What is the mechanism of action of this treatment?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacological options like ketamine and psychotherapeutic interventions such as Cognitive Behavioral Therapy (CBT). Ketamine acts through NMDA receptor antagonism, modulating glutamate neurotransmission, which can result in rapid alleviation of severe symptoms, including depression and suicidal ideation. This rapid action is particularly beneficial for PTSD patients in acute distress. CBT, particularly trauma-focused CBT, works by helping patients address and modify dysfunctional thoughts and behaviors related to their trauma, providing long-term coping mechanisms and facilitating recovery. Both treatments are essential as they offer complementary benefits: immediate symptom relief and sustainable long-term management.

What side effects are associated with this type of intervention?

Common treatments for PTSD include pharmacotherapy with SSRIs/SNRIs and psychotherapeutic interventions like Cognitive Behavioral Therapy (CBT). Ketamine, an NMDA receptor antagonist, is being studied for its rapid antidepressant effects but can cause side effects such as disorientation, restlessness, dissociation, dizziness, delirium, psychosis, nausea, vomiting, and increased blood pressure. Online CBT, a psychotherapeutic intervention, generally has fewer side effects, but may include temporary increases in anxiety or distress as patients confront traumatic memories. Both treatments aim to reduce PTSD symptoms but come with their respective side effect profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for PTSD, primarily focusing on pharmacological and psychotherapeutic interventions. Selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine are commonly prescribed and FDA-approved for PTSD. While Ketamine, an NMDA receptor antagonist, has shown promise in treating depression and is being studied for PTSD, it is not yet FDA-approved specifically for PTSD. Cognitive Behavioral Therapy (CBT), including exposure and response prevention (ERP), is a well-established psychotherapeutic intervention for PTSD, though it is not an FDA-regulated treatment. The combination of these approaches, such as the use of Ketamine with online CBT, represents an innovative area of ongoing research.

What other types of research exist?

Promising novel alternatives to Ketamine and Online Cognitive Behavioural Therapy for PTSD patients in 2024 include MDMA-assisted psychotherapy and psilocybin-assisted therapy. Both have shown potential in clinical trials for treating PTSD and other psychiatric conditions.

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NMDA Receptor Antagonist

Ketamine + eCBT for PTSD

Phase 2

Waitlist Available

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.

Must not have

Untreated hypertension

Treatment with Naltrexone

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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial tests a new treatment for PTSD using low-dose Ketamine infusions and online therapy. It targets patients who haven't improved with other treatments. Ketamine affects brain chemicals related to mood, while the therapy helps change negative thoughts. The goal is to see if this combination works better than other treatments. Ketamine is currently used in treating multiple pain, mental health, and substance abuse disorders due to its rapid-acting analgesic and antidepressant effects.

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have high blood pressure that hasn't been treated.

Select...

I am currently taking Naltrexone.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Scores on the Clinician Administered PTSD Scale for DSM-5

Secondary study objectives

Change in Scores on the Columbia Suicide Severity Rating Scale

Change in Scores on the Global Assessment of Functioning

Mental Depression

+1 more

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

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacological options like ketamine and psychotherapeutic interventions such as Cognitive Behavioral Therapy (CBT). Ketamine acts through NMDA receptor antagonism, modulating glutamate neurotransmission, which can result in rapid alleviation of severe symptoms, including depression and suicidal ideation. This rapid action is particularly beneficial for PTSD patients in acute distress. CBT, particularly trauma-focused CBT, works by helping patients address and modify dysfunctional thoughts and behaviors related to their trauma, providing long-term coping mechanisms and facilitating recovery. Both treatments are essential as they offer complementary benefits: immediate symptom relief and sustainable long-term management.