PTSDPhase 2NCT04044534

Intranasal Insulin for Posttraumatic Stress Disorder

A Phase 2 study testing Intranasal insulin in people with PTSD, run by VA Connecticut Healthcare System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate if intranasal insulin is effective in reducing PTSD symptoms. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: PTSD
What is being tested?: Intranasal insulin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2024to 28 May 2026
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

VA Connecticut Healthcare System
West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Intranasal Insulin for Treating Posttraumatic Stress Disorder

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

Read the 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.

Conditions: PTSD
Being tested: Intranasal insulin, Placebo
Keywords: Intranasal insulin, PTSD
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intranasal insulinDrug
Subjects in this arm will receive intranasal insulin (80 IU per day).
PlaceboDrug
Subjects in this arm will receive placebo.

Study groups in NCT04044534
Study group	Role	What they receive
Intranasal insulin	Experimental	Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day). Receives: Drug: Intranasal insulin
Placebo	Experimental	Subjects in this arm will receive placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202428 May 2026

First posted5 Aug 2019
Study start31 Oct 2024
Primary completion28 May 2026
Study completion28 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PTSDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04044534
Sponsor's protocol ID: GY0005
Status last verified: Jun 2026
First submitted: 1 Aug 2019
Last updated: 13 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intranasal Insulin for Treating Posttraumatic Stress Disorder
ClinicalTrials.gov ID: NCT04044534
Acronym / sponsor ID: GY0005
Conditions: PTSD
Keywords: Intranasal insulin, PTSD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: VA Connecticut Healthcare SystemUS federal agency
Study start: 31 Oct 2024 (actual)
Primary completion: 28 May 2026 (actual)
Study completion: 28 May 2026 (actual)
First posted: 5 Aug 2019 (actual)
Results: Posted 13 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intranasal insulin	Experimental	Drug: Intranasal insulinSubjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
Placebo	Experimental	Drug: PlaceboSubjects in this arm will receive placebo.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intranasal insulinSubjects in this arm will receive intranasal insulin (80 IU per day).	Drug	Intranasal insulin
PlaceboSubjects in this arm will receive placebo.	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 13 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants (Crossover)	6	6

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

Time frame: 1 week. Mean (Standard Deviation). Unit: score on a scale

Measure	Intranasal Insulin n = 6	Placebo n = 6
Value	-7.33 (12.08)	-7.00 (9.21)

Intranasal Insulin vs Placebo: p = 0.965, t-test, 2 sided

Adverse events

Time frame: 1 week per intervention phase. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intranasal Insulin	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Placebo	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for PTSD

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The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gihyun Yoon, MD principal investigator

VA Connecticut Healthcare System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intranasal insulin in people with PTSD, run by VA Connecticut Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD Symptoms on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) From Pre- to Post-Intervention (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04044534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.