DepressionPhase 4NCT02924090
Hyperventilation Combined With Etomidate or Ketamine Anesthesia in ECT Treatment of Major Depression
A Phase 4 study testing Etomidate, Ketamine and Hyperventilation in people with Depression, run by University of Manitoba at 1 site in Canada.
Trial summary
This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients with Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Etomidate, Ketamine and Hyperventilation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Dec 2018
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients aged 18 to 85 years
- Diagnosed with Major Depressive Disorder, unipolar or bipolar depression
- Undergoing ECT for treatment of their symptoms
- Currently residing in Manitoba
Who cannot join
- Relative contraindications to ECT therapy (recent MI or CVA, increased intracranial pressure, intracranial mass lesion, intracranial aneurysm, epilepsy, known cardiac arrhythmia, pheochromocytoma, pregnancy)
- Contraindications to etomidate (sepsis, primary or secondary adrenal insufficiency, porphyria)
- DSM-V diagnosis of a lifetime history of psychotic spectrum disorder
- Drug or alcohol dependence, or abuse within the past 3 months, soy-bean oil allergy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Ian McIntyre, MD, MSc, 204 787-2560, ian.mcintyre@umanitoba.ca
About this study
Official title: Hyperventilation and ECT Seizure Duration: Effects on Cerebral Oxygen Saturation, and Therapeutic Outcome With Comparisons Between Etomidate and Ketamine in Patients With Major Depressive Disorder
This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients with Major Depressive Disorder. Comparison of etomidate and ketamine on remission of depressive symptoms with and without pre-emptive hyperventilation will also be studied.
Read the detailed description
Electroconvulsive therapy (ECT) is an effective treatment for medication-resistant forms of depression, including major depressive disorder and mania. Therapeutic success of ECT is related to the duration and quality of Electroencephalogram (EEG) and motor seizures. Previous studies have demonstrated that deliberate hyperventilation augments seizure duration in anesthetized subjects. It has also been shown that seizure activity significantly increases cerebral metabolic rate, predisposing the patient to potentially severe cerebral desaturation events. These desaturation events are predicted to be exacerbated by pre-emptive hyperventilation which has a potent cerebral vasoconstrictive effect. Despite the widespread use of ECT, little is known about the effect of hyperventilation on cerebral metabolism in this setting. Ketamine has recently been demonstrated to have anti-depressant properties in patients with major depressive disorder, suggesting that patients treated with ketamine anesthesia and then ECT, may benefit clinically from the additive effects of both treatment modalities, compared to ECT alone.
The investigators hypothesize that hyperventilation will facilitate prolonged seizure duration and faster remission of depressive symptoms. As well there may be significant cerebral desaturation and cardiovascular side effects of ECT therapy following hyperventilation. Lastly, the effect of hyperventilation on the efficacy of ECT therapy may be improved when ketamine anesthesia is used simultaneously. To test this hypothesis this study will compare ketamine anesthesia to etomidate anesthesia. Etomidate is a short acting anesthetic that is commonly used in these procedures.
The study objectives (primary and secondary) are as follows:
- To quantify the effect of hyperventilation and type of anesthetic agent on ECT-induced seizure duration
- To assess the effect of hyperventilation immediately prior to ECT on cerebral metabolism as measured by cerebral oximetry
- To determine the effect of hyperventilation and anesthetic agent on the remission of symptoms in Major Depressive Disorder
- To assess the side effect profile of hyperventilation during ECT on hemodynamics
- Conditions
- Depression
- Being tested
- Etomidate, Ketamine, Hyperventilation, Electroconvulsive therapy (ECT)
- Keywords
- Major depressive disorder, Etomidate, Ketamine, Hyperventilation, Electroconvulsive therapy, Depression, Anesthesia, Nervous System Diseases, Mental Disorders, Electroencephalography, Cerebral Metabolism
- Medical subject headings
- Depression, Depressive Disorder, Major, Hyperventilation, Nervous System Diseases, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Also called Amidate
Etomidate will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.3 mg/kg
KetamineDrug
Also called Ketalar
Ketamine will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.5 to 1.0 mg/kg.
HyperventilationProcedure or surgery
Hyperventilation will be performed in patients after full pre-oxygenation and induction of anesthesia, by administering 20 breaths in 30 seconds using a well-fitting face mask immediately before application of the ECT electrical stimulus.
Electroconvulsive therapy (ECT)Procedure or surgery
Bilateral, bitemporal electrode placement will be utilized to elicit a seizure via a SpECTrun 5000Q (MECTA Inc.). The electrical dose required will be determined in advance by the patient's attending psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| ECT with Etomidate | Active comparator | Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Receives: Drug: Etomidate; Procedure: Electroconvulsive therapy (ECT) |
| ECT with Ketamine | Active comparator | Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Receives: Drug: Ketamine; Procedure: Electroconvulsive therapy (ECT) |
| ECT with Etomidate and Hyperventilation | Active comparator | Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT. Receives: Drug: Etomidate; Procedure: Hyperventilation; Procedure: Electroconvulsive therapy (ECT) |
| ECT with Ketamine and Hyperventilation | Active comparator | Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT. Receives: Drug: Ketamine; Procedure: Hyperventilation; Procedure: Electroconvulsive therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG seizure duration (seconds)
Duration of seizure spike wave morphology will be assessed by the attending psychiatrist and independently by a second psychiatrist.
Measured: Up to 3 minutes post ECT
ECT-induced seizure duration (seconds)
Duration of motor seizures will be assessed by timing the onset and offset of appropriate motor twitches in the intrinsic foot muscles and extra-ocular muscles by the attending psychiatrist.
Measured: Up to 3 minutes post ECT
Secondary outcomes (8)
Changes in cerebral metabolism assessed by cerebral saturation (%)
Cerebral metabolism will be assessed by continuous cerebral oximetry measurements using the ForeSight Cerebral Oximeter, from immediately prior to ECT to 5 minutes post ECT
Measured: Up to 5 minutes post ECT
Remission of depressive symptoms assessed by HAM-D
Patients will be assessed using a clinician-administered Hamilton Depression Rating Scale (HAM-D) both prior to, and at intervals of 2, 4 and 8 weeks after completion of the study. The HAM-D is a validated healthcare professional-administered assessments of clinical depressive symptoms including: hopelessness, guilt or depressed mood and physical symptoms such as agitation, restlessness and fatigue.
Measured: Approximately one week prior to, and at 2, 4 and 8 weeks post ECT
Remission of depressive symptoms assessed by MADRS
Patients will be assessed using a clinician-administered Montgomery-Asberg Depression Scale (MADRS) both prior to, and at intervals of 2, 4 and 8 weeks after completion of the study. The MADRS is a validated healthcare professional-administered assessments of clinical depressive symptoms including: hopelessness, guilt or depressed mood and physical symptoms such as agitation, restlessness and fatigue.
Measured: Approximately one week prior to, and at 2, 4 and 8 weeks post ECT
Effect on blood pressure
Systolic, diastolic and mean blood pressure will be recorded every minute from immediately prior to 7 minutes post ECT.
Measured: Up to 7 minutes post ECT
Effect on heart rate
Heart rate (bpm) will be continuously recorded from immediately prior to 7 minutes post ECT.
Measured: Up to 7 minutes post ECT
Duration of stay in post-anesthesia care unit (hours)
Measured: Up to 2 hours post arrival in post-anesthesia care unit (PACU).
Incidence of nausea in post-anesthesia care unit (%)
The number of instances of nausea while in PACU will be recorded.
Measured: Up to 2 hours post arrival in PACU.
Incidence of vomiting in post-anesthesia care unit (%)
The number of instances of vomiting while in PACU will be recorded.
Measured: Up to 2 hours post arrival in PACU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian McIntyre, MD, MSc, Principal investigator, University of ManitobaMichael Harrington, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924090
- Sponsor's protocol ID
- B2015050
- Status last verified
- Sep 2016
- First submitted
- 30 Sep 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Loo C, Simpson B, MacPherson R. Augmentation strategies in electroconvulsive therapy. J ECT. 2010 Sep;26(3):202-7. doi: 10.1097/YCT.0b013e3181e48143.
PubMed 20562640Aksay SS, Bumb JM, Janke C, Hoyer C, Kranaster L, Sartorius A. New evidence for seizure quality improvement by hyperoxia and mild hypocapnia. J ECT. 2014 Dec;30(4):287-91. doi: 10.1097/YCT.0000000000000109.
PubMed 24625713Fabbri F, Henry ME, Renshaw PF, Nadgir S, Ehrenberg BL, Franceschini MA, Fantini S. Bilateral near-infrared monitoring of the cerebral concentration and oxygen-saturation of hemoglobin during right unilateral electro-convulsive therapy. Brain Res. 2003 Dec 5;992(2):193-204. doi: 10.1016/j.brainres.2003.08.034.
PubMed 14625058Ghasemi M, Kazemi MH, Yoosefi A, Ghasemi A, Paragomi P, Amini H, Afzali MH. Rapid antidepressant effects of repeated doses of ketamine compared with electroconvulsive therapy in hospitalized patients with major depressive disorder. Psychiatry Res. 2014 Feb 28;215(2):355-61. doi: 10.1016/j.psychres.2013.12.008. Epub 2013 Dec 13.
PubMed 24374115
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperventilation and ECT Seizure Duration: Effects on Cerebral Oxygen Saturation, and Therapeutic Outcome With Comparisons Between Etomidate and Ketamine in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02924090
- Acronym / sponsor ID
- B2015050
- Conditions
- Depression
- Keywords
- Major depressive disorder, Etomidate, Ketamine, Hyperventilation, Electroconvulsive therapy, Depression, Anesthesia, Nervous System Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- 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.
This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients with Major Depressive Disorder. Comparison of etomidate and ketamine on remission of depressive symptoms with and without pre-emptive hyperventilation will also be studied.
Detailed description
Electroconvulsive therapy (ECT) is an effective treatment for medication-resistant forms of depression, including major depressive disorder and mania. Therapeutic success of ECT is related to the duration and quality of Electroencephalogram (EEG) and motor seizures. Previous studies have demonstrated that deliberate hyperventilation augments seizure duration in anesthetized subjects. It has also been shown that seizure activity significantly increases cerebral metabolic rate, predisposing the patient to potentially severe cerebral desaturation events. These desaturation events are predicted to be exacerbated by pre-emptive hyperventilation which has a potent cerebral vasoconstrictive effect. Despite the widespread use of ECT, little is known about the effect of hyperventilation on cerebral metabolism in this setting. Ketamine has recently been demonstrated to have anti-depressant properties in patients with major depressive disorder, suggesting that patients treated with ketamine anesthesia and then ECT, may benefit clinically from the additive effects of both treatment modalities, compared to ECT alone.
The investigators hypothesize that hyperventilation will facilitate prolonged seizure duration and faster remission of depressive symptoms. As well there may be significant cerebral desaturation and cardiovascular side effects of ECT therapy following hyperventilation. Lastly, the effect of hyperventilation on the efficacy of ECT therapy may be improved when ketamine anesthesia is used simultaneously. To test this hypothesis this study will compare ketamine anesthesia to etomidate anesthesia. Etomidate is a short acting anesthetic that is commonly used in these procedures.
The study objectives (primary and secondary) are as follows:
- To quantify the effect of hyperventilation and type of anesthetic agent on ECT-induced seizure duration
- To assess the effect of hyperventilation immediately prior to ECT on cerebral metabolism as measured by cerebral oximetry
- To determine the effect of hyperventilation and anesthetic agent on the remission of symptoms in Major Depressive Disorder
- To assess the side effect profile of hyperventilation during ECT on hemodynamics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ECT with Etomidate | Active comparator | Drug: Etomidate, Procedure: Electroconvulsive therapy (ECT)Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. |
| ECT with Ketamine | Active comparator | Drug: Ketamine, Procedure: Electroconvulsive therapy (ECT)Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. |
| ECT with Etomidate and Hyperventilation | Active comparator | Drug: Etomidate, Procedure: Hyperventilation, Procedure: Electroconvulsive therapy (ECT)Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT. |
| ECT with Ketamine and Hyperventilation | Active comparator | Drug: Ketamine, Procedure: Hyperventilation, Procedure: Electroconvulsive therapy (ECT)Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults patients aged 18 to 85 years
- Diagnosed with Major Depressive Disorder, unipolar or bipolar depression
- Undergoing ECT for treatment of their symptoms
- Currently residing in Manitoba
Key exclusion criteria (4 listed)
- Relative contraindications to ECT therapy (recent MI or CVA, increased intracranial pressure, intracranial mass lesion, intracranial aneurysm, epilepsy, known cardiac arrhythmia, pheochromocytoma, pregnancy)
- Contraindications to etomidate (sepsis, primary or secondary adrenal insufficiency, porphyria)
- DSM-V diagnosis of a lifetime history of psychotic spectrum disorder
- Drug or alcohol dependence, or abuse within the past 3 months, soy-bean oil allergy
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 |
|---|---|---|
| EtomidateAlso: AmidateEtomidate will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.3 mg/kg | Drug | ECT with Etomidate, ECT with Etomidate and Hyperventilation |
| KetamineAlso: KetalarKetamine will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.5 to 1.0 mg/kg. | Drug | ECT with Ketamine, ECT with Ketamine and Hyperventilation |
| HyperventilationHyperventilation will be performed in patients after full pre-oxygenation and induction of anesthesia, by administering 20 breaths in 30 seconds using a well-fitting face mask immediately before application of the ECT electrical stimulus. | Procedure or surgery | ECT with Etomidate and Hyperventilation, ECT with Ketamine and Hyperventilation |
| Electroconvulsive therapy (ECT)Bilateral, bitemporal electrode placement will be utilized to elicit a seizure via a SpECTrun 5000Q (MECTA Inc.). The electrical dose required will be determined in advance by the patient's attending psychiatrist. | Procedure or surgery | ECT with Etomidate, ECT with Etomidate and Hyperventilation, ECT with Ketamine, ECT with Ketamine and Hyperventilation |
Primary outcome
EEG seizure duration (seconds)
Time frame: Up to 3 minutes post ECT
Duration of seizure spike wave morphology will be assessed by the attending psychiatrist and independently by a second psychiatrist.
ECT-induced seizure duration (seconds)
Time frame: Up to 3 minutes post ECT
Duration of motor seizures will be assessed by timing the onset and offset of appropriate motor twitches in the intrinsic foot muscles and extra-ocular muscles by the attending psychiatrist.
8 secondary outcomes
Changes in cerebral metabolism assessed by cerebral saturation (%)
Time frame: Up to 5 minutes post ECT
Remission of depressive symptoms assessed by HAM-D
Time frame: Approximately one week prior to, and at 2, 4 and 8 weeks post ECT
Remission of depressive symptoms assessed by MADRS
Time frame: Approximately one week prior to, and at 2, 4 and 8 weeks post ECT
Effect on blood pressure
Time frame: Up to 7 minutes post ECT
Effect on heart rate
Time frame: Up to 7 minutes post ECT
Duration of stay in post-anesthesia care unit (hours)
Time frame: Up to 2 hours post arrival in post-anesthesia care unit (PACU).
Incidence of nausea in post-anesthesia care unit (%)
Time frame: Up to 2 hours post arrival in PACU.
Incidence of vomiting in post-anesthesia care unit (%)
Time frame: Up to 2 hours post arrival in PACU.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Background: PubMed 20562640Loo C, Simpson B, MacPherson R. Augmentation strategies in electroconvulsive therapy. J ECT. 2010 Sep;26(3):202-7. doi: 10.1097/YCT.0b013e3181e48143.
- Background: PubMed 24625713Aksay SS, Bumb JM, Janke C, Hoyer C, Kranaster L, Sartorius A. New evidence for seizure quality improvement by hyperoxia and mild hypocapnia. J ECT. 2014 Dec;30(4):287-91. doi: 10.1097/YCT.0000000000000109.
- Background: PubMed 14625058Fabbri F, Henry ME, Renshaw PF, Nadgir S, Ehrenberg BL, Franceschini MA, Fantini S. Bilateral near-infrared monitoring of the cerebral concentration and oxygen-saturation of hemoglobin during right unilateral electro-convulsive therapy. Brain Res. 2003 Dec 5;992(2):193-204. doi: 10.1016/j.brainres.2003.08.034.
- Background: PubMed 24374115Ghasemi M, Kazemi MH, Yoosefi A, Ghasemi A, Paragomi P, Amini H, Afzali MH. Rapid antidepressant effects of repeated doses of ketamine compared with electroconvulsive therapy in hospitalized patients with major depressive disorder. Psychiatry Res. 2014 Feb 28;215(2):355-61. doi: 10.1016/j.psychres.2013.12.008. Epub 2013 Dec 13.
- 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.
Ian McIntyre, MD, MSc principal investigator
University of Manitoba
Michael Harrington, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etomidate, Ketamine and Hyperventilation in people with Depression, run by University of Manitoba 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 4 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 21 Oct 2016. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Ian McIntyre, MD, MSc (204 787-1414, ian.mcintyre@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG seizure duration (seconds) (time frame: Up to 3 minutes post ECT). The study lists 2 primary outcomes in all. 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 NCT02924090, which also lists 4 linked publications.
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 21 Oct 2016.