Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 1:51 PM
Study NCT ID:
NCT04188392
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2019-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Pilot Feasibility Study of Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2022-08
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:
PIP
Brief Summary:
This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.
Detailed Description:
More treatments are needed to target insomnia in Veterans with Posttraumatic Stress Disorder. There is evidence to suggest that pimavanserin, a medication approved by the Food and Drug Administration for the treatment of psychosis in Parkinson's disease, may improve deep sleep and insomnia. This study preliminary assesses the feasibility of pimavanserin 34mg at bedtime for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress Disorder.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: