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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 belowSelect...
I agree not to begin any new treatments for insomnia, PTSD, or other mental health issues during the study.
Select...
I am a Veteran aged between 18 and 64.
PIP-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks post-randomization
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
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Who is running the clinical trial?
ACADIA Pharmaceuticals Inc.Industry Sponsor
47 Previous Clinical Trials
11,536 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,622 Previous Clinical Trials
3,323,661 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a sleep disorder or obstructive sleep apnea.I have a condition that increases my risk of sudden heart-related death.I agree not to begin any new treatments for insomnia, PTSD, or other mental health issues during the study.I have stopped taking certain mental health meds and strong CYP3A4 drugs.I have been on stable doses of my psychiatric medications for at least 1 month.I have had a serious brain injury or neurological illness.I do not have serious heart, lung, stomach, kidney, liver, brain, or other major health issues.I am a Veteran aged between 18 and 64.I use certain sleep or calming medications at night.I am not taking any medications that can prolong the QT interval.
Research Study Groups:
This trial has the following groups:- Group 1: Pimavanserin 34mg PO at bedtime
- Group 2: Placebo PO at bedtime
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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