Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals
Behavioral: One night of Total Sleep Deprivation
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Geriatric Depression: Neurobiology of Treatment|
- Combined treatment of total sleep deprivation(TSD)for one night + paroxetine will be superior to the combination of placebo + TSD and to paroxetine alone (without TSD)in bringing about rapid resolution of depressive symptoms.
- EEG Sleep measures
- Cognitive status: Folstein Mini-Mental Status Exam, and CDR
- Quality of Life measures: Quality of Wellbeing Scale, CIDI Health Services Utilization, OARS, GAF, PSQI, SF-36, UKU, and CIRS-G
- Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale
- Psychiatric status: SCID, Hamilton Depression Rating Scale, Suicidal History Questionnaire, Antidepressant Treatment History Form, Brief Psychiatric Rating Scale, and anxiety subscale of Brief Symptom Inventory
|Study Start Date:||December 1999|
|Estimated Study Completion Date:||August 2003|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00178035
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Charles F Reynolds III, MD||University of Pittsburgh|