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Serotonin Receptor Antagonist

Pimavanserin for PTSD-Related Insomnia (PIP-II Trial)

Phase 2
Recruiting
Led By Melissa B Jones, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to not start concurrent behavioral or other treatment programs for insomnia, PTSD, or other psychiatric disorders during the study
Adult, male and female Veterans, aged 18-64
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks post-randomization
Awards & highlights

PIP-II Trial Summary

This trial is testing a new drug to see if it's effective in treating insomnia that's caused by PTSD.

Who is the study for?
This trial is for male and female Veterans aged 18-64 with chronic insomnia and PTSD. Participants must meet specific sleep dissatisfaction criteria, have stable PTSD symptoms, not start other treatments during the study, and agree to contraception if applicable. Exclusions include psychotic disorders, substance abuse, certain brain injuries or neurological illnesses, some cardiovascular conditions, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The trial tests pimavanserin (34mg at bedtime) against a placebo in treating insomnia linked to PTSD. It's randomized and double-blind; neither participants nor researchers know who gets the real drug versus the placebo until after results are collected.See study design
What are the potential side effects?
Pimavanserin may cause side effects like irregular heartbeats that could lead to severe conditions such as torsades de pointes or sudden death. Other potential side effects aren't specified but monitoring for common drug reactions would be expected.

PIP-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to begin any new treatments for insomnia, PTSD, or other mental health issues during the study.
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I am a Veteran aged between 18 and 64.

PIP-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index (ISI)
Secondary outcome measures
PTSD Checklist for DSM-5
Pittsburgh Sleep Quality Index (PS

PIP-II Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Pimavanserin 34mg PO at bedtimeActive Control1 Intervention
Pimavanserin 34mg is taken by mouth at bedtime for 8 weeks .
Group II: Placebo PO at bedtimePlacebo Group1 Intervention
The active study medication listed above will be compared with a placebo, which is a pill that looks like a study medication but has no medication in it

Find a Location

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Industry Sponsor
46 Previous Clinical Trials
10,880 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,124 Total Patients Enrolled
26 Trials studying Insomnia
4,137 Patients Enrolled for Insomnia
Melissa B Jones, MDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX
2 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Insomnia
6 Patients Enrolled for Insomnia

Media Library

Pimavanserin (Serotonin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05441280 — Phase 2
Insomnia Research Study Groups: Pimavanserin 34mg PO at bedtime, Placebo PO at bedtime
Insomnia Clinical Trial 2023: Pimavanserin Highlights & Side Effects. Trial Name: NCT05441280 — Phase 2
Pimavanserin (Serotonin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441280 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial open to participants aged 45 or above?

"This research is open to individuals aged 18 or above, and under the age of 64."

Answered by AI

What qualifications are necessary to take part in this clinical investigation?

"This clinical trial is seeking 60 adults between 18-64 years old who are Veterans dealing with stress disorders and have difficulty falling asleep, staying asleep, or waking up earlier than desired. The insomnia should be present at least 3 times a week for 3 months with associated daytime impairment confirmed by an Insomnia Severity Index (ISI) total score of 15. Additionally, the PTSD Checklist (PCL-5) must demonstrate clinically significant symptoms with a total score of 33 as the recommended cutoff. Finally, women of childbearing age who may engage in intercourse will need to agree to use contraception methods like hormonal contraceptives during their participation in this study"

Answered by AI

Is there still space available for individuals to participate in this experiment?

"This research initiative, which was first posted on September 1st 2023, is not presently recruiting participants. As per clinicaltrials.gov's records, the trial was last updated on October 19th 2022 and has since ceased participant recruitment efforts; however 564 other studies are currently searching for volunteers."

Answered by AI

What threats can Pimavanserin 34mg PO at bedtime pose to patients?

"Based on evaluations conducted by Power, the safety of Pimavanserin 34mg PO at bedtime was rated 2 due to its standing as a Phase 2 trial and the presence of safety data but no efficacy evidence."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Michael E. DeBakey VA Medical Center, Houston, TX
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried everything! I am really affected by my PTSD and insomnia. I hope that you will contact me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Pimavanserin for Insomnia in Veterans With PTSD
2023. "Pimavanserin for Insomnia in Veterans With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05441280.
All > Ptsd Houston > Nuplazid
~40 spots leftby Jul 2027
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