Intranasal Insulin for Posttraumatic Stress Disorder
Purpose
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.
Condition
- PTSD
Eligibility
- Eligible Ages
- Between 21 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female, 21-65 years old - Current PTSD - Able to provide written informed consent
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intranasal insulin |
Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day). |
|
|
Experimental Placebo |
Subjects in this arm will receive placebo. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- VA Connecticut Healthcare System
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.
