Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

Depression Clinical Trial

Official title: Geriatric Depression: Neurobiology of Treatment

Status Completed

Clinical Trial Summary

This study will determine the effectiveness of total sleep deprivation (TSD) for one night plus paroxetine versus either TSD plus placebo or paroxetine alone in inducing rapid symptom resolution of major depression in the elderly.

Clinical Trial Description

The clinical response to antidepressant treatment in the elderly is variable and often slow, and difficult to predict reliably before 4-5 weeks of treatment. The delayed onset of antidepressant activity is particularly problematic in the elderly, prolonging the duration of suffering and disability, reducing compliance, and increasing the risk for attempted and completed suicide.

This study seeks to develop a method for effective rapid treatment of major depressive episodes in the elderly and to improve early identification of treatment non-responders, by combining sleep deprivation (for one night) and paroxetine as probes of treatment response and treatment resistance.

This is an experimental study that is randomized, double-blind, and placebo-controlled. We will recruit 158 elderly depressed patients with current major depressive episodes and randomly assign 36 patients to each of three interventions: 1)TSD + paroxetine; 2)TSD + placebo; and 3)paroxetine alone without TSD). The duration of the experimental phase of the study is 17 days: 3 days for pre-treatment sleep studies and 14 days for initial paroxetine or placebo treatment under double-blind conditions.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00177294

http://clinicaltrials.gov/show/NCT00178074 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT00178035
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: Phase 4
• Start date: December 1999
• Completion date: August 2003