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Unknown statusPhase 2

Combined Ketamine and eCBT Intervention for PTSD

NCT04771767 · Queen's University

Closed to entry
Status
Not accepting participants
Phase 2
Phase
16
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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. * 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. * Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate. * Participants must speak and read English, and will have consistent and reliable access to the internet. * Patients with suicidal ideation will be included. * Patients with a history of substance abuse will be included (except for opioid use disorder). Exclusion Criteria: Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.

Where

1 study site

FacilityCityRegionCountry
Queen's UniversityKingstonOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04771767 on ClinicalTrials.gov →

Last updated in the registry 2022-08-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits