Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals

University of Pittsburgh

Status and phase

Completed

Phase 4

Conditions

Depression

Treatments

Behavioral: One night of Total Sleep Deprivation

Drug: paroxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT00178035

970356

R01MH037869-02

DATR A4-GPS

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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