Skip to main content
OpenTrials
Completed

NCT Number: NCT04044534

Intranasal Insulin for Posttraumatic Stress Disorder

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

About this study

The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal insulin

Drug

Subjects in this arm will receive intranasal insulin (80 IU per day).

Placebo

Drug

Subjects in this arm will receive placebo.

Primary outcomes

  1. Change in PTSD Symptoms on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) From Pre- to Post-Intervention

    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). Findings are reported as change scores. For the medication group: CAPS score changes = CAPS score after taking medication for 1 week - CAPS score just before taking medication. For the placebo group: CAPS score changes = CAPS score after taking placebo for 1 week - CAPS score just before taking placebo. A negative value indicates a reduction in symptom severity.

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Registry information

Official study title

Intranasal Insulin for Treating Posttraumatic Stress Disorder

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.