antidepressive Agents -- administration & dosage
Depression -- *drug therapy
Nortriptyline -- *therapeutic use
Nortriptyline -- administration & dosage

Study placed in the following topic categories:
Depression
Mental Disorders
Nortriptyline
Mood Disorders
Depressive Disorder
Recurrence
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions
Antidepressive Agents, Tricyclic

ClinicalTrials.gov processed this record on January 15, 2009