Antidepressant Treatment of Melancholia in Late Life

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00000378
First received: November 2, 1999
Last updated: September 23, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression.

SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients.

Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication.

An individual may be eligible for this study if he/she:

Has unipolar major depression (with some exceptions) and is over 60 years old.


Condition Intervention
Depression
Melancholia
Drug: Sertraline
Drug: Nortriptyline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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

Study Start Date: July 1997
Estimated Study Completion Date: June 2002
Detailed Description:

To compare the efficacy and safety of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who meet DSM-IV criteria for unipolar major depression, excluding patients who meet criteria for psychotic or atypical subtype. To test the hypothesis that medication condition interacts with diagnostic subtype (melancholic vs non-melancholic) in determining antidepressant response. To examine the roles of symptom severity and alternative diagnostic subtyping in contributing to this pattern.

SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for depressed patients with melancholia. This issue is of particular concern in late-life major depression. SSRIs have important safety advantages with respect to overdose and a benign cardiovascular profile. Furthermore, the SSRIs do not have significant anticholinergic effects, and appear to be better tolerated than the TCAs. Perhaps most important, the SSRIs currently are prescribed widely as the medication treatment of first choice for major depression in late life. Therefore, if it were determined that SSRIs are considerably less effective than TCAs in the treatment of melancholia in the elderly, there would be significant ramifications for clinical practice.

Randomization to sertraline (a SSRI) or nortriptyline (a TCA) is stratified by the presence or absence of melancholia. Outcome measures for the 12-week acute phase include clinician and patient ratings of symptoms, side effects, and an evaluation of the health-related quality of life (HRQOL). At the end of the acute treatment phase, patients who meet criteria for clinical response participate in a 6-month continuation phase.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Patients must have:

Unipolar major depression (per DSM-IV criteria) with or without melancholia.

Exclusion Criteria:

-

Patients with the following symptoms or conditions are excluded:

Psychotic or atypical subtype of unipolar major depression.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000378

Locations
United States, New York
1051 Riverside Drive
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Steven P. Roose, MD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000378     History of Changes
Other Study ID Numbers: R01 MH55716, DSIR AT-GP
Study First Received: November 2, 1999
Last Updated: September 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Aged
Antidepressive Agents, Tricyclic
Depression
Female
Human
Male
Middle Age
Nortriptyline
Sertraline
Serotonin Uptake Inhibitors
Antidepressive Agents, Tricyclic -- *therapeutic use
Antidepressive Agents, Tricyclic -- adverse effects
Depression -- *drug therapy
Nortriptyline -- *therapeutic use
Nortriptyline -- adverse effects
Sertraline -- *therapeutic use
Sertraline -- adverse effects
Serotonin Uptake Inhibitors -- *therapeutic use
Serotonin Uptake Inhibitors -- adverse effects

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Nortriptyline
Sertraline
Antidepressive Agents, Tricyclic
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on July 24, 2014