16 Participants Needed

Written Exposure Therapy + Ketamine for Post-Traumatic Stress Disorder

OB
Overseen ByOneysha Brown, BA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

OB

Oneysha Brown, BA

Principal Investigator

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

AF

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)
See 9 more

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
See 18 more

Treatment Details

Interventions

  • Ketamine
  • Written Exposure Therapy
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Ketamine and Written Exposure TherapyExperimental Treatment2 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:

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Approved in United States as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
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Approved in European Union as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
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Approved in United States as Spravato for:
  • Treatment-resistant depression
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Approved in European Union as Spravato for:
  • Treatment-resistant depression
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Approved in Canada as Spravato for:
  • Treatment-resistant depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+