RECRUITINGPhase 2INTERVENTIONAL
Intranasal Insulin for Posttraumatic Stress Disorder
Intranasal Insulin for Treating Posttraumatic Stress Disorder
About This Trial
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.
Who May Be Eligible (Plain English)
Who May Qualify:
- Male or female, 21-65 years old
- Current PTSD
- Able to provide written willing to sign a consent form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Intranasal insulin
Subjects in this arm will receive intranasal insulin (80 IU per day).
DRUG
Placebo
Subjects in this arm will receive placebo.
Locations (1)
VA Connecticut Healthcare System
West Haven, Connecticut, United States