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NMDA Receptor Antagonist
Written Exposure Therapy + Ketamine for Post-Traumatic Stress Disorder
Phase 2
Waitlist Available
Led By Adriana Feder, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Post Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CAPS-5
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketamine and Written Exposure TherapyExperimental Treatment2 Interventions
Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Written Exposure Therapy
2021
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,751 Total Patients Enrolled
Adriana Feder, MD5.02 ReviewsPrincipal Investigator - Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
145 Total Patients Enrolled
Oneysha Brown, BAStudy DirectorDepression and Anxiety Center, Icahn School of Medicine at Mount Sinai
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Eligibility Criteria:
This trial includes the following eligibility 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.Your weight is very high for your height (BMI over 40).Your estimated intelligence level is below 80.You are considered to be at a high risk of harming yourself or someone else.You are currently receiving specific types of therapy for post-traumatic stress disorder (PTSD), such as prolonged exposure or cognitive processing therapy.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.Female participants must either not be able to become pregnant or use reliable birth control methods. If using birth control pills, they must also use a barrier method.Women who can become pregnant must take a pregnancy test at the beginning and before each intravenous treatment to make sure they are not pregnant.You have had seizures in the past without a clear reason for them.You have been diagnosed with bipolar disorder in the past.You have been diagnosed with post-traumatic stress disorder (PTSD) by a study psychiatrist and your recent symptoms score is high enough to show moderate to severe PTSD symptoms.You have been given ketamine or esketamine before, but it didn't work for you.You have experienced hallucinations or have been diagnosed with a mental disorder like schizophrenia or schizoaffective disorder.You have had a problem with drugs or alcohol in the past three months.You have used ketamine or PCP for fun more than once, or you have used ketamine or PCP recreationally within the past two years.You are a man or woman between the ages of 18 and 70.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine and Written Exposure Therapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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