Treatment-resistant Depression (TRD)NCT05464264
Auditory MMN EEG in TRD in Response to Ketamine
An observational study of Treatment-resistant Depression (TRD), run by Unity Health Toronto at 1 site in Canada.
Trial summary
To develop and test a neurocomputational model of ketamine treatment response predictions in TRD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-resistant Depression (TRD)
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2022to Dec 2024
- 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: Patient participants diagnosed as suffering from a Treatment-Resistant Depression (TRD) that meet the criteria from Diagnosis and Statistical Manual for Mental Disorders (DSM-5), will be eligible to participate in this data collection study. Participants who have agreed to receive ketamine treatments as part of the Interventional Psychiatry Clinical Program at St. Michael's Hospital will be approached and recruited.
Who may be able to join
- 1.18 to 65 years of age 2. Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for MDD and in a Major Depressive Episode and ≥10 on the Montgomery-Asberg Depression Rating Scale (MADRS).
- 3. Competent to consent-based on their ability to provide a spontaneous narrative description of the key elements of the study.
- 4. Failure of at least two trials of antidepressant therapy during the current episode (treatment-resistant depression) and receiving ketamine treatment clinically as administered by their clinician 5. Staying on stable dosages of any concomitant psychotropic medications.
Who cannot join
- History of bipolar disorder or psychosis
- Current substance use or history of substance use during the past year (excluding nicotine and caffeine use disorder)
- Concomitant major and unstable medical or neurologic illness or a history of seizures.
- Non-English-speaking individuals.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1M8
Venkat Bhat, MD MSc, 4163604000 ext. 76404
Venkat Bhat, MD MSc
About this study
Official title: Deciphering Metacognition and Treatment Response in Depression With a Novel Digital Paradigm
To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.
Read the detailed description
The investigators propose applying a previously validated computational model of the MMN and the ensuing effects of NMDAR antagonism to predict treatment response following ketamine infusions in TRD patients and distinguish ketamine's antisuicidal effects from those related to mood improvements. The study has two subgoals: first, the computational mechanisms underlying MMN reductions that predict ketamine treatment response in TRD patients will be examined. Second, the computational mechanisms will be linked to their underlying neural causes using neural circuit models. Beyond understanding ketamine's short- and long-term mechanisms of action in TRD, the parameters obtained from fitting these models to noninvasive EEG recordings may facilitate single-patient treatment predictions. If successful, this approach may provide clinically useful prognostic statements in individual patients.
- Conditions
- Treatment-resistant Depression (TRD)
- Being tested
- Ketamine
- 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.
KetamineDrug
Participants suffering from TRD will receive their ketamine treatment intravenously twice weekly for two weeks (4 treatments in total). A dose of 0.5 mg/kg is infused over 40 minutes, with dose adjustments made at the psychiatrist's discretion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Remission, defined as MADRS <10, and suicide risk reduction is defined as a ≥ 50% reduction in the suicidal ideation item of the MADRS scale from baseline
Measured: 4 weeks following the baseline visit
Secondary outcomes (1)
Modelling
Modelling the underlying cognitive and behavioural mechanisms to their neural causes from the effect of ketamine on TRD patients
Measured: 2 weeks following the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start3 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant Depression (TRD)Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Toronto Metropolitan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464264
- Sponsor's protocol ID
- 22-084
- Status last verified
- Nov 2023
- First submitted
- 24 Jun 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin J, Gholamali Nezhad F, Rueda A, Lee GH, Charlton CE, Soltanzadeh M, Ladha KS, Krishnan S, Diaconescu AO, Bhat V. Predicting treatment response to ketamine in treatment-resistant depression using auditory mismatch negativity: Study protocol. PLoS One. 2024 Aug 8;19(8):e0308413. doi: 10.1371/journal.pone.0308413. eCollection 2024.
PubMed 39116153
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering Metacognition and Treatment Response in Depression With a Novel Digital Paradigm
- ClinicalTrials.gov ID
- NCT05464264
- Acronym / sponsor ID
- 22-084
- Conditions
- Treatment-resistant Depression (TRD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Toronto Metropolitan University
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Jul 2022 (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.
To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.
Detailed description
The investigators propose applying a previously validated computational model of the MMN and the ensuing effects of NMDAR antagonism to predict treatment response following ketamine infusions in TRD patients and distinguish ketamine's antisuicidal effects from those related to mood improvements. The study has two subgoals: first, the computational mechanisms underlying MMN reductions that predict ketamine treatment response in TRD patients will be examined. Second, the computational mechanisms will be linked to their underlying neural causes using neural circuit models. Beyond understanding ketamine's short- and long-term mechanisms of action in TRD, the parameters obtained from fitting these models to noninvasive EEG recordings may facilitate single-patient treatment predictions. If successful, this approach may provide clinically useful prognostic statements in individual patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient participants diagnosed as suffering from a Treatment-Resistant Depression (TRD) that meet the criteria from Diagnosis and Statistical Manual for Mental Disorders (DSM-5), will be eligible to participate in this data collection study. Participants who have agreed to receive ketamine treatments as part of the Interventional Psychiatry Clinical Program at St. Michael's Hospital will be approached and recruited.
Key inclusion criteria (3 listed)
- 1.18 to 65 years of age 2. Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for MDD and in a Major Depressive Episode and ≥10 on the Montgomery-Asberg Depression Rating Scale (MADRS).
- 3. Competent to consent-based on their ability to provide a spontaneous narrative description of the key elements of the study.
- 4. Failure of at least two trials of antidepressant therapy during the current episode (treatment-resistant depression) and receiving ketamine treatment clinically as administered by their clinician 5. Staying on stable dosages of any concomitant psychotropic medications.
Key exclusion criteria (4 listed)
- History of bipolar disorder or psychosis
- Current substance use or history of substance use during the past year (excluding nicotine and caffeine use disorder)
- Concomitant major and unstable medical or neurologic illness or a history of seizures.
- Non-English-speaking individuals.
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 |
|---|---|---|
| KetamineParticipants suffering from TRD will receive their ketamine treatment intravenously twice weekly for two weeks (4 treatments in total). A dose of 0.5 mg/kg is infused over 40 minutes, with dose adjustments made at the psychiatrist's discretion. | Drug | – |
Primary outcome
Clinical remission
Time frame: 4 weeks following the baseline visit
Remission, defined as MADRS <10, and suicide risk reduction is defined as a ≥ 50% reduction in the suicidal ideation item of the MADRS scale from baseline
1 secondary outcome
Modelling
Time frame: 2 weeks following the baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 39116153Martin J, Gholamali Nezhad F, Rueda A, Lee GH, Charlton CE, Soltanzadeh M, Ladha KS, Krishnan S, Diaconescu AO, Bhat V. Predicting treatment response to ketamine in treatment-resistant depression using auditory mismatch negativity: Study protocol. PLoS One. 2024 Aug 8;19(8):e0308413. doi: 10.1371/journal.pone.0308413. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
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 (TRD), run by Unity Health Toronto 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 3 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Venkat Bhat, MD MSc (416-360-4000 ext. 76404, Venkat.Bhat@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: 4 weeks following the baseline visit). 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 NCT05464264, which also lists 1 linked publication.
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 29 Nov 2023.