Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals
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|ClinicalTrials.gov Identifier: NCT00178035|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: paroxetine Behavioral: One night of Total Sleep Deprivation||Phase 4|
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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|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||158 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Geriatric Depression: Neurobiology of Treatment|
|Study Start Date :||December 1999|
|Study Completion Date :||August 2003|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178035
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Charles F Reynolds III, MD||University of Pittsburgh|