Pimavanserin 34mg PO at bedtime for Stress Disorders, Traumatic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Michael E. DeBakey VA Medical Center, Houston, TX, Houston, TX
Stress Disorders, Traumatic+4 More
pimavanserin - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a preliminary randomized, double-blind, placebo-controlled trial comparing pimavanserin 34mg at bedtime vs. placebo for the treatment of insomnia associated with post-traumatic stress disorder.

Eligible Conditions

  • Stress Disorders, Traumatic
  • Insomnia
  • Post-traumatic Stress Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stress Disorders, Traumatic

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 8 weeks post-randomization

8 weeks post-randomization
Insomnia Severity Index (ISI)
PTSD Checklist for DSM-5
Pittsburgh Sleep Quality Index (PS

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Stress Disorders, Traumatic

Trial Design

2 Treatment Groups

Pimavanserin 34mg PO at bedtime
1 of 2
Placebo PO at bedtime
1 of 2
Active Control
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Pimavanserin 34mg PO at bedtime · Has Placebo Group · Phase 2

Pimavanserin 34mg PO at bedtime
Drug
ActiveComparator Group · 1 Intervention: pimavanserin · Intervention Types: Drug
Placebo PO at bedtime
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks post-randomization
Closest Location: Michael E. DeBakey VA Medical Center, Houston, TX · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2002First Recorded Clinical Trial
11 TrialsResearching Stress Disorders, Traumatic
65 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,748,853 Total Patients Enrolled
106 Trials studying Stress Disorders, Traumatic
19,081 Patients Enrolled for Stress Disorders, Traumatic
Melissa B Jones, MDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX
2 Previous Clinical Trials
26 Total Patients Enrolled
2 Trials studying Stress Disorders, Traumatic
26 Patients Enrolled for Stress Disorders, Traumatic

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have insomnia and your insomnia is moderate.
You have a clinically significant PTSD symptom burden.
You are willing and able to comply with all aspects of the protocol.
Women of child-bearing potential who are sexually active must agree to use a method of contraception for the duration of the study

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.