Preventing the Return of Depression in Elderly Patients

NCT ID: NCT00000377

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 1989-03-31
• Study Completion Date: 2000-04-30

Brief 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.

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

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

Nortriptyline

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Charles Reynolds

Director of the Aging Institute and UPMC Endowed Professor in Geriatric Psychiatry, Neurology, and Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

References

Reynolds CF 3rd, Perel JM, Frank E, Cornes C, Miller MD, Houck PR, Mazumdar S, Stack JA, Pollock BG, Dew MA, Kupfer DJ. Three-year outcomes of maintenance nortriptyline treatment in late-life depression: a study of two fixed plasma levels. Am J Psychiatry. 1999 Aug;156(8):1177-81. doi: 10.1176/ajp.156.8.1177.

Reference Type: RESULT

PMID: 10450257 (View on PubMed)

Other Identifiers

R01MH043832

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR AT-CT

Identifier Type: -

Identifier Source: secondary_id

R01MH043832

Identifier Type: NIH

Identifier Source: org_study_id

View Link