Intranasal Insulin for Posttraumatic Stress Disorder

PTSD Clinical Trial

Official title:

Intranasal Insulin for Treating Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044534
• Other study ID #: GY0005
• Status: Recruiting
• Phase: Phase 2
• Start date: July 31, 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: VA Connecticut Healthcare System
• Contact: Gihyun Yoon, MD
• Phone: (203) 932-5711
• Email: gihyun.yoon[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• Intranasal insulin
Subjects in this arm will receive intranasal insulin (80 IU per day).
• Placebo
Subjects in this arm will receive placebo.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	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