CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 110 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline up to 200 mg daily or nortriptyline adjusted to therapeutic level, each for 12 weeksAI-extracted
Key inclusion· 1
  • Unipolar major depression diagnosed per DSM-IV criteria, with or without melancholia
Key exclusion· 1
  • Psychotic or atypical subtype of unipolar major depression

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000378
NCT00000378Phase 4Completed

Antidepressant Treatment of Melancholia in Late :Ife

New York State Psychiatric Institute·interventional·Posted Nov 3, 1999·Updated Oct 7, 2015

In Brief

A Phase 4 clinical trial evaluating Sertraline and Nortriptyline for Depression and Melancholia. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 1999
Enrollment StartJul 1, 1997
Primary CompletionJun 1, 2002
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 26.7 years ago

Interventions

Sertralinedrug

12 week trial dose up to 200mgs

Nortriptylinedrug

12 week trial dose adjusted to therapeutic level