Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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 summary:

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


Criteria:

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 is Available At:


Original ID:

R01 MH037869-02


NCT ID:

NCT00178035


Secondary ID:

970356


Study Acronym:


Brief Title:

Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals


Official Title:

Geriatric Depression: Neurobiology of Treatment


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

158


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:December 1999
Completion Date:August 2003
Verification Date:July 2013
Last Changed Date:July 31, 2013
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary 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.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:EEG Sleep measures
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Cognitive status: Folstein Mini-Mental Status Exam, and CDR
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of Life measures: Quality of Wellbeing Scale, CIDI Health Services Utilization, OARS, GAF, PSQI, SF-36, UKU, and CIRS-G
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:MRI
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:paroxetine
Intervention Type:Behavioral
Name:One night of Total Sleep Deprivation

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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