Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178048
Status:
COMPLETED
Last Update Posted:
2005-09-15
First Post:
2005-09-13
Brief Title:
Paroxetine in the Treatment of Chronic Primary Insomnia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Paroxetine in the Treatment of Chronic Primary Insomnia A Double-Blind Randomized Placebo-Controlled Study of Efficacy Over Six Weeks
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The goal of the study is to examine the role of paroxetine an antidepressant medication in the acute and continuation treatment of insomnia Primary insomnia is a type of insomnia not directly resulting from general medical chemical or psychiatric conditions
Detailed Description:
The primary aim of this study is to demonstrate the role of paroxetine in the acute treatment of chronic primary insomnia Paroxetine taken on a nightly basis in combination with sleep hygiene therapy will produce a greater number of diagnostic responders in acute treatment compared to a placebo and sleep hygiene control condition in a randomized double-blinded six-week acute treatment trial EEG sleep sleep quality and daytime well-being and daytime functioning will also show superior treatment effects during acute treatment with paroxetine plus sleep hygiene as compared with the placebo control condition
A total of 66 patients with primary insomnia as defined by DSM-IV criteria will be randomized 11 to receive paroxetine plus sleep hygiene therapy PSH-a or placebo plus sleep hygiene therapy PLSH-a in weekly acute treatment sessions evolving over a six-week interval in a double-blinded parallel group design
A total of 66 patients with primary insomnia as defined by DSM-IV criteria will be randomized 11 to receive paroxetine plus sleep hygiene therapy PSH-a or placebo plus sleep hygiene therapy PLSH-a in weekly acute treatment sessions evolving over a six-week interval in a double-blinded parallel group design
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