Treatment Resistant DepressionNCT04695405
Pharmacogenetics Associated With IV Ketamine
An observational study of Treatment Resistant Depression, 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 treatment resistant depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Saliva Genetic Samples
- Type of treatment
- Injection or infusion
- How many people
- 85 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2021to 2 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All participants will have received IV ketamine previously for treatment resistant depression, as defined by the DSM-5
Who may be able to join
- Must have received IV ketamine previously to treat Treatment-Resistant Depression
- Between the ages of 18-65 years old.
- Clinical diagnosis of MDD
- Individuals may have had comorbid psychiatric conditions (e.g., anxiety), but the comorbid psychiatric condition cannot be the primary clinical concern.
- Ability to provide informed consent
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 currently experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
- Individuals who are unable to consent to the procedure.
- Individuals who are unable to adhere to the protocol in its totality
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: Genetic Markers Associated With Response to Intravenous Ketamine
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 treatment resistant depression. Patients who have received IV ketamine at the clinic are eligible to participate in this study where genetic biomarkers are correlated with response to IV ketamine.
- Conditions
- Treatment Resistant Depression
- Being tested
- Saliva Genetic Samples
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva Genetic SamplesGenetic
Patients will provide two saliva swabs containing genetic materials.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Resistant Depression | Patients, who previously received intravenous ketamine, will be asked to provide genetic samples in order to assess relationships between response and genetic markers. Receives: Genetic: Saliva Genetic Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic Biomarkers
Genetic markers associated with metabolism of IV ketamine will be assessed
Measured: 1 month
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 1-2 weeks
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 1-2 weeks
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 1-2 weeks
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 initial infusions
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 1-2 weeks
Secondary outcomes (7)
Work Productivity and Activity Impairment Questionnaire (WPAI)
WPAI is a questionnaire used to evaluate lost productivity due to depression. scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Measured: 1 month
Mystical Experience Questionnaire (MEQ)
Mystical Experience Questionnaire (MEQ) is a self-report measure that has been used to assess the effects of hallucinogens in laboratory studies. Some studies suggest that mysticism may be associated with a response to ketamine. The MEQ is a 30 item questionnaire, with each item ranging from 0 to 5. A higher score denotes a strong mystical experience.
Measured: 1 month
Childhood Trauma Questionnaire (CTQ)
The CTQ assesses five types of childhood trauma: 1)Emotional neglect 2) physical abuse 3) emotional abuse 4)physical neglect 5) sexual abuse.
Each item being rated in 5 answer choice from 1 to 5 (never, rarely, sometimes, often or very often)
Measured: 1 month
UCLA Loneliness Scale (UCLA)
20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.
Measured: 1 month
Diet Screener Questionnaire
Captures data regarding an individuals dietary habits over the past month
Measured: 1 month
Quality of Life Questionnaire (EQ-3D-5L)
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health).
Measured: 1 month
Perceived Health Questionnaire (PHQ)
PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start21 Jan 2021
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies 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
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain and Cognition Discovery Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua D Rosenblat, MD, MSc, Principal investigator, Canadian Rapid Treatment Center of Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695405
- Sponsor's protocol ID
- Ket-PGx
- Status last verified
- Aug 2021
- First submitted
- 28 Dec 2020
- Last updated
- 18 Aug 2021
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Markers Associated With Response to Intravenous Ketamine
- ClinicalTrials.gov ID
- NCT04695405
- Acronym / sponsor ID
- Ket-PGx
- Conditions
- Treatment Resistant Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Brain and Cognition Discovery FoundationUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 5 Jan 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.
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 treatment resistant depression. Patients who have received IV ketamine at the clinic are eligible to participate in this study where genetic biomarkers are correlated with response to IV ketamine.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-Resistant Depression | – | Genetic: Saliva Genetic SamplesPatients, who previously received intravenous ketamine, will be asked to provide genetic samples in order to assess relationships between response and genetic markers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will have received IV ketamine previously for treatment resistant depression, as defined by the DSM-5
Key inclusion criteria (5 listed)
- Must have received IV ketamine previously to treat Treatment-Resistant Depression
- Between the ages of 18-65 years old.
- Clinical diagnosis of MDD
- Individuals may have had comorbid psychiatric conditions (e.g., anxiety), but the comorbid psychiatric condition cannot be the primary clinical concern.
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
- Individuals who are currently experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
- Individuals who are unable to consent to the procedure.
- Individuals who are unable to adhere to the protocol in its totality
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 |
|---|---|---|
| Saliva Genetic SamplesPatients will provide two saliva swabs containing genetic materials. | Genetic | Treatment-Resistant Depression |
Primary outcome
Genetic Biomarkers
Time frame: 1 month
Genetic markers associated with metabolism of IV ketamine will be assessed
Quick Inventory of Depressive Symptomatology Self Report 16-Item
Time frame: Over 1-2 weeks
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 1-2 weeks
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 1-2 weeks
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 initial infusions
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.
Clinician Administered Dissociative States Scale
Time frame: Over 1-2 weeks
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.
7 secondary outcomes
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 1 month
Mystical Experience Questionnaire (MEQ)
Time frame: 1 month
Childhood Trauma Questionnaire (CTQ)
Time frame: 1 month
UCLA Loneliness Scale (UCLA)
Time frame: 1 month
Diet Screener Questionnaire
Time frame: 1 month
Quality of Life Questionnaire (EQ-3D-5L)
Time frame: 1 month
Perceived Health Questionnaire (PHQ)
Time frame: 1 month
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 18 Aug 2021.
- 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.
Joshua D Rosenblat, MD, MSc principal investigator
Canadian Rapid Treatment Center of Excellence
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 Treatment Resistant Depression, 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 5 inclusion and 4 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 18 Aug 2021. 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?
Genetic Biomarkers (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2021.