Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

Depression Clinical Trial

Official title:

Geriatric Depression: Neurobiology of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178035
• Other study ID #: R01 MH037869-02
• Secondary ID: 970356DATR A4-GP
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 31, 2013
• Start date: December 1999
• Est. completion date: August 2003

Study information

• Verified date: July 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• paroxetine

Behavioral:
• One night of Total Sleep Deprivation

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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