Intranasal Insulin for Posttraumatic Stress Disorder

NCT04044534 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GY0005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PTSD

Keywords

Intranasal insulin; PTSD

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 week

Study Arms (2)

Intranasal insulin

EXPERIMENTAL

Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).

Drug: Intranasal insulin

Placebo

EXPERIMENTAL

Subjects in this arm will receive placebo.

Drug: Placebo

Interventions

Intranasal insulin DRUG

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

Intranasal insulin

Placebo DRUG

Subjects in this arm will receive placebo.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 21-65 years old
• Current PTSD
• Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Gihyun Yoon, MD
• Organization: VA Connecticut Healthcare System

gihyun.yoon@yale.edu

(203) 932-5711

Study Officials

• Gihyun Yoon, MD

  VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: October 31, 2024
• Primary Completion: May 28, 2026
• Study Completion: May 28, 2026
• Last Updated: July 13, 2026
• Results First Posted: July 13, 2026

Record last verified: 2026-06

Locations

US (1)