Status:
RECRUITING
Intranasal Insulin for Posttraumatic Stress Disorder
Lead Sponsor:
VA Connecticut Healthcare System
Conditions:
PTSD
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.
Detailed Description
The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.
Eligibility Criteria
Inclusion
- Male or female, 21-65 years old
- Current PTSD
- Able to provide written informed consent
Exclusion
- Unstable medical condition, clinically determined by a physician
- Diabetes requiring insulin or oral hypoglycemic agents
- Moderate-severe traumatic brain injury
- Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months
- Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months
- Changes in doses of psychotropic medications in the past 4 weeks
- Initiation of individual therapy or counseling in the past 4 weeks
- Imminent suicidal or homicidal risk
- Contraindication to Insulin
- History of claustrophobia
- Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04044534
Start Date
October 31 2024
End Date
May 31 2026
Last Update
September 16 2025
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516