NCT00000377

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1989

Longer than P75 for not_applicable depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1989

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

11.1 years

First QC Date

November 2, 1999

Last Update Submit

June 20, 2013

Conditions

Depression

Keywords

AgedAntidepressive AgentsDepressionDose-Response Relationship, DrugFemaleHumanMaleMiddle AgeNortriptylinePlacebosRecurrenceAged, 80 and overAntidepressive Agents -- *therapeutic useAntidepressive Agents -- administration & dosageDepression -- *drug therapyNortriptyline -- *therapeutic useNortriptyline -- administration & dosage

Interventions

NortriptylineDRUG

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (Study I).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 10450257RESULT

MeSH Terms

Conditions

DepressionRecurrence

Interventions

Nortriptyline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Charles Reynolds, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Aging Institute and UPMC Endowed Professor in Geriatric Psychiatry, Neurology, and Neuroscience

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

March 1, 1989

Primary Completion

April 1, 2000

Study Completion

April 1, 2000

Last Updated

June 21, 2013

Record last verified: 2013-06