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Pimavanserin for Insomnia in Veterans With PTSD

NCT05441280 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-04

No results posted yet for this 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.

Conditions

  • Post-traumatic Stress Disorder
  • Insomnia

Interventions

DRUG

pimavanserin

pimavanserin 34mg PO at bedtime

OTHER

Placebo

The placebo is a pill that looks like a study medication but has no medication in it

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Melissa B Jones, MD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2027-07-12
Completion
2027-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441280 on ClinicalTrials.gov