Written Exposure Therapy + Ketamine for Post-Traumatic Stress Disorder

Overseen By Oneysha Brown, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial combines writing therapy and ketamine injections to help people with chronic PTSD who don't fully benefit from current treatments. Ketamine makes the brain more adaptable, and writing about trauma helps reduce its emotional impact. Ketamine has shown benefits for treating PTSD symptoms and is being explored in combination with psychotherapy for lasting effects.

Research Team

Oneysha Brown, BA

Principal Investigator

Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai

Adriana Feder, MD

Principal Investigator

Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document

You need to have someone close to you who can sign a contract agreeing to contact the study doctor if you experience thoughts of suicide or manic symptoms.

Women must be using a medically accepted reliable means of contraception (if using an oral contraceptive medication, they must also be using a barrier contraceptive) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year)

Exclusion Criteria

You have a history of a condition that affects the development of your brain, like autism or a pervasive developmental disorder.

You have been diagnosed with bulimia nervosa or anorexia nervosa.

Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG

Treatment Details

Interventions

• Ketamine
• Written Exposure Therapy

Participant Groups

Group I: Ketamine and Written Exposure Therapy Experimental Treatment 2 Interventions

Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy

Ketamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+