Intranasal Insulin for Posttraumatic Stress Disorder

September 15, 2025 updated by: Gihyun Yoon, MD, VA Connecticut Healthcare System

Intranasal Insulin for Treating Posttraumatic Stress Disorder

To evaluate if intranasal insulin is effective in reducing PTSD symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Recruiting
        • VA Connecticut Healthcare System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: 1 week
The five-point CAPS-5 consists of 20 PTSD symptoms rated on a 0-4 scale (total range: 0-80) as follows: (1) 5 Intrusion symptoms (0-20), (2) 2 Avoidance symptoms (0-8), (3) 7 Cognitions and mood symptoms (0-28), and (4) 6 Arousal and reactivity symptoms (0-24). Higher scores represent a worse outcome (i.e., more PTSD symptoms).
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Investigators

  • Principal Investigator: Gihyun Yoon, MD, VA Connecticut Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GY0005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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