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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 13 weeks
Awards & highlights
Study Summary
This trial will test whether adding a brief, 5-session written trauma-focused therapy to a course of repeated IV ketamine infusions can prolong PTSD symptom improvement.
Eligible Conditions
- Post Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CAPS-5
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
Written Exposure Therapy
2021
Completed Phase 2
~370
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
863 Previous Clinical Trials
525,598 Total Patients Enrolled
Oneysha Brown, BAStudy DirectorDepression and Anxiety Center, Icahn School of Medicine at Mount Sinai
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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the government's opinion on Ketamine?
"Ketamine has received a 2. This is due to the lack of data regarding Ketamine's efficacy, despite there being some evidence supporting its safety as a medication."
Answered by AI
Are there any patients participating in this research right now?
"Yes, the website clinicaltrials.gov indicates that this trial is still enrolling patients. The study was originally posted on June 4th 2021 and updated as recently as August 5th, 2022."
Answered by AI
Might I be able to help with this research by enrolling in it?
"This clinical trial is seeking 30 individuals aged 18-70 who have moral injury and meet the following additional criteria: • Must be able to identify a family member, physician, or friend who will agree to the Treatment Contract (which includes contacting the study physician in case of manic symptoms or suicidal thoughts) • Must fulfill DSM-5 criteria for current civilian or combat-related PTSD, based on clinical assessment by a study psychiatrist and on the CAPS-5. A past-month total CAPS5 score ≥ 25 at screening is required to ensure at least moderate severity and reduce high placebo response rates. •"
Answered by AI
Are elderly patients barred from participating in this research?
"In order to meet the requirements for this clinical trial, potential patients must 18 years old or older, but cannot be more than 70."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
Ive tried many other drugs to minimal success.
PatientReceived 2+ prior treatments
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