Status and phase
Conditions
Treatments
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
Ages
Volunteers
Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal