Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2003-08-31

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

Conditions

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Depression

Keywords

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Depression Unipolar Depression Elderly depression Late-Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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paroxetine

Intervention Type DRUG

One night of Total Sleep Deprivation

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Charles F Reynolds III, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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970356

Identifier Type: -

Identifier Source: secondary_id

DATR A4-GPS