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Completed

NCT Number: NCT00000378

Antidepressant Treatment of Melancholia in Late Life

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Melancholia Mental Disorders Mood Disorders

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1051 Riverside Drive

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline

Drug

12 week trial dose up to 200mgs

Nortriptyline

Drug

12 week trial dose adjusted to therapeutic level

Other names: nortiptyline

Primary outcomes

  1. HAMILTON Rating Scale for DEPRESSION Range

    Time frame: BASELINE COMPARED TO 12 WEEK MEASUREMENT

    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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Antidepressant Treatment of Melancholia in Late :Ife

Important dates

Study start
1997
Primary completion
2002
Study completion
2002
First posted
Nov 3, 1999
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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