Intranasal Insulin for Posttraumatic Stress Disorder

Phase 2

Recruiting

• Conditions: PTSD
• Interventions: Drug: Placebo; Drug: Intranasal insulin

• Registration Number: NCT04044534
• Lead Sponsor: VA Connecticut Healthcare System

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Status Verified: 2024-10
• Study Start: 2024-10-31
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects in this arm will receive placebo.
Intranasal insulin	Intranasal insulin	Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).

Primary Outcome Measures

Name	Time	Method
Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	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).

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States