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

ArmDescriptionAssigned Intervention
Experimental
Intranasal insulin
Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
  • Drug: Intranasal insulin
    Subjects in this arm will receive intranasal insulin (80 IU per day).
Experimental
Placebo
Subjects in this arm will receive placebo.
  • Drug: Placebo
    Subjects in this arm will receive placebo.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
VA Connecticut Healthcare System

Study Contact

Gihyun Yoon, MD
(203) 932-5711
gihyun.yoon@yale.edu

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.