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Ketamine for Post-Traumatic Stress Disorder

Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai, Manhattan, NY
Post-Traumatic Stress DisorderKetamine - Drug
Eligibility
18 - 70
All Sexes

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: up to 12 weeks

up to 12 weeks
CAPS-5

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
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.

Trial Design

1 Treatment Group

Ketamine and Written Exposure Therapy
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Ketamine · No Placebo Group · Phase 2

Ketamine and Written Exposure TherapyExperimental Group · 2 Interventions: Ketamine, Written Exposure Therapy · Intervention Types: Drug, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Written Exposure Therapy
2020
N/A
~330

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 weeks

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
800 Previous Clinical Trials
509,486 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

Eligibility Criteria

Age 18 - 70 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a man or woman between the ages of 18 and 70.
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.
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.
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.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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. •" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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