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Insulin

Intranasal Insulin for Post-Traumatic Stress Disorder

Phase 2
Recruiting
Led By Gihyun Yoon, MD
Research Sponsored by VA Connecticut Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Summary

This trial is testing whether intranasal insulin can help reduce symptoms of PTSD.

Who is the study for?
This trial is for men and women aged 21-65 with current PTSD who can consent to participate. It's not for those with severe brain injuries, metal in their body that affects MRI, claustrophobia, recent changes in mental health treatments, unstable medical conditions, diabetes treated with insulin or pills, high suicide/homicide risk, contraindication to insulin use or certain psychiatric disorders.Check my eligibility
What is being tested?
The study tests if intranasal insulin can help reduce symptoms of PTSD compared to a placebo (a substance with no active drug). Participants will receive either the nasal spray containing insulin or a placebo without knowing which one they are getting.See study design
What are the potential side effects?
Potential side effects may include local irritation inside the nose from the spray and low blood sugar levels due to insulin. Other risks might be related to typical reactions from nasal sprays such as sneezing or runny nose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Traumatic Stress Disorder

Side effects data

From 2013 Phase 2 trial • 30 Patients • NCT01206322
7%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diabetes Group: Placebo
Control Group: Insulin
Diabetes Group: Insulin
Control Group: Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Subjects in this arm will receive placebo.
Group II: Intranasal insulinExperimental Treatment1 Intervention
Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intranasal insulin
2006
Completed Phase 2
~190
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

VA Connecticut Healthcare SystemLead Sponsor
82 Previous Clinical Trials
6,670 Total Patients Enrolled
Gihyun Yoon, MDPrincipal Investigator - VA Connecticut Healthcare System
VA Connecticut Healthcare System-West Haven Campus
Yonsei University (Medical School)
Yale New Haven Hospital (Residency)
5 Previous Clinical Trials
387 Total Patients Enrolled

Media Library

Intranasal Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT04044534 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Placebo, Intranasal insulin
Post-Traumatic Stress Disorder Clinical Trial 2023: Intranasal Insulin Highlights & Side Effects. Trial Name: NCT04044534 — Phase 2
Intranasal Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04044534 — Phase 2
~13 spots leftby Jan 2025