Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

July 31, 2013 updated by: University of Pittsburgh

Geriatric Depression: Neurobiology of Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
MRI
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Charles F Reynolds III, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH037869-02 (U.S. NIH Grant/Contract)
  • DATR A4-GPS
  • 970356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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