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Preventing the Return of Depression in Elderly Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000377
First Posted: November 3, 1999
Last Update Posted: June 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Charles Reynolds, University of Pittsburgh
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Maintenance Therapies in Late-Life Depression

Resource links provided by NLM:


Further study details as provided by Charles Reynolds, University of Pittsburgh:

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.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00178100

http://clinicaltrials.gov/show/NCT00177671

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000377


Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Charles Reynolds, MD
  More Information

Publications:
Responsible Party: Charles Reynolds, Director of the Aging Institute and UPMC Endowed Professor in Geriatric Psychiatry, Neurology, and Neuroscience, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00000377     History of Changes
Other Study ID Numbers: R01MH043832 ( U.S. NIH Grant/Contract )
DSIR AT-CT
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Charles Reynolds, University of Pittsburgh:
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nortriptyline
Antidepressive Agents
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs