Major Depressive DisorderNCT04209296
Chart Review of Patients Undergoing Ketamine Infusions
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Brain and Cognition Discovery Foundation at 1 site in Canada.
Trial summary
The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from mental health conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Obsessive-Compulsive Disorder
- What is being tested?
- Ketamine Hydrochloride
- How many people
- 891 participants
- Where
- 1 siteCanada
- Study dates
- 3 Dec 2019to 14 Sep 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The investigators aim to analyze data from June 2018 (clinic opening) to present. Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD), Bipolar Disorder (BD), Post-Traumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD) as determined by a psychiatrist. Patients must currently be experiencing a major depressive episode (MDE) as defined by the DSM-5.
Who may be able to join
- Over the age of 18 years old. Patients over the age of 65 must receive additional approval to ensure safety.
- Diagnosed with either MDD, BD, PTSD or OCD by a healthcare provider.
- Experiencing an MDE as defined and operationalized in the DSM 5.0.
- Individuals who may have comorbid psychiatric conditions, but the comorbid psychiatric condition can be neither the primary condition or the primary clinical concern.
- Individuals reporting suicidal ideation will be included, as suicidal ideation is a symptom of MDE.
- Individuals must have received at least 2 guideline concordant treatment trials with pharmacotherapeutic treatment options as suggested in the CANMAT MDD guidelines 2016, Florida Medicaid guidelines 2017, or the CANMAT ISBD guidelines for BD 2013.
- Individuals who have received ECT or other neuromodulatory treatments will be eligible for ketamine infusion.
Who cannot join
- Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
- Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
- Individuals who are unable to consent to the treatment.
- Individuals who are unable to adhere to the protocol in its totality (i.e., remain in the clinic post infusion for up to 2-3 hours for observation).
- Individuals who are unable to identify a person to assure their safe transport home following ketamine infusion.
- Individuals with symptomatic traumatic brain injury.
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- Uncontrolled medical disorders (i.e., uncontrolled and/or insufficiently treated hypertension, allergies to ketamine and/or previous intolerability of ketamine).
- Pregnancy.
- Medical contraindications to ketamine.
- Patients that are over 275 lbs
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canadian Rapid Treatment Centre of Excellence
Mississauga, Ontario, L5C 4E7
About this study
Official title: A Retrospective Chart Review of Patients Undergoing Ketamine Infusions at the Canadian Rapid Treatment Center of Excellence
The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from mental health conditions. The center focuses specifically on treating individuals suffering from major depression disorder, bipolar disorder, post-traumatic stress disorder and obsessive compulsive disorder as their primary diagnosis. Herein, this retrospective analysis aims to look at past data in order to further develop our understanding of ketamine in the use of psychiatry.
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Obsessive-Compulsive Disorder, Post Traumatic Stress Disorder
- Being tested
- Ketamine Hydrochloride
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Obsessive-Compulsive Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder (MDD) | DSM-5 Diagnosis of MDD Receives: Drug: Ketamine Hydrochloride | |
| Bipolar Disorder | DSM-5 Diagnosis of Bipolar Disorder Receives: Drug: Ketamine Hydrochloride | |
| Obsessive Compulsive Disorder (OCD) | DSM-5 Diagnosis of OCD Receives: Drug: Ketamine Hydrochloride | |
| Post-traumatic Stress Disorder (PTSD) | DSM-5 Diagnosis of PTSD Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology Self Report 16-Item
The QIDS-SR16 is a self-report assessment used to evaluate depression severity in patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of Major Depressive Episode. In total, there are 16 individual questions evaluating 9 DSM domains. The highest score is 27, indicating severe depression, while the lowest score is 0, which would suggest a complete absence of depressive symptoms.
Measured: Over 4 inital infusions and maintance infusions (~2 years)
Generalized Anxiety Disorder 7-item
The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety. The scale ranges from 0 (not at all) to 3 (nearly every day). To total score ranges from 0 suggesting a lack anxiety symptoms to 21, indicating severe anxiety.
Measured: Over 4 inital infusions and maintance infusions (~2 years)
Snaith-Hamilton Pleasure Scale
The SHAPS assessment is a 14 item self report tool used to measure anhedonia. Each item can be have a response of 1 (Definitely agree), 2(Agree), 3(Disagree), and 4(definitely disagree). The total score ranges from 14 to 56, in which higher scores on the assessment indicate higher levels of anhedonia.
Measured: Over 4 inital infusions and maintance infusions (~2 years)
Sheehan Disability Scale
The SDS contains 3 items, each ranging between zero to ten. The SDS is a self-reported assessment of disability within the context of depression. The total score ranges from 0, indicating no impairment, to 30, indicating severe impairment.
Measured: Over 4 inital infusions and maintance infusions (~2 years)
Endicott Work Productivity Scale
The EWPS is a self report scale consisting of 25 items each ranging from 0 (high functioning) to 4 (low functioning). The total score ranges from 0 to 100, with 100 indicating extremely poor workplace productivity.
Measured: Over 4 inital infusions and maintance infusions (~2 years)
Secondary outcomes (1)
Clinician Administered Dissociative States Scale
The CADSS is a 23-item assessment administered by a clinician in order to evaluate dissociative symptoms. Each item is evaluated on a scale from 0, suggesting no dissociative symptom, to 4, suggesting extreme dissociation. In total, patients can score between 0 to 92, indicating extreme dissociation.
Measured: Over 4 inital infusions and maintance infusions (~2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start3 Dec 2019
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major Depressive 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain and Cognition Discovery Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger McIntyre, Brain and Cognition Discovery Foundation
- Investigators
- Roger S McIntyre, MD, Principal investigator, Brain and Cognition Discovery Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209296
- Sponsor's protocol ID
- Pro00040593
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2019
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality. Only aggregate data will be published or made available.
Publications
Chisamore N, Danayan K, Rodrigues NB, Di Vincenzo JD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, McIntyre RS, Rosenblat JD. Real-world effectiveness of repeated intravenous ketamine infusions for treatment-resistant depression in transitional age youth. J Psychopharmacol. 2023 Aug;37(8):775-783. doi: 10.1177/02698811231171531. Epub 2023 May 16.
PubMed 37194253Danayan K, Chisamore N, Rodrigues NB, Vincenzo JDD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, Teopiz KM, McIntyre RS, Rosenblat JD. Real world effectiveness of repeated ketamine infusions for treatment-resistant depression with comorbid borderline personality disorder. Psychiatry Res. 2023 May;323:115133. doi: 10.1016/j.psychres.2023.115133. Epub 2023 Mar 5.
PubMed 36889160McIntyre RS, Rosenblat JD, Rodrigues NB, Lipsitz O, Chen-Li D, Lee JG, Nasri F, Subramaniapillai M, Kratiuk K, Wang A, Gill H, Mansur RB, Ho R, Lin K, Lee Y. The effect of intravenous ketamine on cognitive functions in adults with treatment-resistant major depressive or bipolar disorders: Results from the Canadian rapid treatment center of excellence (CRTCE). Psychiatry Res. 2021 Aug;302:113993. doi: 10.1016/j.psychres.2021.113993. Epub 2021 May 13.
PubMed 34034067Lipsitz O, McIntyre RS, Rodrigues NB, Kaster TS, Cha DS, Brietzke E, Gill H, Nasri F, Lin K, Subramaniapillai M, Kratiuk K, Teopiz K, Lui LMW, Lee Y, Ho R, Shekotikhina M, Mansur RB, Rosenblat JD. Early symptomatic improvements as a predictor of response to repeated-dose intravenous ketamine: Results from the Canadian Rapid Treatment Center of Excellence. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110126. doi: 10.1016/j.pnpbp.2020.110126. Epub 2020 Oct 5.
PubMed 33031861
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review of Patients Undergoing Ketamine Infusions at the Canadian Rapid Treatment Center of Excellence
- ClinicalTrials.gov ID
- NCT04209296
- Acronym / sponsor ID
- Pro00040593
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Obsessive-Compulsive Disorder, Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 891 participants (actual)
- Lead sponsor
- Brain and Cognition Discovery FoundationUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 24 Dec 2019 (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.
The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from mental health conditions. The center focuses specifically on treating individuals suffering from major depression disorder, bipolar disorder, post-traumatic stress disorder and obsessive compulsive disorder as their primary diagnosis. Herein, this retrospective analysis aims to look at past data in order to further develop our understanding of ketamine in the use of psychiatry.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder (MDD) | – | Drug: Ketamine HydrochlorideDSM-5 Diagnosis of MDD |
| Bipolar Disorder | – | Drug: Ketamine HydrochlorideDSM-5 Diagnosis of Bipolar Disorder |
| Obsessive Compulsive Disorder (OCD) | – | Drug: Ketamine HydrochlorideDSM-5 Diagnosis of OCD |
| Post-traumatic Stress Disorder (PTSD) | – | Drug: Ketamine HydrochlorideDSM-5 Diagnosis of PTSD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to analyze data from June 2018 (clinic opening) to present. Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD), Bipolar Disorder (BD), Post-Traumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD) as determined by a psychiatrist. Patients must currently be experiencing a major depressive episode (MDE) as defined by the DSM-5.
Key inclusion criteria (7 listed)
- Over the age of 18 years old. Patients over the age of 65 must receive additional approval to ensure safety.
- Diagnosed with either MDD, BD, PTSD or OCD by a healthcare provider.
- Experiencing an MDE as defined and operationalized in the DSM 5.0.
- Individuals who may have comorbid psychiatric conditions, but the comorbid psychiatric condition can be neither the primary condition or the primary clinical concern.
- Individuals reporting suicidal ideation will be included, as suicidal ideation is a symptom of MDE.
Key exclusion criteria (10 listed)
- Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
- Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
- Individuals who are unable to consent to the treatment.
- Individuals who are unable to adhere to the protocol in its totality (i.e., remain in the clinic post infusion for up to 2-3 hours for observation).
- Individuals who are unable to identify a person to assure their safe transport home following ketamine infusion.
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 |
|---|---|---|
| Ketamine HydrochlorideKetamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine. | Drug | Bipolar Disorder, Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Post-traumatic Stress Disorder (PTSD) |
Primary outcome
Quick Inventory of Depressive Symptomatology Self Report 16-Item
Time frame: Over 4 inital infusions and maintance infusions (~2 years)
The QIDS-SR16 is a self-report assessment used to evaluate depression severity in patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of Major Depressive Episode. In total, there are 16 individual questions evaluating 9 DSM domains. The highest score is 27, indicating severe depression, while the lowest score is 0, which would suggest a complete absence of depressive symptoms.
Generalized Anxiety Disorder 7-item
Time frame: Over 4 inital infusions and maintance infusions (~2 years)
The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety. The scale ranges from 0 (not at all) to 3 (nearly every day). To total score ranges from 0 suggesting a lack anxiety symptoms to 21, indicating severe anxiety.
Snaith-Hamilton Pleasure Scale
Time frame: Over 4 inital infusions and maintance infusions (~2 years)
The SHAPS assessment is a 14 item self report tool used to measure anhedonia. Each item can be have a response of 1 (Definitely agree), 2(Agree), 3(Disagree), and 4(definitely disagree). The total score ranges from 14 to 56, in which higher scores on the assessment indicate higher levels of anhedonia.
Sheehan Disability Scale
Time frame: Over 4 inital infusions and maintance infusions (~2 years)
The SDS contains 3 items, each ranging between zero to ten. The SDS is a self-reported assessment of disability within the context of depression. The total score ranges from 0, indicating no impairment, to 30, indicating severe impairment.
Endicott Work Productivity Scale
Time frame: Over 4 inital infusions and maintance infusions (~2 years)
The EWPS is a self report scale consisting of 25 items each ranging from 0 (high functioning) to 4 (low functioning). The total score ranges from 0 to 100, with 100 indicating extremely poor workplace productivity.
1 secondary outcome
Clinician Administered Dissociative States Scale
Time frame: Over 4 inital infusions and maintance infusions (~2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 37194253Chisamore N, Danayan K, Rodrigues NB, Di Vincenzo JD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, McIntyre RS, Rosenblat JD. Real-world effectiveness of repeated intravenous ketamine infusions for treatment-resistant depression in transitional age youth. J Psychopharmacol. 2023 Aug;37(8):775-783. doi: 10.1177/02698811231171531. Epub 2023 May 16.
- Derived from this study: PubMed 36889160Danayan K, Chisamore N, Rodrigues NB, Vincenzo JDD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, Teopiz KM, McIntyre RS, Rosenblat JD. Real world effectiveness of repeated ketamine infusions for treatment-resistant depression with comorbid borderline personality disorder. Psychiatry Res. 2023 May;323:115133. doi: 10.1016/j.psychres.2023.115133. Epub 2023 Mar 5.
- Derived from this study: PubMed 34034067McIntyre RS, Rosenblat JD, Rodrigues NB, Lipsitz O, Chen-Li D, Lee JG, Nasri F, Subramaniapillai M, Kratiuk K, Wang A, Gill H, Mansur RB, Ho R, Lin K, Lee Y. The effect of intravenous ketamine on cognitive functions in adults with treatment-resistant major depressive or bipolar disorders: Results from the Canadian rapid treatment center of excellence (CRTCE). Psychiatry Res. 2021 Aug;302:113993. doi: 10.1016/j.psychres.2021.113993. Epub 2021 May 13.
- Derived from this study: PubMed 33031861Lipsitz O, McIntyre RS, Rodrigues NB, Kaster TS, Cha DS, Brietzke E, Gill H, Nasri F, Lin K, Subramaniapillai M, Kratiuk K, Teopiz K, Lui LMW, Lee Y, Ho R, Shekotikhina M, Mansur RB, Rosenblat JD. Early symptomatic improvements as a predictor of response to repeated-dose intravenous ketamine: Results from the Canadian Rapid Treatment Center of Excellence. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110126. doi: 10.1016/j.pnpbp.2020.110126. Epub 2020 Oct 5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality. Only aggregate data will be published or made available.
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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.
Roger S McIntyre, MD principal investigator
Brain and Cognition Discovery Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Brain and Cognition Discovery Foundation 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 12 Aug 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology Self Report 16-Item (time frame: Over 4 inital infusions and maintance infusions (~2 years)). The study lists 5 primary outcomes in all. 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 NCT04209296, which also lists 4 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 12 Aug 2024.