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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
Information provided by:
University of Pittsburgh

September 13, 2005
September 15, 2005
August 2, 2013
December 1999
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00178035 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals
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.

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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Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
  • Drug: paroxetine
  • Behavioral: One night of Total Sleep Deprivation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2003
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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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH037869-02( U.S. NIH Grant/Contract )
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University of Pittsburgh
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Principal Investigator: Charles F Reynolds III, MD University of Pittsburgh
University of Pittsburgh
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP