Antidepressant Treatment of Melancholia in Late Life

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00000378
First received: November 2, 1999
Last updated: October 6, 2015
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 Phase
Depression
Melancholia
Drug: Sertraline
Drug: Nortriptyline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antidepressant Treatment of Melancholia in Late :Ife

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • HAMILTON Rating Scale for DEPRESSION Range [ Time Frame: BASELINE COMPARED TO 12 WEEK MEASUREMENT ] [ Designated as safety issue: No ]
    Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement


Enrollment: 110
Study Start Date: July 1997
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sertaline
patients randomized to sertraline 12 week trial does up to 200mgs
Drug: Sertraline
12 week trial dose up to 200mgs
Active Comparator: nortriptyline
patients randomized to nortriptyline dose adjusted to therapeutic level
Drug: Nortriptyline
12 week trial dose adjusted to therapeutic level
Other Name: nortiptyline

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 Diagnostic and Statistical Manuel-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 to 95 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have:

Unipolar major depression (per Diagnostic and Statistical Manuel-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
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Steven P. Roose, MD New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00000378     History of Changes
Other Study ID Numbers: #3105  R01MH055716 
Study First Received: November 2, 1999
Results First Received: April 2, 2015
Last Updated: October 6, 2015
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
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
Sertraline
Nortriptyline
Serotonin Uptake Inhibitors
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on August 22, 2016