Intranasal Insulin for Posttraumatic Stress Disorder

VA Connecticut Healthcare System

Status and phase: Enrolling; Phase 2

Conditions: PTSD

Treatments: Drug: Placebo; Drug: Intranasal insulin

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04044534

GY0005

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Intranasal insulin

Experimental group

Description:

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

Treatment:

Drug: Intranasal insulin

Placebo

Experimental group

Description:

Subjects in this arm will receive placebo.

Treatment:

Drug: Placebo