NCT04771767

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

2.7 years

First QC Date

November 19, 2020

Last Update Submit

August 8, 2022

Conditions

Post-Traumatic Stress Disorder

Keywords

KetamineCognitive Behavioral TherapyOnline Cognitive Behavioral TherapyPharmacologically enhanced psychotherapy

Outcome Measures

Primary Outcomes (1)

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

    Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.

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

Secondary Outcomes (4)

  • Change in Scores on the Montgomery Asberg Depression Rating Scale

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

  • Change in Scores on the Columbia Suicide Severity Rating Scale

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

  • Change in Scores on the Sheehan Disabilities Scale

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

  • Change in Scores on the Global Assessment of Functioning

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

Study Arms (2)

Ketamine + eCBT

EXPERIMENTAL

Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine

Drug: KetamineBehavioral: Online Trauma-Focused Cognitive Behavioural Therapy

Control

NO 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.

Interventions

KetamineDRUG

Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.

Also known as: Ketalar
Ketamine + eCBT
Online Trauma-Focused Cognitive Behavioural TherapyBEHAVIORAL

Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.

Also known as: eCBT, TF-CBT
Ketamine + eCBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

RECRUITING

Related Publications (6)

  • Alavi N, Stefanoff M, Hirji A, Khalid-Khan S. Cognitive Behavioural Therapy through PowerPoint: Efficacy in an Adolescent Clinical Population with Depression and Anxiety. Int J Pediatr. 2018 Nov 8;2018:1396216. doi: 10.1155/2018/1396216. eCollection 2018.

    PMID: 30532790BACKGROUND

  • Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.

    PMID: 24740528BACKGROUND

  • Girgenti MJ, Ghosal S, LoPresto D, Taylor JR, Duman RS. Ketamine accelerates fear extinction via mTORC1 signaling. Neurobiol Dis. 2017 Apr;100:1-8. doi: 10.1016/j.nbd.2016.12.026. Epub 2016 Dec 30.

    PMID: 28043916BACKGROUND

  • Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.

    PMID: 24338345BACKGROUND

  • Pradhan B, Mitrev L, Moaddell R, Wainer IW. d-Serine is a potential biomarker for clinical response in treatment of post-traumatic stress disorder using (R,S)-ketamine infusion and TIMBER psychotherapy: A pilot study. Biochim Biophys Acta Proteins Proteom. 2018 Jul;1866(7):831-839. doi: 10.1016/j.bbapap.2018.03.006. Epub 2018 Mar 18.

    PMID: 29563072BACKGROUND

  • Philipp-Muller AE, Reshetukha T, Vazquez G, Milev R, Armstrong D, Jagayat J, Alavi N. Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 20;10(7):e30334. doi: 10.2196/30334.

    PMID: 34092549DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Taras Reshetukha, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron E Philipp-Muller, B.Sc.

CONTACT

416-939-316419aepm1@queensu.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants diagnosed with PTSD will be assigned either to the experimental treatment or a control. Data will be collected from participants in both groups at the same 4 time-points.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 19, 2020

First Posted

February 25, 2021

Study Start

August 1, 2021

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

All participant screening and assessment data will be made available once deidentified.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Made available in June 2024. No end date.
Access Criteria
Open access

Locations

CA(1)