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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

Must not have

Diagnosis of certain sleep disorders or obstructive sleep apnea

History of moderate or severe traumatic brain injury or other neurological illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks post-randomization

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a sleep disorder or obstructive sleep apnea.

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I have had a serious brain injury or neurological illness.

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I have a condition that increases my risk of sudden heart-related death.

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I use certain sleep or calming medications at night.

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I am not taking any medications that can prolong the QT interval.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks post-randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index (ISI)

Secondary study objectives

PTSD Checklist for DSM-5

Pittsburgh Sleep Quality Index (PSQI)

Awards & Highlights

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.

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

0 / 7Eligibility criteria met