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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

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

Hypertension

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Connecticut Healthcare SystemLead Sponsor

81 Previous Clinical Trials

6,645 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarian patients eligible for this clinical investigation?

"This particular clinical trial is limited to patients between 21 and 65 years of age; however, there are 54 separate studies available for those below the age of consent as well as 374 trials focusing on seniors."

Answered by AI

Are there available vacancies in this experiment for individuals?

"Affirmative, according to the clinicaltrials.gov database this trial is actively enrolling. This research project was first introduced on February 1st 2023 and has been amended as recently as October 11th 2022. In total, 20 participants are sought from a single site for this study's purposes."

Answered by AI

Has the administration granted clearance to intranasal insulin?

"As a Phase 2 trial, Intranasal insulin has been deemed safe and received an overall score of 2. There is currently no evidence to suggest its efficacy yet."

Answered by AI

Is this medical experiment open to all individuals, or are there specific criteria for participation?

"This clinical trial requires 20 volunteers aged 21 to 65 years-old with a current diagnosis of PTSD and symptoms related to moral injury."

Answered by AI

How many applicants can be admitted to this investigation?

"Affirmative. Data hosted on clinicaltrials.gov shows that this investigation, which was initially posted on February 1st 2023, is actively recruiting patients. The study needs to enlist around 20 individuals from a single medical centre."

Answered by AI

Are there other precedents of employing Intranasal insulin in clinical tests?

"Presently, there are 71 research efforts currently underway to better understand the efficacy of Intranasal insulin. 13 of these projects have reached Phase 3 trials and 247 locations across the globe are running clinical studies for this medication. Wilmington, Delaware is home to a majority of these active investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intranasal Insulin for Posttraumatic Stress Disorder

Gihyun Yoon, MD 2024. "Intranasal Insulin for Posttraumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04044534.

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