drugset / Trial / NCT00000378

Antidepressant Treatment of Melancholia in Late Life

NCT00000378

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
1997-07
Primary completion
2002-06
Completion
2002-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nortriptyline Small molecule
Comparator Sertraline Small molecule 200 mg