Intranasal Insulin for Posttraumatic Stress Disorder

NCT ID: NCT04044534

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intranasal insulin

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

Group Type EXPERIMENTAL

Intranasal insulin

Intervention Type DRUG

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

Placebo

Subjects in this arm will receive placebo.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Subjects in this arm will receive placebo.

Interventions

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Intranasal insulin

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

Intervention Type DRUG

Placebo

Subjects in this arm will receive placebo.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Connecticut Healthcare System

FED

Sponsor Role lead

Responsible Party

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Gihyun Yoon, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gihyun Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gihyun Yoon, MD

Role: CONTACT

(203) 932-5711 ext. 7421

Facility Contacts

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Gihyun Yoon, MD

Role: primary

203-932-5711 ext. 7421

Other Identifiers

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GY0005

Identifier Type: -

Identifier Source: org_study_id

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