Using intranasal insulin to treat PTSD symptoms
Intranasal Insulin for Treating Posttraumatic Stress Disorder
This study is testing if a nasal spray of insulin can help adults with PTSD feel better by reducing their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | VA Connecticut Healthcare System Federal |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT04044534 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intranasal insulin in reducing symptoms of posttraumatic stress disorder (PTSD) and aims to inhibit hyperactivation of the amygdala in affected individuals. Participants will receive either intranasal insulin or a placebo to assess the pharmacotherapeutic effects on their PTSD symptoms. The study focuses on adults aged 21-65 who currently experience PTSD and can provide informed consent. The research is conducted at the VA Connecticut Healthcare System.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 who have a current diagnosis of PTSD.
Not a fit: Patients with unstable medical conditions, diabetes requiring insulin, or certain psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for individuals suffering from PTSD.
How similar studies have performed: While the use of intranasal insulin for PTSD is a novel approach, similar studies exploring insulin's effects on brain function have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
West Haven, Connecticut
- VA Connecticut Healthcare System — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Gihyun Yoon, MD — VA Connecticut Healthcare System
- Study coordinator: Gihyun Yoon, MD
- Email: gihyun.yoon@yale.edu
- Phone: (203) 932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.