Pimavanserin for Insomnia in Veterans With PTSD

Part of paid clinical trials in Houston, Texas.

Sponsor
VA Office of Research and Development
Study ID
NCT05441280
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • pimavanserin — DRUG
    pimavanserin 34mg PO at bedtime
  • Placebo — OTHER
    The placebo is a pill that looks like a study medication but has no medication in it

Study Details

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.

Key Dates

Start date
Dec 28, 2023
Status verified
Apr 2026
Primary completion
Jul 12, 2027
Completion
Jul 12, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pimavanserin 34mg PO at bedtime
    Pimavanserin 34mg is taken by mouth at bedtime for 8 weeks .
  • Placebo Comparator: Placebo PO at bedtime
    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

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: 8 weeks post-randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Melissa B Jones, MD
[email protected]
713-794-1414
Ricardo E Jorge, MD
[email protected]
(713) 791-1414
Melissa B Jones, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
InsomniaPTSD (post-traumatic stress disorder)
By specialty
Mental healthSleep medicinePsychiatryBehavioral health
By research site
Michael E. DeBakey VA Medical Center, Houston, TX· Houston, TX

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