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Intranasal Insulin for Treating Posttraumatic Stress Disorder
NCT04044534Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2024
- Primary completion
- May 2026
- Countries
- 1
- Sponsor
- United States Department of Veterans Affairs
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Generex Oral-lyn
- Conditions
- post-traumatic stress disorder (PTSD)
01
Overview
Phase 2, randomised trial of Generex Oral-lyn in post-traumatic stress disorder (PTSD) (2 arms), sponsored by United States Department of Veterans Affairs. Primary endpoint: Clinician-Administered PTSD Scale for DSM-5 at 1 week. Started Oct 2024; status: completed.
02
Design
2 arms- Study design
- Randomized
Intranasal insulin
Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
Placebo
Subjects in this arm will receive placebo.
03
Who it enrols
Adults aged 21-65 with current PTSD, excluding those with unstable medical conditions, diabetes requiring medication, moderate-severe TBI, recent psychotic/bipolar/cognitive disorders, recent substance use disorders (except alcohol/tobacco/cannabis), recent changes in psychotropic meds or therapy, imminent suicidal risk, claustrophobia, or MRI contraindications.
04
Endpoints
Primary
Clinician-Administered PTSD Scale for DSM-5
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