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Could a nasal spray boost PTSD therapy? early trial hints at possibility

NCT ID NCT06795659

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small study tested whether adding esketamine (a nasal spray approved for depression) to prolonged exposure therapy could help people with PTSD. Four adults completed 10 daily therapy sessions over two weeks while receiving esketamine. The main goal was to see if the combination was feasible and acceptable, not to prove it works. Early results suggest it may be worth studying further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Esketamine (nasal spray)
What this could lead to
If this combination works, it could point toward a faster, more effective way to treat PTSD by enhancing the benefits of therapy.
What could go wrong
This was a very small, early-stage trial with only 4 participants, so results may not apply to others. The study focused on feasibility, not proof of effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

4 people

The number who actually took part.

Started

Jun 2025

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Individual between the ages of 18-65 years old (Young adults \[18 to 24 years old\] must not be taking an antidepressant). 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5) 3. Able to speak and read English (due to standardization of outcome measures) 4. On stable doses of current medications for at least 4 weeks 5. Weigh between 50-100 kg (110-220 pounds). Exclusion Criteria: 1. Young adults (18-24) currently taking any antidepressant. 2. Lifetime history of psychotic disorder or history of significant psychotic symptoms. 3. Lifetime history of manic episode. 4. Moderate or greater severity for alcohol or substance use disorder (DSM-5) in the previous six months. 5. A history of ketamine or phencyclidine abuse. 6. Evidence of a traumatic brain injury severe enough to interfere with comprehension and responding to the baseline screening questionnaires. 7. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider) 8. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment. 9. Current use (with past 4 weeks) of any prohibited concomitant medications 10. Benzodiazepines, other medications, sedatives, acute alcohol use, or recreational drug use that would put patients at risk in the judgment of clinical providers). 11. Planned use of ketamine (i.e., for pain control) or participation in another trauma-focused psychotherapy during the time of the study. 12. Uncontrolled hypertension or tachycardia 13. A history of sensitivity or adverse reaction to ketamine or its excipients 14. An unstable medical, cardiovascular, pulmonary, or neurological condition that the investigator considers a contraindication to ketamine administration 15. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. 16. Intracerebral hemorrhage. 17. Pregnancy or breastfeeding; women of childbearing potential unwilling to utilize reliable methods of contraception 18. History of nasal surgery or nasal obstructions experienced as an adult. 19. Inability to arrange for assisted transportation on ketamine treatment days due to recommendation that patient not drive for the remainder of the day following a ketamine treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.