Depression - Major Depressive DisorderNCT07099235
Chart Review of Patients Undergoing Ketamine Treatments for Depression
An observational study of Depression - Major Depressive Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The Ontario Ketamine and Infusion Centre (OKIC) is a CPSO-certified Level-II OHP and an outpatient centre for intravenous ketamine treatments for treatment-resistant depression. This retrospective, observational study aims to conduct a chart review on patients receiving ketamine in a naturalistic setting to develop… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- ketamine hydrochloride
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 29 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with treatment-resistant depression receiving an induction phase of intravenous ketamine treatments at the OKIC from clinic opening (April 1, 2022) to June 29, 2025.
Who may be able to join
- Age ≥ 18
- Able to provide informed consent
- Patient diagnosed with treatment-resistant depression
- Outpatient recommended and approved by psychiatrist for ketamine treatment
- Individuals who have previously received ECT, rTMS or any other neuromodulation can also receive ketamine
Who cannot join
- History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist
- Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment
- History of substance misuse and/or dependence, including chronic alcohol abuse
- Previous ketamine use
- Acute dementia/delirium
- Pregnancy/breastfeeding
Show all 10Show fewer
- Previous sensitivity to ketamine or related compounds
- Unstable medical condition which may require anesthesia consult
- History of elevated intracranial pressure or cerebrovascular accident
- Recent (within 6 weeks) major cardiovascular event (such as myocardial infarction)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ontario Ketamine and Infusion Centre - Toronto Site
Mississauga, Ontario, L4Y 1M3
About this study
Official title: Retrospective Chart Review of Patients Undergoing Intravenous Ketamine Treatments for Treatment-resistant Depression
The Ontario Ketamine and Infusion Centre (OKIC) is a CPSO-certified Level-II OHP and an outpatient centre for intravenous ketamine treatments for treatment-resistant depression. This retrospective, observational study aims to conduct a chart review on patients receiving ketamine in a naturalistic setting to develop our understanding of ketamine as an interventional approach for treatment-resistant depression.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- ketamine hydrochloride
- Keywords
- Ketamine, Major Depressive Disorder, Retrospective
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine hydrochlorideDrug
Racemic ketamine is a 50/50 mixture of enantiomers (S)-ketamine and (R)-ketamine. The repeated administration of racemic ketamine intravenously at subanesthetic doses has emerged as an efficacious treatment for treatment-resistant depression.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-resistant Major Depressive Disorder (MDD); DSM-5 Diagnosis of MDD | Not described Receives: Drug: ketamine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 item
The PHQ-9 is a 9 item self-report assessment used to evaluate symptoms of depression. Each item has a response of 0 (None at all), 1 (Several days), 2 (More than half the days), and 3 (Nearly every day). The scale ranges from 0-27, with higher scores indicating greater severity of depression symptoms.
Measured: Treatment Day 1 to Day 8, an average of 4 weeks.
Beck's Depression Inventory-II
The BDI-II is a 21-item self-report assessment used to evaluate symptoms of depression. Each item is scored form 0-3, with a higher score representing more severe depression. The total score ranges from 0-63, with a score >29 indicating severe depression.
Measured: Treatment Day 1 to Day 8, an average of 4 weeks.
Generalized Anxiety Disorder-7 item
The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety. Each item has a response of 0 (Not at all), 1 (Several days), 2 (More than half the days), and 3 (Nearly every day). The scale ranges from 0-21, with higher scores indicating greater severity of anxiety symptoms.
Measured: Treatment Day 1 to Day 8, an average of 4 weeks.
Secondary outcomes (8)
Antidepressant Treatment History Form: Short Form
The Antidepressant Treatment History Form: Short Form (ATHF-SF) is a clinician-scored form to assess the adequacy of antidepressant treatment trials in the context of treatment-resistant depression. The form collects information regarding history of standard antidepressant medications use, such as SSRIs, SNRIs, TCAs, as well as neuromodulation and psychotherapy approaches. Previous treatments are checked off in a box, with more boxes checked meaning greater level of treatment resistance.
Measured: Baseline
Adverse childhood experiences-10 item
The Adverse childhood experiences-10 item (ACE-10) questionnaire is a 10-item self-report assessment used to evaluate a history of adverse childhood experiences in one's life. Each item is a distinct category of an adverse childhood experience, and the 10 items are typically organized into larger categories of abuse, neglect, and family dysfunction. With a minimum score of 0 and maximum score of 10, higher scores indicate having a greater quantity of adverse childhood experiences.
Measured: Baseline
Primary care PTSD screen for DSM-5
The PC-PTSD-5 is a 5-item self-report assessment used to screen for probable PTSD within a primary care setting. Each item has a response option of 'Yes' or 'No.' The total score is the number of 'Yes' responses to the questions. A score of 0-3 indicates low probability of PTSD and 4 or more indicates probable PTSD.
Measured: Baseline
Multidimensional Scale of Perceived Social Support scale
The MSPSS is a 12-item self-report assessment used to evaluate an individual's perceived level of social support. Each item has 7 response options: 1 (Very strongly disagree); 2 (Strongly disagree); 3 (Mildly disagree); 4 (Neutral); 5 (Mildly agree); 6 (Strongly agree); 7 (Very strongly agree). The score ranges from 12-84, with higher scores indicating higher levels of perceived social support.
Measured: Baseline
Subject Assessment of Memory Impairment
The SAMI is a brief 2-part self-report assessment used to evaluate self-assessed extent of memory impairment. Part 1 asks to rate memory problems on a scale of 0-10, with 0 indicating no memory problems and 10 indicating very severe memory problems. Part 2 asks to rate the impact of these problems on their work and social activities on a scale of 1-5; 1 indicating no complaints and normal activity, and 5 indicating the symptoms to radically change their normal work and social activities.
Measured: Baseline
Personal Inventory for Depression and Seasonal Affective Disorder
The PIDS is a 6-item self-report assessment used to evaluate seasonal affective disorder. Each item has a response of 0 (no change), 1 (slight change), 2 (moderate change), 3 (marked change), 4 (extreme change). Higher scores indicate a greater change in behaviors or feelings with the seasons.
Measured: Baseline
Quick Inventory of Depressive Symptomatology-Self Report
The QIDS-SR is a 16-item self-report assessment used to evaluate symptoms of depression. The scoring range is from 0-27, with higher scores indicating more severe symptoms of depression.
Measured: Baseline
Family history of psychiatric conditions and neurological conditions
Family history of health and psychiatric conditions is collected in a form with conditions alongside columns with family relationship. Individuals indicate the diagnosis of a relative for the relevant condition/ disorder by a checkmark in the appropriate box. Family history is collected for the following conditions: depression, bipolar disorder, schizophrenia, psychotic illnesses, anxiety disorder, substance abuse, suicide attempt, completed suicide, seizures, dementia, and other brain disorders.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Apr 2022
- Primary completion29 Jun 2025
- Study completion29 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fahad Alam, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099235
- Sponsor's protocol ID
- 6828
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Individual data sharing
- No: Due to patient confidentiality, individual participant data will not be shared. Only aggregate data will be published or made available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review of Patients Undergoing Intravenous Ketamine Treatments for Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT07099235
- Acronym / sponsor ID
- 6828
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Ketamine, Major Depressive Disorder, Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 29 Jun 2025 (actual)
- First posted
- 1 Aug 2025 (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 Ontario Ketamine and Infusion Centre (OKIC) is a CPSO-certified Level-II OHP and an outpatient centre for intravenous ketamine treatments for treatment-resistant depression. This retrospective, observational study aims to conduct a chart review on patients receiving ketamine in a naturalistic setting to develop our understanding of ketamine as an interventional approach for treatment-resistant depression.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-resistant Major Depressive Disorder (MDD); DSM-5 Diagnosis of MDD | – | Drug: ketamine hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with treatment-resistant depression receiving an induction phase of intravenous ketamine treatments at the OKIC from clinic opening (April 1, 2022) to June 29, 2025.
Key inclusion criteria (5 listed)
- Age ≥ 18
- Able to provide informed consent
- Patient diagnosed with treatment-resistant depression
- Outpatient recommended and approved by psychiatrist for ketamine treatment
- Individuals who have previously received ECT, rTMS or any other neuromodulation can also receive ketamine
Key exclusion criteria (10 listed)
- History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist
- Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment
- History of substance misuse and/or dependence, including chronic alcohol abuse
- Previous ketamine use
- Acute dementia/delirium
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 hydrochlorideRacemic ketamine is a 50/50 mixture of enantiomers (S)-ketamine and (R)-ketamine. The repeated administration of racemic ketamine intravenously at subanesthetic doses has emerged as an efficacious treatment for treatment-resistant depression. | Drug | Treatment-resistant Major Depressive Disorder (MDD); DSM-5 Diagnosis of MDD |
Primary outcome
Patient Health Questionnaire-9 item
Time frame: Treatment Day 1 to Day 8, an average of 4 weeks.
The PHQ-9 is a 9 item self-report assessment used to evaluate symptoms of depression. Each item has a response of 0 (None at all), 1 (Several days), 2 (More than half the days), and 3 (Nearly every day). The scale ranges from 0-27, with higher scores indicating greater severity of depression symptoms.
Beck's Depression Inventory-II
Time frame: Treatment Day 1 to Day 8, an average of 4 weeks.
The BDI-II is a 21-item self-report assessment used to evaluate symptoms of depression. Each item is scored form 0-3, with a higher score representing more severe depression. The total score ranges from 0-63, with a score >29 indicating severe depression.
Generalized Anxiety Disorder-7 item
Time frame: Treatment Day 1 to Day 8, an average of 4 weeks.
The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety. Each item has a response of 0 (Not at all), 1 (Several days), 2 (More than half the days), and 3 (Nearly every day). The scale ranges from 0-21, with higher scores indicating greater severity of anxiety symptoms.
8 secondary outcomes
Antidepressant Treatment History Form: Short Form
Time frame: Baseline
Adverse childhood experiences-10 item
Time frame: Baseline
Primary care PTSD screen for DSM-5
Time frame: Baseline
Multidimensional Scale of Perceived Social Support scale
Time frame: Baseline
Subject Assessment of Memory Impairment
Time frame: Baseline
Personal Inventory for Depression and Seasonal Affective Disorder
Time frame: Baseline
Quick Inventory of Depressive Symptomatology-Self Report
Time frame: Baseline
Family history of psychiatric conditions and neurological conditions
Time frame: Baseline
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 1 Aug 2025.
- Individual participant dataSharing planned: No. Due to patient confidentiality, individual participant data will not be shared. 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Depression - Major Depressive Disorder, run by Sunnybrook Health Sciences Centre 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 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 1 Aug 2025. 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?
Patient Health Questionnaire-9 item (time frame: Treatment Day 1 to Day 8, an average of 4 weeks.). The study lists 3 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 1 Aug 2025.