Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178035
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 2, 2013
Information provided by:
University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Drug: paroxetine Behavioral: One night of Total Sleep Deprivation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Geriatric Depression: Neurobiology of Treatment
Study Start Date : December 1999
Study Completion Date : August 2003

Primary Outcome Measures :
  1. 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 :
  1. EEG Sleep measures
  2. Cognitive status: Folstein Mini-Mental Status Exam, and CDR
  3. Quality of Life measures: Quality of Wellbeing Scale, CIDI Health Services Utilization, OARS, GAF, PSQI, SF-36, UKU, and CIRS-G
  4. Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale
  5. 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
  6. MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00178035

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Charles F Reynolds III, MD University of Pittsburgh

Additional Information: Identifier: NCT00178035     History of Changes
Other Study ID Numbers: R01MH037869-02 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2013

Keywords provided by University of Pittsburgh:
Unipolar Depression
Elderly depression

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors