ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00000377R01MH043832R01MH043832DSIR AT-CTNCT00000377Preventing the Return of Depression in Elderly PatientsMaintenance Therapies in Late-Life DepressionUniversity of PittsburghOtherNational Institute of Mental Health (NIMH)NIH
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.
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
CompletedMarch 1989April 2000April 2000N/AInterventionalNoRandomizedTreatmentDepressionDrugNortriptyline
Inclusion Criteria:
-
Patients must have:
Recurrence of major depression while in a maintenance placebo condition in the currently
funded maintenance therapy protocol (Study I).
All60 Years80 YearsCharles Reynolds, MDPrincipal InvestigatorReynolds 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.156.8.1177.10450257June 2013November 2, 1999November 2, 1999November 3, 1999June 20, 2013June 20, 2013June 21, 2013Principal InvestigatorUniversity of PittsburghCharles ReynoldsDirector of the Aging Institute and UPMC Endowed Professor in Geriatric Psychiatry, Neurology, and NeuroscienceAgedAntidepressive AgentsDepressionDose-Response Relationship, DrugFemaleHumanMaleMiddle AgeNortriptylinePlacebosRecurrenceAged, 80 and overAntidepressive Agents -- *therapeutic useAntidepressive Agents -- administration & dosageDepression -- *drug therapyNortriptyline -- *therapeutic useNortriptyline -- administration & dosageDepressionDepressive DisorderNortriptyline