Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178035
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2005-09-13
Brief Title:
Sleep Deprivation Plus Paroxetine for Treating Major Depression in Elderly Individuals
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Geriatric Depression Neurobiology of Treatment
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1TSD paroxetine 2TSD placebo and 3paroxetine 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
httpclinicaltrialsgovshowNCT00177294
httpclinicaltrialsgovshowNCT00178074
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 1TSD paroxetine 2TSD placebo and 3paroxetine 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
httpclinicaltrialsgovshowNCT00177294
httpclinicaltrialsgovshowNCT00178074
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A4-GPS | None | None | None |
| 970356 | None | None | None |