Phase 4 N=110 Randomized Triple-blind Treatment

Antidepressant Treatment of Melancholia in Late Life

Depression · Melancholia

Bottom Line

View on ClinicalTrials.gov: NCT00000378 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: HAMILTON Rating Scale for DEPRESSION Range — 27.3; 27.1; 10.7; 8.4 units on a scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sertraline (Drug); Nortriptyline (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Jun 2002

Outcome Measures

Outcome	Result	p-value
PRIMARY HAMILTON Rating Scale for DEPRESSION Range	27.3; 27.1; 10.7; 8.4	<0.05 sig

Summary

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00000378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.