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Combined Ketamine and eCBT Intervention for PTSD

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ClinicalTrials.gov Identifier: NCT04771767
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Taras Reshetukha, Queen's University

Tracking Information
First Submitted Date  ICMJE November 19, 2020
First Posted Date  ICMJE February 25, 2021
Last Update Posted Date September 21, 2021
Actual Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
Change in Scores on the Clinician Administered PTSD Scale for DSM-5 [ Time Frame: 0 weeks from start, 7 weeks from start, and 14 weeks from start ]
Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2021)
Change in Scores on the Clinician Administered PTSD Scale for DSM-5 [ Time Frame: 0 weeks from start, 6 weeks from start, and 12 weeks from start ]
Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
  • Change in Scores on the Montgomery Asberg Depression Rating Scale [ Time Frame: 0 weeks from start, 7 weeks from start, and 14 weeks from start ]
    Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.
  • Change in Scores on the Columbia Suicide severity scale [ Time Frame: 0 weeks from start, 7 weeks from start, and 14 weeks from start ]
    Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.
  • Change in Scores on the Clinical Global Impressions Severity and Improvement Scale [ Time Frame: 0 weeks from start, 7 weeks from start, and 14 weeks from start ]
    Measures a clinicians overall gestalt impression of a patient's clinical severity; score representing the mildest/lack of symptoms: 1; score representing the most severe symptoms: 7.
  • Change in Scores on the Sheehan Disabilities Scale [ Time Frame: 0 weeks from start, 7 weeks from start, and 14 weeks from start ]
    A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.
  • Change in Scores on the Global Assessment of Functioning [ Time Frame: 0 weeks from start, 7 weeks from start, and 14 weeks from start ]
    Assessing the patient's overall capacity to handle life's challenges; score representing the mildest/lack of symptoms: 100; score representing the most severe symptoms: 1.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2021)
  • Change in Scores on the Montgomery Asberg Depression Rating Scale [ Time Frame: 0 weeks from start, 6 weeks from start, and 12 weeks from start ]
    Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.
  • Change in Scores on the Columbia Suicide severity scale [ Time Frame: 0 weeks from start, 6 weeks from start, and 12 weeks from start ]
    Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.
  • Change in Scores on the Clinical Global Impressions Severity and Improvement Scale [ Time Frame: 0 weeks from start, 6 weeks from start, and 12 weeks from start ]
    Measures a clinicians overall gestalt impression of a patient's clinical severity; score representing the mildest/lack of symptoms: 1; score representing the most severe symptoms: 7.
  • Change in Scores on the Sheehan Disabilities Scale [ Time Frame: 0 weeks from start, 6 weeks from start, and 12 weeks from start ]
    A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.
  • Change in Scores on the Global Assessment of Functioning [ Time Frame: 0 weeks from start, 6 weeks from start, and 12 weeks from start ]
    Assessing the patient's overall capacity to handle life's challenges; score representing the mildest/lack of symptoms: 100; score representing the most severe symptoms: 1.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Ketamine and eCBT Intervention for PTSD
Official Title  ICMJE Assessing a Combined Ketamine and Online Cognitive Behavioural Therapy Intervention for Treatment Resistant Post-Traumatic Stress Disorder
Brief Summary An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.
Detailed Description

OBJECTIVES

(i) To introduce a previously untreated patient population with PTSD to new therapeutic options.

(ii) To provide new insights into the functional role of Glutamate in affective disorders as well as in learning and memory.

(iii) To explore the utility of pharmacologically-enhanced psychotherapy.

OUTLINE

The present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic IV Ketamine in conjunction with online CBT (eCBT). In the study, 20 participants with refractory PTSD will be randomly assigned either to an experimental group receiving a combination of Ketamine and eCBT over 14 weeks, or they will be assigned to a 14-week waitlist-control group (at the end of which they would receive the experimental treatment). Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at the 7-week halfway point, and at the end of the 14 week experimental period. Symptoms of PTSD and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the waitlist-control.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants diagnosed with PTSD will be randomly assigned either to the experimental treatment or a waitlist control. Data will be collected from participants in both groups at the same 3 time-points.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE
  • Drug: Ketamine
    Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
    Other Name: Ketalar
  • Behavioral: Online Trauma-Focused Cognitive Behavioural Therapy
    Participants will enrol in a 14-week online CBT program mirroring in-person trauma-focused CBT.
    Other Names:
    • eCBT
    • TF-CBT
Study Arms  ICMJE
  • Experimental: Ketamine + eCBT
    Over 14 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine
    Interventions:
    • Drug: Ketamine
    • Behavioral: Online Trauma-Focused Cognitive Behavioural Therapy
  • No Intervention: Waitlist-Control
    Participants are on a waitlist during which time they will not receive the experimental treatment and will have no change in their treatment regimen. These patients will receive the experimental treatment after their participation in the experiment is complete.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aaron E Philipp-Muller, B.Sc. 416-939-3164 19aepm1@queensu.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04771767
Other Study ID Numbers  ICMJE 14521759
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All participant screening and assessment data will be made available once deidentified.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Made available in June 2022. No end date.
Access Criteria: Open access
Responsible Party Dr. Taras Reshetukha, Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Taras Reshetukha, MD Queen's University
PRS Account Queen's University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP