Depressive Disorder, MajorPhase 3NCT03674671
Ketamine Versus Electroconvulsive Therapy in Depression
A Phase 3 study testing Intravenous Ketamine and Electroconvulsive Therapy in people with Depressive Disorder, Major and Bipolar Depression, run by University of Ottawa at 4 sites in Canada.
Trial summary
While there are effective treatments for depression available, some patients do not see results with these options. Often, these patients are referred to electroconvulsive therapy (ECT) which has drawbacks such as adverse side effects, cost, and limited access. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major, Bipolar Depression
- What is being tested?
- Intravenous Ketamine and Electroconvulsive Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesCanada
- Study dates
- 29 Oct 2018to Dec 2025
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent before initiation of any study-related procedures.
- Eligible subjects who have consented to standard ECT treatment for their mood disorder and are willing to accept randomization to either ECT or IV ketamine group.
- Men and women aged between 18 and 70 years, inclusive with a body mass index (BMI) < 35. They must have a Montreal Cognitive Assessment (MOCA) score ≥ 24.
- Patients meeting criteria for Major Depressive Disorder (MDD) or Bipolar Disorder (BP) without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) currently in a Major Depressive Episode (MDE) as confirmed by the MINI International Neuropsychiatric Interview (MINI).
- A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and at randomization, with no more than 20% improvement between these two visits.
- Female subjects of childbearing potential must have a negative urine pregnancy test at enrolment (Visit 1) and be willing to use a reliable method of birth control (i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during the study.
- Abstain from consuming grapefruit juice (a potent 3A4 cytochrome inhibitor) on the day of the ketamine infusions as it may slow down the elimination of ketamine.
- Be able to understand and comply with the requirements of the study, as judged by the investigator(s).
Who cannot join
- Depression secondary to stroke, cancer or other severe medical illnesses.
- Prior or current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in DSM-5 criteria ("a problematic pattern of using alcohol or another substance that results in impairment in daily life or noticeable distress").
- A positive toxicology screen for drugs that are not prescribed.
- Unwilling to maintain current antidepressant regimen.
- Unwilling or unable to hold benzodiazepines from the evening prior to the infusion of ketamine.
- Unwilling to discontinue any narcotic for a minimum of 5 drug half-lives prior to injections.
Show all 40Show fewer
- Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the study.
- Evidence of clinically relevant disease, e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease (myocardial infarct within a year prior to initial randomization), cerebrovascular disease, history of cerebrovascular accident, viral hepatitis B or C, acquired immunodeficiency syndrome.
- A clinical finding that is unstable or that, in the opinion of the investigator(s), would be negatively affected by the study medication or that would affect the study medication (e.g., diabetes mellitus, hypertension, unstable angina).
- Liver function tests AST and ALT three times the upper normal limit at screening.
- Uncorrected hypothyroidism or hyperthyroidism. Subjects needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for 30 days prior to enrolment (Visit 1).
- Clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator(s). Including:
- Sodium under 135 or over 145 mmol/L
- Potassium under 3.5 or over 5.0 mmol/L
- Chloride under 98 or over 106 mmol/L
- ALT under 17 or over 63 U/L
- AST under 18 or over 40 U/L
- Total bilirubin over 26 mmol/L
- GGT under 9 or over 48 U/L
- Fasting glucose under 3.3 or over 5.8 mmol/L
- BUN under 2.5 or over 8.0 mmol/L
- Creatinine under 50 or over 90 mmol/L in females, and under 70 or over 120 mmol/L in males
- TSH under 0.4 or over 5.0 mU/L
- CBC indicating:
- Hemoglobin under 123 or over 157 g/L in females, and under 130 or over 170 g/L in males
- Hematocrit under 0.370 or over 0.460 in females, and under 0.380 or over 0.50 in males
- RBC under 4.0 or over 5.2x1012/L in females and under 4.4 or over 5.7x1012/L in males
- MCV under 80 or over 100 fL
- WBC under 4 or over 10x109/L
- Neutrophil over 0.7x109/L
- Lymphocyte under 1.0 or over 4.0x109/L
- Monocyte under 0.1 or over 1.0x109/L
- Eosinophil over 0.45x109/L
- Basophils over 0.10x109/L
- Platelets under 130 or over 400x109/L
- ECG results considered clinically significant as determined by the investigator(s), or outside of normal range as per cardiologist analysis.
- History of seizure disorder, except febrile convulsions.
- Known history of intolerance or hypersensitivity to ketamine.
- Any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measure.
- Note: active suicidal intent in MDD with the absence of psychotic symptoms is not an exclusion criterion).
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Providence Care Hospital
Kingston, Ontario, K7M 9A7
Royal Ottawa Mental Health Centre
Ottawa, Ontario, K1Z 7K4
University Health Network
Toronto, Ontario, M5G 1J6
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, L1N 5S9
About this study
Official title: Investigations on the Efficacy of Ketamine in Depression in Comparison to Electroconvulsive Therapy
While there are effective treatments for depression available, some patients do not see results with these options. Often, these patients are referred to electroconvulsive therapy (ECT) which has drawbacks such as adverse side effects, cost, and limited access. Recent research shows that intravenous ketamine may be an alternative option for these patients due to its rapid antidepressant effect sustained with multiple treatments.
This study will recruit 240 participants from the ECT waiting list at the five participating hospitals, and randomize them to either the ketamine or ECT treatment arm. Participants in the ketamine treatment arm will receive 0.5mg/kg ketamine intravenously (IV) over 40 minutes as described in the study schedule. Participants in the ECT treatment arm will receive ECT as described in the study schedule and as decided by their treating physician. Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted.
The aim of this study is to show that compared to ECT, ketamine treatment produces faster results, has less side effects, requires less or shorter hospitalizations, and is less expensive. The measures collected throughout the study (clinician scales, self-reports, blood samples, and neuroimaging) may help with predicting if future patients will respond to ECT or ketamine. This could lead to faster, more effective treatment for patient with depression.
Read the detailed description
Worldwide, depression carries a significant burden. Although there are effective treatments for depression, many patients do not achieve remission, and any significant response usually occurs after a few weeks. The common approach for a rapid intervention in cases of severe depressive symptoms has been electroconvulsive therapy (ECT). There are drawbacks to ECT including a prior medical work-up, general anaesthesia, and the possibility of memory loss. Further, access to ECT is often limited. Comparatively, the most striking breakthrough in the field of mood disorders has been the rapid antidepressant effects of intravenous ketamine. The antidepressant response to ketamine often occurs within a few hours, and peaks within 24. Recent studies have documented that the benefits of ketamine can be sustained with repeated administration.
This longitudinal, multi-centre, randomized, crossover clinical trial is funded in part by the Ontario Brain Institute through a sponsorship with the Canadian Biomarker Integration Network in Depression (CAN-BIND) research program. It will take place across five sites: the Royal Ottawa Mental Health Centre (lead site), Douglas Mental Health University Institute, Providence Care Hospital, Sunnybrook Health Sciences Centre and University Health Network.
A total of 240 participants (accounting for 20% dropout) will be recruited over 30 months from ECT wait lists across the five sites and randomized to either the ketamine or ECT treatment arm. Participants in the ketamine treatment arm will receive 0.5 mg/kg IV over 40 minutes in the recovery room of the ECT clinic as per the study schedule. Participants in the ECT treatment arm will receive ECT as per the study schedule and as decided by their treating physician. Each participant will be enrolled in the study for between six weeks and nine months, or until they leave the study or the study is terminated.
Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted. Data will be collected using the Ontario Brain Institute's Centre for Ontario Data Exploration and Research Electronic Data Capture in order to coordinate data from the five sites.
Participants randomized to the either treatment arm will receive thrice weekly treatments for 3 or 4 weeks for a total of 9 or 12 treatments respectively. Following the randomization phase, responders may move to the maintenance phase and non-responders may move to the crossover phase where they will receive the alternate therapy. During the crossover phase, participants will receive thrice weekly treatments for 3 or 4 weeks for a total of 9 or 12 treatments respectively. Following the crossover phase, responders will move to the maintenance phase and non-responders will exit the study. During the maintenance phase, participants who achieved response with ketamine will receive weekly ketamine treatments for one month, treatment once every two weeks for two months, and monthly treatment for three months. Should participants in the ketamine arm relapse during monthly treatment, they may return to treatments once every two weeks. Participants who achieved response in the ECT arm will receive ECT treatment for six months based on decision of the treating physician in order to maintain a clinical response. Both treatment arms will have a follow-up visit during month seven.
The aim of this study is to show that compared to ECT, ketamine treatment produces faster therapeutic action, has less side effects, requires fewer/shorter hospitalizations for patients, and will be less expensive because it does not require an anaesthesiologist and a psychiatrist to administer the various ECT protocols. Through the discovery of biomarkers to predict ECT or ketamine response or non-response, the anticipated effective treatment could be administered as a first line intervention for a subgroup of depressed patients, thereby ensuring a more time-efficient intervention.
- Conditions
- Depressive Disorder, Major, Bipolar Depression
- Being tested
- Intravenous Ketamine, Electroconvulsive Therapy
- Keywords
- Depression, MDD, neuroimaging, biomarkers, genomics, proteomic, BP
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous KetamineDrug
Also called Ketalar
Participants will receive 0.5mg/kg IV over 40 minutes, thrice weekly for 3 or 4 weeks. If participant responds, they will receive infusions weekly for one month, once every two weeks for two months, and once every month for three months. Should participant relapse during once monthly dosing, they may return to dosing once every two weeks for the remainder of the study.
Electroconvulsive TherapyProcedure or surgery
Also called ECT
Participants will receive ECT treatment thrice weekly for the 3 or 4 weeks. If participant responds, they will continue to receive ECT, with frequency at the discretion of the treating physician based on best practice guidelines for the remainder of the study.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Ketamine | Experimental | Not described Receives: Drug: Intravenous Ketamine |
| Electroconvulsive Therapy | Active comparator | Not described Receives: Procedure: Electroconvulsive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale
Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline.
- Remission: MADRS ≤ 10
- Response: >50% reduction in MADRS from baseline and a score <22
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start29 Oct 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: insufficient funding
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 Depressive Disorder, MajorStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Queen's University, University Health Network, Toronto, Ontario Shores Centre for Mental Health Sciences
- Responsible party
- Principal investigator, Pierre Blier, University of Ottawa
- Investigators
- Pierre Blier, MD, PhD, Principal investigator, The Royal's Institute of Mental Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674671
- Sponsor's protocol ID
- REB2018007
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2018
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is funded by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g. 21 CRF Part 11, HIPPA, PIPEDA) processes for securing privacy of healthcare data.
Publications
Phillips JL, Jaworska N, Kamler E, Bhat V, Blier J, Foster JA, Hassel S, Ho K, McMurray L, Milev R, Moazamigoudarzi Z, Placenza FM, Richard-Devantoy S, Rotzinger S, Turecki G, Vazquez GH, Kennedy SH, Blier P; CAN-BIND Investigator Team. A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol. BMC Psychiatry. 2020 Jun 2;20(1):268. doi: 10.1186/s12888-020-02672-3.
PubMed 32487236
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations on the Efficacy of Ketamine in Depression in Comparison to Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT03674671
- Acronym / sponsor ID
- REB2018007
- Conditions
- Depressive Disorder, Major, Bipolar Depression
- Keywords
- Depression, MDD, neuroimaging, biomarkers, genomics, proteomic, BP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: insufficient funding
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- McGill University, Queen's University, University Health Network, Toronto, Ontario Shores Centre for Mental Health Sciences
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Sep 2018 (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.
While there are effective treatments for depression available, some patients do not see results with these options. Often, these patients are referred to electroconvulsive therapy (ECT) which has drawbacks such as adverse side effects, cost, and limited access. Recent research shows that intravenous ketamine may be an alternative option for these patients due to its rapid antidepressant effect sustained with multiple treatments.
This study will recruit 240 participants from the ECT waiting list at the five participating hospitals, and randomize them to either the ketamine or ECT treatment arm. Participants in the ketamine treatment arm will receive 0.5mg/kg ketamine intravenously (IV) over 40 minutes as described in the study schedule. Participants in the ECT treatment arm will receive ECT as described in the study schedule and as decided by their treating physician. Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted.
The aim of this study is to show that compared to ECT, ketamine treatment produces faster results, has less side effects, requires less or shorter hospitalizations, and is less expensive. The measures collected throughout the study (clinician scales, self-reports, blood samples, and neuroimaging) may help with predicting if future patients will respond to ECT or ketamine. This could lead to faster, more effective treatment for patient with depression.
Detailed description
Worldwide, depression carries a significant burden. Although there are effective treatments for depression, many patients do not achieve remission, and any significant response usually occurs after a few weeks. The common approach for a rapid intervention in cases of severe depressive symptoms has been electroconvulsive therapy (ECT). There are drawbacks to ECT including a prior medical work-up, general anaesthesia, and the possibility of memory loss. Further, access to ECT is often limited. Comparatively, the most striking breakthrough in the field of mood disorders has been the rapid antidepressant effects of intravenous ketamine. The antidepressant response to ketamine often occurs within a few hours, and peaks within 24. Recent studies have documented that the benefits of ketamine can be sustained with repeated administration.
This longitudinal, multi-centre, randomized, crossover clinical trial is funded in part by the Ontario Brain Institute through a sponsorship with the Canadian Biomarker Integration Network in Depression (CAN-BIND) research program. It will take place across five sites: the Royal Ottawa Mental Health Centre (lead site), Douglas Mental Health University Institute, Providence Care Hospital, Sunnybrook Health Sciences Centre and University Health Network.
A total of 240 participants (accounting for 20% dropout) will be recruited over 30 months from ECT wait lists across the five sites and randomized to either the ketamine or ECT treatment arm. Participants in the ketamine treatment arm will receive 0.5 mg/kg IV over 40 minutes in the recovery room of the ECT clinic as per the study schedule. Participants in the ECT treatment arm will receive ECT as per the study schedule and as decided by their treating physician. Each participant will be enrolled in the study for between six weeks and nine months, or until they leave the study or the study is terminated.
Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted. Data will be collected using the Ontario Brain Institute's Centre for Ontario Data Exploration and Research Electronic Data Capture in order to coordinate data from the five sites.
Participants randomized to the either treatment arm will receive thrice weekly treatments for 3 or 4 weeks for a total of 9 or 12 treatments respectively. Following the randomization phase, responders may move to the maintenance phase and non-responders may move to the crossover phase where they will receive the alternate therapy. During the crossover phase, participants will receive thrice weekly treatments for 3 or 4 weeks for a total of 9 or 12 treatments respectively. Following the crossover phase, responders will move to the maintenance phase and non-responders will exit the study. During the maintenance phase, participants who achieved response with ketamine will receive weekly ketamine treatments for one month, treatment once every two weeks for two months, and monthly treatment for three months. Should participants in the ketamine arm relapse during monthly treatment, they may return to treatments once every two weeks. Participants who achieved response in the ECT arm will receive ECT treatment for six months based on decision of the treating physician in order to maintain a clinical response. Both treatment arms will have a follow-up visit during month seven.
The aim of this study is to show that compared to ECT, ketamine treatment produces faster therapeutic action, has less side effects, requires fewer/shorter hospitalizations for patients, and will be less expensive because it does not require an anaesthesiologist and a psychiatrist to administer the various ECT protocols. Through the discovery of biomarkers to predict ECT or ketamine response or non-response, the anticipated effective treatment could be administered as a first line intervention for a subgroup of depressed patients, thereby ensuring a more time-efficient intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Ketamine | Experimental | Drug: Intravenous Ketamine |
| Electroconvulsive Therapy | Active comparator | Procedure: Electroconvulsive Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of written informed consent before initiation of any study-related procedures.
- Eligible subjects who have consented to standard ECT treatment for their mood disorder and are willing to accept randomization to either ECT or IV ketamine group.
- Men and women aged between 18 and 70 years, inclusive with a body mass index (BMI) < 35. They must have a Montreal Cognitive Assessment (MOCA) score ≥ 24.
- Patients meeting criteria for Major Depressive Disorder (MDD) or Bipolar Disorder (BP) without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) currently in a Major Depressive Episode (MDE) as confirmed by the MINI International Neuropsychiatric Interview (MINI).
- A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and at randomization, with no more than 20% improvement between these two visits.
Key exclusion criteria (40 listed)
- Depression secondary to stroke, cancer or other severe medical illnesses.
- Prior or current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in DSM-5 criteria ("a problematic pattern of using alcohol or another substance that results in impairment in daily life or noticeable distress").
- A positive toxicology screen for drugs that are not prescribed.
- Unwilling to maintain current antidepressant regimen.
- Unwilling or unable to hold benzodiazepines from the evening prior to the infusion of ketamine.
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 |
|---|---|---|
| Intravenous KetamineAlso: KetalarParticipants will receive 0.5mg/kg IV over 40 minutes, thrice weekly for 3 or 4 weeks. If participant responds, they will receive infusions weekly for one month, once every two weeks for two months, and once every month for three months. Should participant relapse during once monthly dosing, they may return to dosing once every two weeks for the remainder of the study. | Drug | Intravenous Ketamine |
| Electroconvulsive TherapyAlso: ECTParticipants will receive ECT treatment thrice weekly for the 3 or 4 weeks. If participant responds, they will continue to receive ECT, with frequency at the discretion of the treating physician based on best practice guidelines for the remainder of the study. | Procedure or surgery | Electroconvulsive Therapy |
Primary outcome
Montgomery-Asberg Depression Rating Scale
Time frame: 3-4 weeks
Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline. * Remission: MADRS ≤ 10 * Response: >50% reduction in MADRS from baseline and a score <22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 32487236Phillips JL, Jaworska N, Kamler E, Bhat V, Blier J, Foster JA, Hassel S, Ho K, McMurray L, Milev R, Moazamigoudarzi Z, Placenza FM, Richard-Devantoy S, Rotzinger S, Turecki G, Vazquez GH, Kennedy SH, Blier P; CAN-BIND Investigator Team. A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol. BMC Psychiatry. 2020 Jun 2;20(1):268. doi: 10.1186/s12888-020-02672-3.
- Individual participant dataSharing planned: Yes. This study is funded by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g. 21 CRF Part 11, HIPPA, PIPEDA) processes for securing privacy of healthcare data.
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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.
Pierre Blier, MD, PhD principal investigator
The Royal's Institute of Mental Health Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Ketamine and Electroconvulsive Therapy in people with Depressive Disorder, Major and Bipolar Depression, run by University of Ottawa at 4 sites 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 8 inclusion and 40 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: paused, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Montgomery-Asberg Depression Rating Scale (time frame: 3-4 weeks). 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 NCT03674671, 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 1 Sep 2023.