Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Geriatric Depression: Neurobiology of Treatment

Conditions
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Depression

Intervention / Treatment
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* Drug: paroxetine
* Behavioral: One night of Total Sleep Deprivation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 and older Current episode of unipolar, major depression HRSD (17 item)score of 15 or higher Folstein Mini-Mental Status exam score of 17 or higher Exclusion Criteria: Lifetime diagnosis of any psychotic disorder Lifetime diagnosis of bipolar disorder _Alcohol or drug abuse within the past 6 months Contraindication to treatment with SSRI therapy History of seizure disorder Baseline apnea/hypopnea index of 20 or higher Hyponatremia

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paroxetine|nan|
|Behavioral: One night of Total Sleep Deprivation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| MRI |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Unipolar Depression, Elderly depression, Late-Life