Clinical trial NCT00178035: Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals
Official title: Geriatric Depression: Neurobiology of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Depression
Unipolar Depression
Elderly depression
Late-Life
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 158
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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

Primary outcomes:
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.
Secondary outcomes:
measure: EEG Sleep measures
measure: Cognitive status: Folstein Mini-Mental Status Exam, and CDR
measure: Quality of Life measures: Quality of Wellbeing Scale, CIDI Health Services Utilization, OARS, GAF, PSQI, SF-36, UKU, and CIRS-G
measure: Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale
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
measure: MRI
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Charles F Reynolds III, MD
role: PRINCIPAL_INVESTIGATOR
References: