Post-Traumatic Stress DisorderPhase 2NCT04771767
Combined Ketamine and eCBT Intervention for PTSD
A Phase 2 study testing Ketamine and Online Trauma-Focused Cognitive Behavioural Therapy in people with Post-Traumatic Stress Disorder, run by Queen's University at 1 site in Canada.
Trial summary
An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Ketamine and Online Trauma-Focused Cognitive Behavioural Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2021to 31 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Queen's University
Kingston, Ontario, K7L 3N6
Aaron Philipp-Muller, B.Sc., 4169393164, 19aepm1@queensu.ca
About this study
Official title: Assessing a Combined Ketamine and Online Cognitive Behavioural Therapy Intervention for Treatment Resistant Post-Traumatic Stress Disorder
An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.
Read the 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, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 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 control.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Ketamine, Online Trauma-Focused Cognitive Behavioural Therapy
- Keywords
- Ketamine, Cognitive Behavioral Therapy, Online Cognitive Behavioral Therapy, Pharmacologically enhanced psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
Online Trauma-Focused Cognitive Behavioural TherapyBehavioural
Also called eCBT, TF-CBT
Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ketamine; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.
Measured: 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
Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.
Measured: 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
A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.
Measured: 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
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.
Measured: 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Aug 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Taras Reshetukha, Queen's University
- Investigators
- Taras Reshetukha, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771767
- Sponsor's protocol ID
- 14521759
- Status last verified
- Aug 2022
- First submitted
- 19 Nov 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant screening and assessment data will be made available once deidentified.
Publications
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.
PubMed 30532790Feder 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.
PubMed 24740528Girgenti 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.
PubMed 28043916Bisson 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.
PubMed 24338345Pradhan 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.
PubMed 29563072Philipp-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.
PubMed 34092549
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Combined Ketamine and Online Cognitive Behavioural Therapy Intervention for Treatment Resistant Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04771767
- Acronym / sponsor ID
- 14521759
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Ketamine, Cognitive Behavioral Therapy, Online Cognitive Behavioral Therapy, Pharmacologically enhanced psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 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 control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine + eCBT | Experimental | Drug: Ketamine, Behavioral: Online Trauma-Focused Cognitive Behavioural TherapyOver 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: KetalarPatients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes. | Drug | Ketamine + eCBT |
| Online Trauma-Focused Cognitive Behavioural TherapyAlso: eCBT, TF-CBTParticipants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT. | Behavioural | Ketamine + eCBT |
Primary outcome
Change in Scores on the Clinician Administered PTSD Scale for DSM-5
Time frame: 0 weeks from start, 4 weeks from start, 8 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.
4 secondary outcomes
Change in Scores on the Montgomery Asberg Depression Rating Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Background: PubMed 30532790Alavi 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.
- Background: PubMed 24740528Feder 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.
- Background: PubMed 28043916Girgenti 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.
- Background: PubMed 24338345Bisson 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.
- Background: PubMed 29563072Pradhan 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.
- Derived from this study: PubMed 34092549Philipp-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.
- Individual participant dataSharing planned: Yes. All participant screening and assessment data will be made available once deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taras Reshetukha, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Online Trauma-Focused Cognitive Behavioural Therapy in people with Post-Traumatic Stress Disorder, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aaron E Philipp-Muller, B.Sc. (416-939-3164, 19aepm1@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scores on the Clinician Administered PTSD Scale for DSM-5 (time frame: 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771767, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.