Treatment Resistant DepressionNCT01555021
Pharmacogenomics for Antidepressant Guidance and Education
An observational study of Treatment Resistant Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
More than one out of three individuals treated for major depressive disorder (MDD) do not experience a full reduction of symptoms even when treated with adequate antidepressant medication. These individuals may have treatment-resistant depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Genotyping assays
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study was conducted on the 24-bed inpatient psychiatric unit at Massachusetts General Hospital. Written informed consent was obtained using the MGH-IRB approved consent form. A competency assessment consisting of four questions about the study was obtained. All subjects received a comprehensive psychiatric and medical evaluation including a comprehensive metabolic panel, TSH B12, folic acid, lipid panel and a urine pregnancy test for women of child-bearing age. Subjects needed to meet DSM-IV criteria for major depressive disorder.
Who may be able to join
- Age 18-70
- Written informed consent
- Meets DSM-IV criteria in the Structured Clinical Interview for DSM-IV-TR (SCID-I/P)17 and the MINI for current major depressive disorder, without psychotic features
- QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
- Failure of at least 1 prior adequate trial of a standard antidepressant (i.e., 6 weeks at adequate dose), assessed by the Antidepressant Treatment History Questionnaire (ATRQ)18 criteria
- Inpatient and expected to remain so for 5 or more days
- Hospitalized within past 72 hours
Who cannot join
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy). Immediately after the pregnancy test, women with positive pregnancy tests will be unable to enroll in the study
- Women who are breastfeeding
- Patients who have taken an investigational psychotropic drug within the last 3 months
- Section 12 status (involuntary admission)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
More than one out of three individuals treated for major depressive disorder (MDD) do not experience a full reduction of symptoms even when treated with adequate antidepressant medication. These individuals may have treatment-resistant depression. This is a condition that contributes to the tremendous costs of MDD, in terms of health care costs, functional impairment (limitation of an individual's functional ability), and diminished quality of life.
There is a clear need for personalized medicine, for people at high risk for treatment-resistant depression. If these individuals could be identified early in the course of their depression, they could be recommended for more intensive or specialized interventions. Doing so could improve their likelihood of having a full reduction in their symptoms.
Read more
Today, there are many treatment options for MDD. Individuals can spend months or years in and out of treatment before receiving one that works for their treatment-resistant depression.
The investigators want to study treatment resistant depression by examining specific genes (genotyping) that might influence how your body responds to certain antidepressant medications. This process of examining specific genes is not experimental. To look at your specific genes, the investigators will collect a blood sample. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Genes are contained in your DNA (deoxyribonucleic acid). There are many differences in DNA, from one person to another. These differences may affect a person's chances of having a particular disease.
Read the detailed description
This will be a 6-month, randomized, controlled study of assay-guided treatment (AGT) versus treatment as usual (TAU) in adult inpatients with major depressive disorder. Two hundred subjects will be randomized to receive AGT or TAU. After subjects are screened, determined to be eligible, and complete baseline assessments, blood samples for genotyping will be obtained from all subjects as well as saliva samples for future GWAS analysis from all subjects. Only those subjects that are randomized to the AGT arm will have their blood samples immediately analyzed. Subjects in the TAU arm will have their blood samples stored for future analysis..
Once the blood samples are obtained, the attending psychiatrists will be asked to indicate their top three choices of antidepressants and at what doses they will initiate treatment. In order to prevent delays in providing treatments, the first choice antidepressants will be started prior to receiving assay results.
Upon receiving the assay reports (AGT arm), the attending psychiatrists will be asked whether the reports influenced their choice of antidepressant treatments and doses of antidepressants, as well as their confidence in their choices. The attending psychiatrists will then document any switches in antidepressant treatments or changes in doses of current antidepressant medications on a structured form. The assay reports will be available between 3 to 5 days after the blood samples are taken. The attending psychiatrists who are randomized to be provided the results of CYP genotyping will also be provided a phone number for consultation with Genomind Labs regarding the interpretation of the results.
Trough antidepressant blood samples for the AGT arm (10-12 hours after last dose) for therapeutic drug monitoring (TDM) will be obtained within 24 hours of discharge. Blood samples will also be obtained from the TAU arm, but they will be stored for future analysis of CYP genotyping and biomarker analysis of treatment resistant MDD. Clinical follow-up will proceed as felt to be clinically indicated. For subjects who have been discharged before the assay results are received, the attending psychiatrists will complete the from indicating changes in treatments as if patients were still in hospital. Results and recommendations will be forwarded to the identified outpatient psychiatrists. (note: blood levels of antidepressants were not analyzed)
The AGT arm is not standard care for patients with depression. The addition of assay-results and questionnaires makes the AGT arm different than standard care. Only the questionnaires make the TAU arm different than standard care.
Note:
Within 24 hours after you are admitted to the Inpatient Psychiatric Unit, the "baseline" assessment will occur. If you stay in the Inpatient Psychiatric Unit for more than one week, the "weekly" assessment will occur every 7 days. Typically, patients spend an average of 8-10 days in the Inpatient Psychiatric Unit. The day before or the day of your discharge from the Inpatient Psychiatric Unit, your "discharge" assessment will occur. One, 3, and 6 months after you are discharged, you will be asked to complete follow-up assessments.
- Conditions
- Treatment Resistant Depression
- Being tested
- Genotyping assays
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotyping assaysGenetic
Patients will provide blood samples at the beginning of the study. If the patient is in the AGT group (as opposed to the TAU group), their blood samples will be sent for genotyping immediately. AGT psychiatrists will be given the results of genotyping within 3-5 days in order to decide which antidepressants to use long-term and at what doses. Patients in the Treatment as Usual group will have their blood samples stored for future analysis. Both groups will provide saliva samples for GWAS analysis at a alter date; however, since the study was terminated early, GWAS testing for both groups and genotyping for the TAU group were not performed.
Patients will receive questionnaires to measure their mood, side effects, and symptoms.
Patients will be asked to participate in 3 follow-up phone calls (1 month, 3 months, and 6 months) to measure their mood.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | This group will provide blood samples to be analyzed at a later date for genotyping to determine the activity of CYP-450 enzymes that are important in metabolizing antidepressant medications.Treatment will be initiated based on the attending clinicians decision making absent genotyping results. All subjects in the group will receive the following assessment instruments for diagnosis: SCID-I/P and the Mini International Neuropsychiatric Interview (MINI) All subjects in the group will have the severity of their depression measured by the HAM D-17 (physician rating scale), the QIDS-SR-16 (patient rating). Clinical status will be measured by the CGI-S scale (1-7 with 7 being high functioning). Side effects ratings will be measured by the UKU. ATRQ will be used to assess the degree of treatment resistance by measuring the number of prior antidepressant trials. Patients in the TAU group will provide saliva samples for future GWAS analysis. | |
| Assay Guided Treatment (AGT) | This group will provide blood samples for genotyping test to determine the activity of CYP-450 enzymes that are important in metabolizing antidepressant medications . This test result will be available within 3-5 days available to guide clinicians in their choice and dosing of antidepressant medications.
All subjects in the group will have the severity of their depression measured by the Hamilton Depression Rating Scale-17 (physician rating scale), the QIDS-SR-16 (patient rating scale). Clinical status will be measured by the CGI-S scale (1-7 with 7 being high functioning). Side effects ratings will be measured by the Udvalg for Kliniske Undersogelser (UKU). ATRQ will be used to assess the degree of treatment resistance by measuring the number of prior antidepressant trials.
Patients in the AGT group will provide saliva samples for future GWAS analysis. Receives: Genetic: Genotyping assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quick Inventory of Depressive Symptoms-Self Rating (SR) 16 Item
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in the Quick Inventory of Depressive Symptoms (QIDS-SR 16), adjusted for baseline severity, upon discharge, and at 1, 3, and 6 months post discharge from inpatient treatment. The QUIDS-SR 16 is a self rating 16 item multiple-choice questionnaire that measure severity of depression over the past week. The range on the QIDS-SR IS 0-27, with 0-5 indicating no depression; 6-10, mild depression; 11-15; moderate depression; 16-20 severe depression; and greater than or equal to 21, very severe depression.
Measured: Measured: Baseline (within 72 hours of admission), once weekly (+/- 24 hours), discharge (7-10 days after admission +/- 24 hours), and 1, 3, 6 months after discharge (+/- 4 weeks)
Secondary outcomes (3)
Clinician's Report That AGT Modified His/Her Decision Regarding Which Antidepressant to Prescribe.
Clinicians randomized to receive AGT results were asked to report whether the AGT results impacted their decision making with regards to their choice of antidepressant and/or dosing of the antidepressant.
Measured: Measured: +/- 24 hours of baseline assessments and +/- 24 hours of receiving assay results
Treatment Adherence
To determine the impact on adherence of AGT versus TAU at 7-10 days after admission
Measured: To determine the impact on adherence of AGT versus TAU at 7-10 days after admission
Adverse Events (Side Effects)
To determine the impact of AGT versus TAU on total number of side effects determined by using the Udvalg for Kliniske Undersogelser (UKU).
- TAU group reported a total of 8 different side effects, but 11 total events with two subjects over the time frame listed below; the events were expected. (see itemized adverse events)
- AGT group reported a total of four different side effects and 4 events with one subject over the time frame listed; the events were expected.(see itemized adverse events)
Measured: Measures at discharge, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: The study was an inpatient, but PI left inpatient at MGH on July 1, 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John D. Matthews, Massachusetts General Hospital
- Investigators
- John D Matthews, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555021
- Sponsor's protocol ID
- 2011-P-001921
- Status last verified
- Mar 2018
- First submitted
- 16 Feb 2012
- Last updated
- 5 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics for Antidepressant Guidance and Education
- ClinicalTrials.gov ID
- NCT01555021
- Acronym / sponsor ID
- 2011-P-001921
- Conditions
- Treatment Resistant Depression
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was an inpatient, but PI left inpatient at MGH on July 1, 2012
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than one out of three individuals treated for major depressive disorder (MDD) do not experience a full reduction of symptoms even when treated with adequate antidepressant medication. These individuals may have treatment-resistant depression. This is a condition that contributes to the tremendous costs of MDD, in terms of health care costs, functional impairment (limitation of an individual's functional ability), and diminished quality of life.
There is a clear need for personalized medicine, for people at high risk for treatment-resistant depression. If these individuals could be identified early in the course of their depression, they could be recommended for more intensive or specialized interventions. Doing so could improve their likelihood of having a full reduction in their symptoms.
Today, there are many treatment options for MDD. Individuals can spend months or years in and out of treatment before receiving one that works for their treatment-resistant depression.
The investigators want to study treatment resistant depression by examining specific genes (genotyping) that might influence how your body responds to certain antidepressant medications. This process of examining specific genes is not experimental. To look at your specific genes, the investigators will collect a blood sample. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Genes are contained in your DNA (deoxyribonucleic acid). There are many differences in DNA, from one person to another. These differences may affect a person's chances of having a particular disease.
Detailed description
This will be a 6-month, randomized, controlled study of assay-guided treatment (AGT) versus treatment as usual (TAU) in adult inpatients with major depressive disorder. Two hundred subjects will be randomized to receive AGT or TAU. After subjects are screened, determined to be eligible, and complete baseline assessments, blood samples for genotyping will be obtained from all subjects as well as saliva samples for future GWAS analysis from all subjects. Only those subjects that are randomized to the AGT arm will have their blood samples immediately analyzed. Subjects in the TAU arm will have their blood samples stored for future analysis..
Once the blood samples are obtained, the attending psychiatrists will be asked to indicate their top three choices of antidepressants and at what doses they will initiate treatment. In order to prevent delays in providing treatments, the first choice antidepressants will be started prior to receiving assay results.
Upon receiving the assay reports (AGT arm), the attending psychiatrists will be asked whether the reports influenced their choice of antidepressant treatments and doses of antidepressants, as well as their confidence in their choices. The attending psychiatrists will then document any switches in antidepressant treatments or changes in doses of current antidepressant medications on a structured form. The assay reports will be available between 3 to 5 days after the blood samples are taken. The attending psychiatrists who are randomized to be provided the results of CYP genotyping will also be provided a phone number for consultation with Genomind Labs regarding the interpretation of the results.
Trough antidepressant blood samples for the AGT arm (10-12 hours after last dose) for therapeutic drug monitoring (TDM) will be obtained within 24 hours of discharge. Blood samples will also be obtained from the TAU arm, but they will be stored for future analysis of CYP genotyping and biomarker analysis of treatment resistant MDD. Clinical follow-up will proceed as felt to be clinically indicated. For subjects who have been discharged before the assay results are received, the attending psychiatrists will complete the from indicating changes in treatments as if patients were still in hospital. Results and recommendations will be forwarded to the identified outpatient psychiatrists. (note: blood levels of antidepressants were not analyzed)
The AGT arm is not standard care for patients with depression. The addition of assay-results and questionnaires makes the AGT arm different than standard care. Only the questionnaires make the TAU arm different than standard care.
Note:
Within 24 hours after you are admitted to the Inpatient Psychiatric Unit, the "baseline" assessment will occur. If you stay in the Inpatient Psychiatric Unit for more than one week, the "weekly" assessment will occur every 7 days. Typically, patients spend an average of 8-10 days in the Inpatient Psychiatric Unit. The day before or the day of your discharge from the Inpatient Psychiatric Unit, your "discharge" assessment will occur. One, 3, and 6 months after you are discharged, you will be asked to complete follow-up assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | – | –This group will provide blood samples to be analyzed at a later date for genotyping to determine the activity of CYP-450 enzymes that are important in metabolizing antidepressant medications.Treatment will be initiated based on the attending clinicians decision making absent genotyping results. All subjects in the group will receive the following assessment instruments for diagnosis: SCID-I/P and the Mini International Neuropsychiatric Interview (MINI) All subjects in the group will have the severity of their depression measured by the HAM D-17 (physician rating scale), the QIDS-SR-16 (patient rating). Clinical status will be measured by the CGI-S scale (1-7 with 7 being high functioning). Side effects ratings will be measured by the UKU. ATRQ will be used to assess the degree of treatment resistance by measuring the number of prior antidepressant trials. Patients in the TAU group will provide saliva samples for future GWAS analysis. |
| Assay Guided Treatment (AGT) | – | Genetic: Genotyping assaysThis group will provide blood samples for genotyping test to determine the activity of CYP-450 enzymes that are important in metabolizing antidepressant medications . This test result will be available within 3-5 days available to guide clinicians in their choice and dosing of antidepressant medications. All subjects in the group will have the severity of their depression measured by the Hamilton Depression Rating Scale-17 (physician rating scale), the QIDS-SR-16 (patient rating scale). Clinical status will be measured by the CGI-S scale (1-7 with 7 being high functioning). Side effects ratings will be measured by the Udvalg for Kliniske Undersogelser (UKU). ATRQ will be used to assess the degree of treatment resistance by measuring the number of prior antidepressant trials. Patients in the AGT group will provide saliva samples for future GWAS analysis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted on the 24-bed inpatient psychiatric unit at Massachusetts General Hospital. Written informed consent was obtained using the MGH-IRB approved consent form. A competency assessment consisting of four questions about the study was obtained. All subjects received a comprehensive psychiatric and medical evaluation including a comprehensive metabolic panel, TSH B12, folic acid, lipid panel and a urine pregnancy test for women of child-bearing age. Subjects needed to meet DSM-IV criteria for major depressive disorder.
Key inclusion criteria (7 listed)
- Age 18-70
- Written informed consent
- Meets DSM-IV criteria in the Structured Clinical Interview for DSM-IV-TR (SCID-I/P)17 and the MINI for current major depressive disorder, without psychotic features
- QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
- Failure of at least 1 prior adequate trial of a standard antidepressant (i.e., 6 weeks at adequate dose), assessed by the Antidepressant Treatment History Questionnaire (ATRQ)18 criteria
Key exclusion criteria (4 listed)
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy). Immediately after the pregnancy test, women with positive pregnancy tests will be unable to enroll in the study
- Women who are breastfeeding
- Patients who have taken an investigational psychotropic drug within the last 3 months
- Section 12 status (involuntary admission)
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 |
|---|---|---|
| Genotyping assaysPatients will provide blood samples at the beginning of the study. If the patient is in the AGT group (as opposed to the TAU group), their blood samples will be sent for genotyping immediately. AGT psychiatrists will be given the results of genotyping within 3-5 days in order to decide which antidepressants to use long-term and at what doses. Patients in the Treatment as Usual group will have their blood samples stored for future analysis. Both groups will provide saliva samples for GWAS analysis at a alter date; however, since the study was terminated early, GWAS testing for both groups and genotyping for the TAU group were not performed. Patients will receive questionnaires to measure their mood, side effects, and symptoms. Patients will be asked to participate in 3 follow-up phone calls (1 month, 3 months, and 6 months) to measure their mood. | Genetic | Assay Guided Treatment (AGT) |
Primary outcome
Change in Quick Inventory of Depressive Symptoms-Self Rating (SR) 16 Item
Time frame: Measured: Baseline (within 72 hours of admission), once weekly (+/- 24 hours), discharge (7-10 days after admission +/- 24 hours), and 1, 3, 6 months after discharge (+/- 4 weeks)
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in the Quick Inventory of Depressive Symptoms (QIDS-SR 16), adjusted for baseline severity, upon discharge, and at 1, 3, and 6 months post discharge from inpatient treatment. The QUIDS-SR 16 is a self rating 16 item multiple-choice questionnaire that measure severity of depression over the past week. The range on the QIDS-SR IS 0-27, with 0-5 indicating no depression; 6-10, mild depression; 11-15; moderate depression; 16-20 severe depression; and greater than or equal to 21, very severe depression.
3 secondary outcomes
Clinician's Report That AGT Modified His/Her Decision Regarding Which Antidepressant to Prescribe.
Time frame: Measured: +/- 24 hours of baseline assessments and +/- 24 hours of receiving assay results
Treatment Adherence
Time frame: To determine the impact on adherence of AGT versus TAU at 7-10 days after admission
Adverse Events (Side Effects)
Time frame: Measures at discharge, 1 month, 3 months, and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John D Matthews, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Resistant Depression, run by Massachusetts General Hospital at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 5 Nov 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Quick Inventory of Depressive Symptoms-Self Rating (SR) 16 Item (time frame: Measured: Baseline (within 72 hours of admission), once weekly (+/- 24 hours), discharge (7-10 days after admission +/- 24 hours), and 1, 3, 6 months after discharge (+/- 4 weeks)). 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 5 Nov 2018.