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Pimavanserin for Insomnia in Veterans with PTSD
NCT04809116Phase 4
Key facts
- Status
- Withdrawn
- Start
- Dec 2022
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Baylor College of Medicine
- Modality
- Small Molecules
- Drugs
- pimavanserin
- Conditions
- Insomnia
01
Overview
Phase 4, open-label, single-arm trial of pimavanserin in Insomnia, sponsored by Baylor College of Medicine. Primary endpoints: Recruitment rates at 7 months and Retention rates at 12 months. Planned start Dec 2022; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Open-label Pimavanserin
Pimavanserin 34mg at bedtime for 6 weeks
03
Who it enrols
Veterans aged 18-64 with PTSD and chronic insomnia, excluding those with primary psychotic disorders, moderate/severe substance use, high risk of sleep apnea, or prolonged QTc.
04
Endpoints
Primary
Recruitment rates
Retention rates
Secondary
Mean change in duration of stage N3 sleep pre- and post-treatment
Discontinuation rates due to adverse effects
Completion rates of key outcome measures
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