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NMDA Receptor Antagonist
Ketamine + eCBT for PTSD
Phase 2
Recruiting
Led By Taras Reshetukha, MD
Research Sponsored by Queen's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms.
Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Awards & highlights
Study Summary
This trial is testing whether a combination of Ketamine and online Cognitive Behavioural Therapy is effective for treating PTSD.
Who is the study for?
This trial is for adults with PTSD who have tried at least two treatments without much improvement. They must speak English, have internet access, and stable treatment if they have hypertension or heart disease. People with bipolar disorder, psychosis, opioid use disorder, certain untreated conditions or those pregnant or breastfeeding cannot join.Check my eligibility
What is being tested?
The study tests a combination of Ketamine infusions and online Cognitive Behavioural Therapy (CBT) to treat PTSD. It's an open label RCT where participants know what treatment they're getting and are chosen by chance to receive either the combined therapy or another condition.See study design
What are the potential side effects?
Ketamine may cause confusion, hallucinations, changes in blood pressure and nausea. Online CBT is generally safe but can sometimes lead to temporary increases in distress as difficult topics are discussed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had 2 treatments that didn't reduce my symptoms by half.
Select...
I have been diagnosed with PTSD by a psychiatrist, with a moderate severity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Scores on the Clinician Administered PTSD Scale for DSM-5
Secondary outcome measures
Change in Scores on the Columbia Suicide Severity Rating Scale
Change in Scores on the Global Assessment of Functioning
Mental Depression
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine + eCBTExperimental Treatment2 Interventions
Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine
Group II: ControlActive Control1 Intervention
Participants are in a control condition receiving treatment as usual, during which time they will not receive the experimental treatment and will have no change in their treatment regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Queen's UniversityLead Sponsor
365 Previous Clinical Trials
120,401 Total Patients Enrolled
Taras Reshetukha, MDPrincipal InvestigatorQueen's University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had 2 treatments that didn't reduce my symptoms by half.I have high blood pressure that hasn't been treated.I am on a stable treatment plan for my high blood pressure or heart disease.I am currently taking Naltrexone.I have a heart condition.I have been diagnosed with PTSD by a psychiatrist, with a moderate severity.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine + eCBT
- Group 2: Control
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.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04771767 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical study permit individuals below the age of 75 to participate?
"This trial requires that participants be between 18 and 65 years of age. In addition, there are 58 clinical trials catering to minors and 410 for seniors."
Answered by AI
Does my background and health history meet the criteria for participating in this medical experiment?
"The trial is recruiting 16 individuals aged 18 to 65 suffering from stress-related disorders and trauma. To qualify, their symptoms must have been assessed using the CAPS-5 test by a psychiatrist on the team with score of at least 50, they should have received two unsuccessful prior treatments, those with hypertension or cardiovascular disease should be under stable treatment, patients presenting suicidal ideation may join as well as those battling substance abuse (except for opioid use disorder)."
Answered by AI
How many participants have signed up for this clinical experiment?
"Affirmative. Per the data yielded from clinicaltrials.gov, this trial is actively seeking participants and was first posted on August 1st 2021. The current goal is to recruit a total of 16 patients across one site before the study's last update on 8th August 2022."
Answered by AI
Are there potential health risks with Ketamine usage?
"There is some evidence of Ketamine's safety, so it was adjudged a 2 on the scale. However, no data exists to support its efficacy at this time."
Answered by AI
Does this medical trial have any vacancies for participants?
"Clinicaltrials.gov attests that this clinical trial is open for patient recruitment, with the initial post dating back to August 1st 2021 and a recent edit made on the 8th of August 2022."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Ontario
Alberta
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Queen's University
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have severe treatment resistant depression, and nothing has worked in years. Maybe this would work? I'm willing to try a lot of things at this point and I'm based in kingston for the time being so kind of perfect.
PatientReceived no prior treatments
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