Treatment Resistant DepressionPhase 2/3NCT07801703
Behavioural Activation Therapy and Ketamine for Treatment-Resistant Depression
A Phase 2/3 study testing Ketamine (0.5 mg/kg) and Behavioural Activation Therapy in people with Treatment Resistant Depression and Major Depressive Disorder (MDD), run by The Royal's Institute of Mental Health Research at 1 site in Canada.
Trial summary
The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone. We aim to find out whether participants who receive both treatments: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression, Major Depressive Disorder (MDD)
- What is being tested?
- Ketamine (0.5 mg/kg) and Behavioural Activation Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Sep 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- English speaking
- Age 18-65 at Screening
- Meeting criteria for major depressive disorder (MDD), in a major depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)
- Have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current depressive episode
- Currently in a moderate to severe depressive episode, with a minimum MADRS score of ≥22 at Screening
- Be under the care of a designated health care provider (e.g., family physician or psychiatrist) to follow their care after the completion of the study
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- Willing to maintain stable doses of concomitant psychotropic medications throughout the study
- Willing to abstain from taking prohibited medications on the days of treatment (i.e., for 12 hours prior to treatment) as per study physician instruction (e.g., benzodiazepines, cannabis)
- Able to secure a ride/chaperone home from all ketamine infusions.
Who cannot join
- Body mass index (BMI) ≥35
- Depression secondary to a stroke, cancer, or other clinically significant medical illness, per study physician judgement
- Not medically cleared to receive ketamine treatment due to presence of clinically relevant disease, per study physician judgement (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, vascular disease, diabetes mellitus, seizure disorder, intracerebral hemorrhage, history of cerebrovascular accident [CVA])
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study, as assessed during the Screening Visit medical clearance
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (<2 years) acute episode of psychosis
- Current and/or recent history (<12 months) of substance use disorder/dependence (except for alcohol, cannabis, caffeine or nicotine) as defined by DSM-5 criteria
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- Current and/or recent history (<6 months) of cannabis use disorder as defined by DSM-5 criteria, or unable to abstain from using cannabis 12 hours before and 12 hours after each ketamine infusion
- Current and/or recent history (<6 months) of alcohol use disorder as defined by DSM-5 criteria, or unable to abstain from using alcohol 12 hours before and 12 hours after each ketamine infusion
- Concurrent use of ketamine or psychedelics in any form
- A previous history or known diagnosis of major neurocognitive disorder
- Known or suspected history of intolerance, allergy or hypersensitivity to ketamine
- Any other condition or circumstance that, in the opinion of the QI/study physicians, would adversely affect the participant's ability to complete the study procedures or its measures
- Concurrent psychotherapy treatment outside the clinical trial. A participant may opt to pause or terminate their current ongoing psychotherapy to participate in the study, at their own discretion.
- Concurrent active electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Royal
Ottawa, Ontario, K1Z 7K4
Research Coordinator, 613-722-6521 ext. 6934, suwojcik@theroyal.ca
Jeanne Talbot, MD, PhD
About this study
Official title: Optimizing the Synergy Between Behavioural Activation Therapy and Intravenous Ketamine for Treatment-Resistant Depression
The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone.
We aim to find out whether participants who receive both treatments:
Read more
- Have greater reductions in depression symptoms than those who receive ketamine only
- Have better response and remission rates than those who receive ketamine only
- Experience better overall functioning, including mood, anxiety, quality of life, and physical activity than those who receive ketamine only
Participants will be randomized to one of two groups: Arm 1) concurrent ketamine and BA therapy started from treatment initiation, or Arm 2) ketamine treatment alone.
- All participants will undergo IV ketamine infusions administered twice weekly for three weeks.
- Half of the participants in will also undergo BA therapy sessions twice weekly for three weeks.
- Individuals with a sufficient treatment response after 3 weeks will proceed to undergo an additional 12 weeks of ketamine infusions (and those receiving BA therapy will continue to receive therapy for an additional 12 weeks).
Read the detailed description
This phase III study is a single-site, prospective, parallel-arm, randomized proof-of-concept clinical trial designed to estimate the preliminary effects of augmenting repeated IV ketamine treatment with concurrent BA therapy, in individuals experiencing moderate to severe treatment resistant depressive episode.
The overall goal of this work is to maximize and sustain the beneficial effects of ketamine through combined treatment with BA therapy. The central hypothesis is that patients treated concurrently with ketamine and BA will demonstrate preliminary evidence of benefit, reflected by greater improvement in depressive symptoms and participant-reported functional outcomes compared to those treated with ketamine alone.
Participants will be randomized to one of two groups: Arm 1) concurrent ketamine and BA therapy started from treatment initiation, or Arm 2) ketamine treatment alone. Both arms will undergo IV ketamine infusions administered twice weekly for three weeks (Induction Phase). Participants in Arm 1 will also undergo BA therapy sessions twice weekly for three weeks during the Induction Phase. Responders to Induction Phase treatment (defined as ≥50% reduction in MADRS total scores from Baseline to end of Induction Phase) will proceed to undergo an additional 12 weeks of ketamine infusions in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase (<50% reduction in MADRS total scores) will cease receiving ketamine infusions. Those in Arm 2 (ketamine alone) will complete their study participation at this point. Those in Arm 1 (BA+ketamine) will proceed to undergo an additional 12 weeks of BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks).
- Being tested
- Ketamine (0.5 mg/kg), Behavioural Activation Therapy
- Keywords
- Treatment Resistant Depression, Major Depressive Disorder, Ketamine, Behavioural Activation Therapy, Psychotherapy
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (0.5 mg/kg)Drug
IV ketamine will be administered under medical supervision at a fixed dose of 0.5 mg/kg infused over 40 minutes. Treatments will be administered twice weekly for three weeks during the Induction Phase (6 treatments). Participants' response to ketamine will be assessed after the Induction Phase. Those who do not meet response criteria (<50% reduction in MADRS score) will be deemed Nonresponders and will conclude receiving ketamine at that time. Those who meet the response criteria (≥50% reduction in MADRS score) will be deemed Responders and will proceed to the Maintenance Phase. During the Maintenance Phase, ketamine treatments will be administered once weekly for 8 weeks (8 treatments), followed by once biweekly for four weeks during the Discharge Preparation Phase (2 treatments). Responders will receive a total of 16 ketamine infusions over 15 weeks.
Behavioural Activation TherapyBehavioural
BA therapy is a structured, primarily talk therapy that focuses on helping people with depression increase engagement in positive, meaningful activities and reduce avoidance behaviors that reinforce low mood. The BA therapy protocol will be based on the approach described by Martell et al. (2022). Therapy sessions will be delivered virtually or in person according to participant preference. Participants in Arm 1 will receive a total of 16 BA sessions at a frequency of twice weekly for 3 weeks during the Induction Phase (6 sessions), once weekly for 8 weeks during the Maintenance Phase (8 sessions), and once biweekly for 4 weeks during the Discharge Preparation Phase (2 sessions). BA therapy sessions can occur on the same day as ketamine infusions, but not during or after the infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Ketamine + Behavioural Activation Therapy | Experimental | Participants receive IV ketamine infusions and concurrent BA therapy, both administered twice weekly for three weeks (Induction Phase). Responders to Induction Phase treatment will proceed to undergo an additional 12 weeks of ketamine infusions and BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase will cease receiving ketamine infusions and will undergo an additional 12 weeks of BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks). Receives: Drug: Ketamine (0.5 mg/kg); Behavioral: Behavioural Activation Therapy |
| Arm 2: Ketamine Only | Active comparator | Participants will undergo IV ketamine infusions administered twice weekly for three weeks (Induction Phase). Responders to Induction Phase treatment will proceed to undergo an additional 12 weeks of ketamine infusions in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase will complete their study participation at this point. Receives: Drug: Ketamine (0.5 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS from Baseline
Estimated between-group difference in change in MADRS total score from baseline (Pre-Treatment/Week 0) to the end of the Induction Phase (Post-Induction/Week 3). Additional efficacy assessment time point will include end of study (Post-Treatment/Week 15).
Measured: Week 0 to end of Week 3 and end of Week 15
Secondary outcomes (2)
Clinically Meaningful Antidepressant Outcomes
Estimated between-group differences in clinically meaningful antidepressant outcomes, including response rate (≥50% decrease in MADRS score) and remission rate (MADRS score ≤10), assessed from baseline (Pre-Treatment/Week 0) to end of Induction Phase (Post-Induction/Week 3), with additional assessment time point at the end of study (Post-Treatment/Week 15).
Measured: Week 0 to end of Week 3 and end of Week 15
Change in Perceived Functioning from Baseline
Estimated between-group differences in changes in participant-reported functional outcomes, including self-reported depression, anxiety, quality of life, anhedonia, physical activity, and functional disability, assessed from baseline (Pre-Treatment/Week 0) to end of Induction Phase (Post-Induction/Week 3), with additional assessment time point at the end of study (Post-Treatment/Week 15).
Measured: Week 0 to end of Week 3 and end of Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel-arm, randomized proof-of-concept clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal's Institute of Mental Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jeanne Talbot, The Royal's Institute of Mental Health Research
- Investigators
- Jeanne Talbot, MD, PhD, Principal investigator, The University of Ottawa Institute of Mental Health Research (IMHR) at The RoyalJennifer Phillips, PhD, Principal investigator, The University of Ottawa Institute of Mental Health Research (IMHR) at The Royal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801703
- Sponsor's protocol ID
- REB 0364
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD collected and stored within the Cardio-Neuro-Mind Data Platform (CNMDP) to which data sharing consent has been provided by the individual participant.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Synergy Between Behavioural Activation Therapy and Intravenous Ketamine for Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT07801703
- Acronym / sponsor ID
- REB 0364
- Keywords
- Treatment Resistant Depression, Major Depressive Disorder, Ketamine, Behavioural Activation Therapy, Psychotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Royal's Institute of Mental Health ResearchUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 3 Sep 2026 (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 goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone.
We aim to find out whether participants who receive both treatments:
- Have greater reductions in depression symptoms than those who receive ketamine only
- Have better response and remission rates than those who receive ketamine only
- Experience better overall functioning, including mood, anxiety, quality of life, and physical activity than those who receive ketamine only
Participants will be randomized to one of two groups: Arm 1) concurrent ketamine and BA therapy started from treatment initiation, or Arm 2) ketamine treatment alone.
- All participants will undergo IV ketamine infusions administered twice weekly for three weeks.
- Half of the participants in will also undergo BA therapy sessions twice weekly for three weeks.
- Individuals with a sufficient treatment response after 3 weeks will proceed to undergo an additional 12 weeks of ketamine infusions (and those receiving BA therapy will continue to receive therapy for an additional 12 weeks).
Detailed description
This phase III study is a single-site, prospective, parallel-arm, randomized proof-of-concept clinical trial designed to estimate the preliminary effects of augmenting repeated IV ketamine treatment with concurrent BA therapy, in individuals experiencing moderate to severe treatment resistant depressive episode.
The overall goal of this work is to maximize and sustain the beneficial effects of ketamine through combined treatment with BA therapy. The central hypothesis is that patients treated concurrently with ketamine and BA will demonstrate preliminary evidence of benefit, reflected by greater improvement in depressive symptoms and participant-reported functional outcomes compared to those treated with ketamine alone.
Participants will be randomized to one of two groups: Arm 1) concurrent ketamine and BA therapy started from treatment initiation, or Arm 2) ketamine treatment alone. Both arms will undergo IV ketamine infusions administered twice weekly for three weeks (Induction Phase). Participants in Arm 1 will also undergo BA therapy sessions twice weekly for three weeks during the Induction Phase. Responders to Induction Phase treatment (defined as ≥50% reduction in MADRS total scores from Baseline to end of Induction Phase) will proceed to undergo an additional 12 weeks of ketamine infusions in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase (<50% reduction in MADRS total scores) will cease receiving ketamine infusions. Those in Arm 2 (ketamine alone) will complete their study participation at this point. Those in Arm 1 (BA+ketamine) will proceed to undergo an additional 12 weeks of BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel-arm, randomized proof-of-concept clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Ketamine + Behavioural Activation Therapy | Experimental | Drug: Ketamine (0.5 mg/kg), Behavioral: Behavioural Activation TherapyParticipants receive IV ketamine infusions and concurrent BA therapy, both administered twice weekly for three weeks (Induction Phase). Responders to Induction Phase treatment will proceed to undergo an additional 12 weeks of ketamine infusions and BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase will cease receiving ketamine infusions and will undergo an additional 12 weeks of BA therapy in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks). |
| Arm 2: Ketamine Only | Active comparator | Drug: Ketamine (0.5 mg/kg)Participants will undergo IV ketamine infusions administered twice weekly for three weeks (Induction Phase). Responders to Induction Phase treatment will proceed to undergo an additional 12 weeks of ketamine infusions in the Maintenance and Discharge Preparation Phases (weekly for 8 weeks, then every other week for 4 weeks, respectively). Nonresponders to the Induction Phase will complete their study participation at this point. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- English speaking
- Age 18-65 at Screening
- Meeting criteria for major depressive disorder (MDD), in a major depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)
- Have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current depressive episode
- Currently in a moderate to severe depressive episode, with a minimum MADRS score of ≥22 at Screening
Key exclusion criteria (14 listed)
- Body mass index (BMI) ≥35
- Depression secondary to a stroke, cancer, or other clinically significant medical illness, per study physician judgement
- Not medically cleared to receive ketamine treatment due to presence of clinically relevant disease, per study physician judgement (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, vascular disease, diabetes mellitus, seizure disorder, intracerebral hemorrhage, history of cerebrovascular accident [CVA])
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study, as assessed during the Screening Visit medical clearance
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (<2 years) acute episode of psychosis
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 (0.5 mg/kg)IV ketamine will be administered under medical supervision at a fixed dose of 0.5 mg/kg infused over 40 minutes. Treatments will be administered twice weekly for three weeks during the Induction Phase (6 treatments). Participants' response to ketamine will be assessed after the Induction Phase. Those who do not meet response criteria (<50% reduction in MADRS score) will be deemed Nonresponders and will conclude receiving ketamine at that time. Those who meet the response criteria (≥50% reduction in MADRS score) will be deemed Responders and will proceed to the Maintenance Phase. During the Maintenance Phase, ketamine treatments will be administered once weekly for 8 weeks (8 treatments), followed by once biweekly for four weeks during the Discharge Preparation Phase (2 treatments). Responders will receive a total of 16 ketamine infusions over 15 weeks. | Drug | Arm 1: Ketamine + Behavioural Activation Therapy, Arm 2: Ketamine Only |
| Behavioural Activation TherapyBA therapy is a structured, primarily talk therapy that focuses on helping people with depression increase engagement in positive, meaningful activities and reduce avoidance behaviors that reinforce low mood. The BA therapy protocol will be based on the approach described by Martell et al. (2022). Therapy sessions will be delivered virtually or in person according to participant preference. Participants in Arm 1 will receive a total of 16 BA sessions at a frequency of twice weekly for 3 weeks during the Induction Phase (6 sessions), once weekly for 8 weeks during the Maintenance Phase (8 sessions), and once biweekly for 4 weeks during the Discharge Preparation Phase (2 sessions). BA therapy sessions can occur on the same day as ketamine infusions, but not during or after the infusion. | Behavioural | Arm 1: Ketamine + Behavioural Activation Therapy |
Primary outcome
Change in MADRS from Baseline
Time frame: Week 0 to end of Week 3 and end of Week 15
Estimated between-group difference in change in MADRS total score from baseline (Pre-Treatment/Week 0) to the end of the Induction Phase (Post-Induction/Week 3). Additional efficacy assessment time point will include end of study (Post-Treatment/Week 15).
2 secondary outcomes
Clinically Meaningful Antidepressant Outcomes
Time frame: Week 0 to end of Week 3 and end of Week 15
Change in Perceived Functioning from Baseline
Time frame: Week 0 to end of Week 3 and end of Week 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. IPD collected and stored within the Cardio-Neuro-Mind Data Platform (CNMDP) to which data sharing consent has been provided by the individual participant.
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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.
Jeanne Talbot, MD, PhD principal investigator
The University of Ottawa Institute of Mental Health Research (IMHR) at The Royal
Jennifer Phillips, PhD principal investigator
The University of Ottawa Institute of Mental Health Research (IMHR) at The Royal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine (0.5 mg/kg) and Behavioural Activation Therapy in people with Treatment Resistant Depression and Major Depressive Disorder (MDD), run by The Royal's Institute of Mental Health Research 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (613-722-6521 ext. 6934, suwojcik@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MADRS from Baseline (time frame: Week 0 to end of Week 3 and end of Week 15). 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 3 Sep 2026.