DepressionPhase 1NCT02800577
Using Computer Tasks to Predict Response to Antidepressants
A Phase 1 study testing General Practitioner Emotional Test Battery (GP-ETB) in people with Depression, run by P1vital Products Limited at 10 sites in United Kingdom.
Trial summary
In England over 800,000 patients each year are either newly diagnosed with depression or present with a new episode of depression in primary care. The majority of patients do not respond to the first drug prescribed and have to try several different antidepressants before an effective treatment is found. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- General Practitioner Emotional Test Battery (GP-ETB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Jun 2014to Mar 2015
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female and aged between 18 and 65 inclusive.
- Diagnosed by GP with a depressive episode requiring treatment with citalopram (new or recurrent diagnosis).
- Prescribed citalopram by GP for treatment of depression within past 3 days but has not yet started taking medication.
- Is intending to start citalopram treatment within 2 days of Visit 1.
- Fluent English speaker.
- Has not consumed more than 4 units of alcohol in the 24 hours prior to Visit 1 and has not consumed any alcohol in the 8 hours prior to Visit 1.
Show all 11Show fewer
- Has not smoked tobacco in the 2 hours prior to completing the GP-ETB at Visit 1.
- Has not consumed any beverages containing caffeine for 2 hours prior to completing the GPETB at Visit 1.
- Has not consumed any psychoactive substances for 24 hours prior to Visit 1.
- Willing and able to comply with study procedures, including treatment with citalopram and study prohibitions and restrictions.
- Patient must have signed the informed consent form prior to the first study related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
Who cannot join
- Pregnant or breastfeeding, or planning to become pregnant during study, as determined through interview with patient.
- Currently taking antidepressant medication.
- Has taken antidepressant medication in the past 3 months.
- Currently taking anti-psychotic or regular sedative medication, or is likely to require these during the study.
- Regular (at least every week) use of recreational drugs including cannabis, as determined through interview with patient.
- History of alcohol or substance dependence within the last 12 months from Visit 1, as assessed using standard screening questions.
Show all 10Show fewer
- Unlikely to be able to complete GP-ETB test.
- Requires immediate referral to secondary care mental health services.
- Is employed by the investigator or is related to the investigator
- Currently taking part in a drug study or another device study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Atherstone Surgery
Atherstone, Warwickshire, CV9 1EU
The Surgery
Burnhope, Northumberland, DH7 0BD
Rosedale Surgery
Carlton Colville, Suffolk, NR33 8LG
Cornerstone Practice
March, Cambridgeshire, PE15 9BF
Harbottle Surgery
Morpeth, Northumberland, NE65 7DG
Oak Street Medical Centre
Norwich, Norfolk, NR3 3DL
Knowle House Surgery
Plymouth, Devon, PL5 3JB
Sherbourne Medical Centre
Royal Leamington Spa, Warwickshire, CV32 4RA
Bradford Road Medical Centre
Trowbridge, Wiltshire, BA14 9AR
Wareham Surgery
Wareham, Dorset, BH20 4PG
About this study
Official title: An Exploratory Investigation in Depressed Patients Initiating Treatment With Citalopram, to Determine the Sensitivity and Specificity of the P1vital® Oxford GP-Emotional Test Battery in Predicting Drug Response and Non-response
In England over 800,000 patients each year are either newly diagnosed with depression or present with a new episode of depression in primary care. The majority of patients do not respond to the first drug prescribed and have to try several different antidepressants before an effective treatment is found. Antidepressants have a slow clinical onset of action, taking 4 to 6 weeks before changes in mood become apparent. No test exists to guide General Practitioners (GPs) as to whether their patient is responding to the prescribed successive treatments. This often results in delays of many months before patients return to good mental health. The GP-ETB is a set of computer-based emotional processing tasks. It was developed and optimised to be sensitive to early changes in emotional bias that are indicative of successful antidepressant treatment. The current investigation is an exploratory study using the GP-ETB.
It will test the predictive ability of the GP-ETB with regard to later subjective drug response and nonresponse. The study will recruit depressed patients from primary care settings. There are no study drugs prescribed as part of this clinical investigation. Eligible patients will have been prescribed citalopram by their GP prior to study entry. The decision to initiate treatment with citalopram will be independent of study participation. The duration of the study is 5 months. Each patient will be required to attend 3 visits and total duration of the study for the patient will be 46 weeks. During the visits patients will be asked to complete a variety of questionnaires and GP-ETB tasks on the computer. Sensitivity and specificity data collected during this study will be used to develop a computer algorithm intended to predict response at 46 weeks, based on GP-ETB data collected 1 week after initiation of antidepressant treatment.
Read the detailed description
The study is an exploratory, single arm, multi-centre, clinical investigation of a medical device. The study consists of a recruitment period followed within 3 days by the first study visit. After a GP has decided to prescribe citalopram for depression, GP assesses patient for suitability for study and provides a brief explanation of study to potentially suitable patient. Patient signs pre-study consent form agreeing to being contacted by researcher from the same or another GP surgery and agreeing not to take their first dose of citalopram until after their first study visit.
Recruitment and pre-screening Main study Patient Information Sheet/Informed Consent Form (PIS/ICF) will be provided. Researcher will contact patient and book the Visit 1 within 3 days from GP visit.
At Visit 1, patients will be screened and eligible patients will be enrolled in the study. Visit 1 procedures include:
- Informed Consent
- Demographics
- Review of other medication
- Brief medical history including depression history (if applicable)
- Entry criteria check and enrolment into study
- Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR)
- Montgomery-Åsberg Depression Rating Scale (MADRS)
- Beck Depression Inventory®II (BDI-II)
- GP-ETB (set of computer tasks)
- Review of Adverse Events (AEs) and Adverse Device Effects (ADEs) and device deficiencies Patients will return approximately 1 week later for Visit 2 and will complete a variety of questionnaires and assessments:
- QIDS-SR
- BDI-II
- GP-ETB
- Assessment of compliance with study prohibitions and restrictions
- Changes to antidepressant medication since last visit (e.g. increased dose, change of drug)
- Concordance with prescribed antidepressant medication, as determined through interview with patient
- Review of other medication
- Review of AEs, ADEs and device deficiencies Visit 3 will be scheduled to take place 46 weeks after the first dose of citalopram. The following questionnaires and assessments will be completed:
- QIDS-SR
- MADRS
- BDI-II
- Acceptability questionnaire(s) relating to use of GP-ETB (patient and researcher)
- Assessment of compliance with study prohibitions and restrictions
- Changes to antidepressant medication since last visit (e.g. increased dose, change of drug)
- Concordance with prescribed antidepressant medication, as determined through interview with patient
- Review of other medication
- Review of AEs, ADEs and device deficiencies At the end of the visit, patients will be considered to have completed the study.
Emotional Test Battery (GP-ETB) tasks: The GP-ETB is a series of computerised tasks during which participants must respond by button press to pictures (e.g. pictures of faces) or words presented on the screen. Some of the pictures are mildly emotional (e.g. a fearful face). Response bias for each Participant choice and reaction times are measured during the following tasks: Emotional Categorisation Task (ECAT) Number of words categorised as liked and disliked
% accuracy for each condition, Reaction time for each condition Emotional Recall Task (EREC) Total number of words recalled for each valence (positive, negative) Number of commission errors
Facial Expression Recognition Task (FERT):
- accuracy of recognition of each emotion (happiness, fear, anger, disgust, surprise, sadness, neutral)
- mis-classifications for each emotion Individual average reaction time for correct answers in each emotion Reaction time for all emotions Target sensitivity for each emotion Response bias for each emotion Questionnaires and rating scales: The questionnaires and rating scales used in the current study, except the acceptability questionnaires relating to use of GP-ETB (patient and researcher), are all validated and commonly used in experimental medicine studies.
The acceptability questionnaires relating to use of GP-ETB were created specifically for this study to obtain a data set for analysis of GP-ETB user satisfaction.
- Conditions
- Depression
- Being tested
- General Practitioner Emotional Test Battery (GP-ETB)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Practitioner Emotional Test Battery (GP-ETB)Device
The GP-ETB (Class I Medical Device) comprises three computer tasks. In the first task, the 'Emotional Categorisation Task' patients are given forty words that might be used to describe them and indicate whether they would 'like' or 'dislike' to be described by a particular word. In the 'Facial Expression Recognition Task' patients are asked to judge whether a briefly displayed face is expressing one of six emotions. In the final task, the 'Emotional Recall Task', the patient should recall as many words as they can from the series of words that were presented in the first task. The patients perform these tasks once before antidepressant treatment and again seven days after treatment begins.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | Study has a single, non-interventional arm where the General Practitioner Emotional Test Battery (GP-ETB) will be administered. Receives: Device: General Practitioner Emotional Test Battery (GP-ETB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) score from baseline (pre-dose of citalopram) to Day 28-42 post first dose of citalopram
The QIDS-SR is a self report questionnaire and will be completed at baseline pre first dose of citalopram and at day 28-42 post first dose of citalopram. Scores will be compared.
Measured: Baseline (pre first dose of citalopram) to day 28-42 post first dose of citalopram)
Change in General Practitioner P1vital Oxford Emotional Test Battery (GP-ETB) scores from baseline (pre first dose of citalopram) to Visit 2 (7-9 days post first dose of citalopram)
Patients will complete the GP-ETB tasks at baseline and 7-9 days post their first dose of citalopram and the scores compared.
Measured: Baseline (pre first dose of citalopram) to day 7-9 post first dose of citalopram)
Secondary outcomes (3)
Change in Montgomery-Asberg Depression rating Scale (MADRS) score from baseline (pre-dose of citalopram) to Day 28-42 post first dose of citalopram
The MADRS interview will be conducted at baseline and again at the end of the study (day 28-42 post first dose of citalopram) and the scores compared.
Measured: Baseline (pre first dose of citalopram) to day 28-42 post first dose of citalopram)
Acceptability questionnaire results
All participants will complete an acceptability questionnaire about ease of use of the medical device.This visit occurs between Day 28 and day 42 after the first dose of citalopram taken by the patient. The data will be subjective text fields and Yes/No answers.
Measured: The questionnaire will be completed at Day 28-42 post first dose of citalopram and will measure the participant's experience of the GP-ETB tests performed during the study
Adverse Events (AEs), Adverse Device Effects (ADEs) and device deficiencies will be recorded at each visit in the participant Case Report Form (CRF)
Assessment of safety will be made through AE's, ADEs and device deficiencies recorded on the Case Report Form for the study first patient enrolled (June 2014) throughout the study until last patient last visit (January 2015). AEs or ADEs that have not resolved by the time a patient leaves the study will be followed up until resolution.
Measured: AEs will be collected per patient from the baseline visit (day 0), from the time the consent form is signed, until study end (28-42 days post first dose of citalopram) or patient withdrawal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- P1vital Products Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Browning, MRCPsych, Principal investigator, P1vital Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800577
- Sponsor's protocol ID
- P1V-DEP-MD01
- Status last verified
- Jun 2016
- First submitted
- 16 Mar 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation in Depressed Patients Initiating Treatment With Citalopram, to Determine the Sensitivity and Specificity of the P1vital® Oxford GP-Emotional Test Battery in Predicting Drug Response and Non-response
- ClinicalTrials.gov ID
- NCT02800577
- Acronym / sponsor ID
- P1V-DEP-MD01
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- P1vital Products LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Jun 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.
In England over 800,000 patients each year are either newly diagnosed with depression or present with a new episode of depression in primary care. The majority of patients do not respond to the first drug prescribed and have to try several different antidepressants before an effective treatment is found. Antidepressants have a slow clinical onset of action, taking 4 to 6 weeks before changes in mood become apparent. No test exists to guide General Practitioners (GPs) as to whether their patient is responding to the prescribed successive treatments. This often results in delays of many months before patients return to good mental health. The GP-ETB is a set of computer-based emotional processing tasks. It was developed and optimised to be sensitive to early changes in emotional bias that are indicative of successful antidepressant treatment. The current investigation is an exploratory study using the GP-ETB.
It will test the predictive ability of the GP-ETB with regard to later subjective drug response and nonresponse. The study will recruit depressed patients from primary care settings. There are no study drugs prescribed as part of this clinical investigation. Eligible patients will have been prescribed citalopram by their GP prior to study entry. The decision to initiate treatment with citalopram will be independent of study participation. The duration of the study is 5 months. Each patient will be required to attend 3 visits and total duration of the study for the patient will be 46 weeks. During the visits patients will be asked to complete a variety of questionnaires and GP-ETB tasks on the computer. Sensitivity and specificity data collected during this study will be used to develop a computer algorithm intended to predict response at 46 weeks, based on GP-ETB data collected 1 week after initiation of antidepressant treatment.
Detailed description
The study is an exploratory, single arm, multi-centre, clinical investigation of a medical device. The study consists of a recruitment period followed within 3 days by the first study visit. After a GP has decided to prescribe citalopram for depression, GP assesses patient for suitability for study and provides a brief explanation of study to potentially suitable patient. Patient signs pre-study consent form agreeing to being contacted by researcher from the same or another GP surgery and agreeing not to take their first dose of citalopram until after their first study visit.
Recruitment and pre-screening Main study Patient Information Sheet/Informed Consent Form (PIS/ICF) will be provided. Researcher will contact patient and book the Visit 1 within 3 days from GP visit.
At Visit 1, patients will be screened and eligible patients will be enrolled in the study. Visit 1 procedures include:
- Informed Consent
- Demographics
- Review of other medication
- Brief medical history including depression history (if applicable)
- Entry criteria check and enrolment into study
- Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR)
- Montgomery-Åsberg Depression Rating Scale (MADRS)
- Beck Depression Inventory®II (BDI-II)
- GP-ETB (set of computer tasks)
- Review of Adverse Events (AEs) and Adverse Device Effects (ADEs) and device deficiencies Patients will return approximately 1 week later for Visit 2 and will complete a variety of questionnaires and assessments:
- QIDS-SR
- BDI-II
- GP-ETB
- Assessment of compliance with study prohibitions and restrictions
- Changes to antidepressant medication since last visit (e.g. increased dose, change of drug)
- Concordance with prescribed antidepressant medication, as determined through interview with patient
- Review of other medication
- Review of AEs, ADEs and device deficiencies Visit 3 will be scheduled to take place 46 weeks after the first dose of citalopram. The following questionnaires and assessments will be completed:
- QIDS-SR
- MADRS
- BDI-II
- Acceptability questionnaire(s) relating to use of GP-ETB (patient and researcher)
- Assessment of compliance with study prohibitions and restrictions
- Changes to antidepressant medication since last visit (e.g. increased dose, change of drug)
- Concordance with prescribed antidepressant medication, as determined through interview with patient
- Review of other medication
- Review of AEs, ADEs and device deficiencies At the end of the visit, patients will be considered to have completed the study.
Emotional Test Battery (GP-ETB) tasks: The GP-ETB is a series of computerised tasks during which participants must respond by button press to pictures (e.g. pictures of faces) or words presented on the screen. Some of the pictures are mildly emotional (e.g. a fearful face). Response bias for each Participant choice and reaction times are measured during the following tasks: Emotional Categorisation Task (ECAT) Number of words categorised as liked and disliked
% accuracy for each condition, Reaction time for each condition Emotional Recall Task (EREC) Total number of words recalled for each valence (positive, negative) Number of commission errors
Facial Expression Recognition Task (FERT):
- accuracy of recognition of each emotion (happiness, fear, anger, disgust, surprise, sadness, neutral)
- mis-classifications for each emotion Individual average reaction time for correct answers in each emotion Reaction time for all emotions Target sensitivity for each emotion Response bias for each emotion Questionnaires and rating scales: The questionnaires and rating scales used in the current study, except the acceptability questionnaires relating to use of GP-ETB (patient and researcher), are all validated and commonly used in experimental medicine studies.
The acceptability questionnaires relating to use of GP-ETB were created specifically for this study to obtain a data set for analysis of GP-ETB user satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Device: General Practitioner Emotional Test Battery (GP-ETB)Study has a single, non-interventional arm where the General Practitioner Emotional Test Battery (GP-ETB) will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female and aged between 18 and 65 inclusive.
- Diagnosed by GP with a depressive episode requiring treatment with citalopram (new or recurrent diagnosis).
- Prescribed citalopram by GP for treatment of depression within past 3 days but has not yet started taking medication.
- Is intending to start citalopram treatment within 2 days of Visit 1.
- Fluent English speaker.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding, or planning to become pregnant during study, as determined through interview with patient.
- Currently taking antidepressant medication.
- Has taken antidepressant medication in the past 3 months.
- Currently taking anti-psychotic or regular sedative medication, or is likely to require these during the study.
- Regular (at least every week) use of recreational drugs including cannabis, as determined through interview with patient.
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 |
|---|---|---|
| General Practitioner Emotional Test Battery (GP-ETB)The GP-ETB (Class I Medical Device) comprises three computer tasks. In the first task, the 'Emotional Categorisation Task' patients are given forty words that might be used to describe them and indicate whether they would 'like' or 'dislike' to be described by a particular word. In the 'Facial Expression Recognition Task' patients are asked to judge whether a briefly displayed face is expressing one of six emotions. In the final task, the 'Emotional Recall Task', the patient should recall as many words as they can from the series of words that were presented in the first task. The patients perform these tasks once before antidepressant treatment and again seven days after treatment begins. | Device | All participants |
Primary outcome
Change in Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) score from baseline (pre-dose of citalopram) to Day 28-42 post first dose of citalopram
Time frame: Baseline (pre first dose of citalopram) to day 28-42 post first dose of citalopram)
The QIDS-SR is a self report questionnaire and will be completed at baseline pre first dose of citalopram and at day 28-42 post first dose of citalopram. Scores will be compared.
Change in General Practitioner P1vital Oxford Emotional Test Battery (GP-ETB) scores from baseline (pre first dose of citalopram) to Visit 2 (7-9 days post first dose of citalopram)
Time frame: Baseline (pre first dose of citalopram) to day 7-9 post first dose of citalopram)
Patients will complete the GP-ETB tasks at baseline and 7-9 days post their first dose of citalopram and the scores compared.
3 secondary outcomes
Change in Montgomery-Asberg Depression rating Scale (MADRS) score from baseline (pre-dose of citalopram) to Day 28-42 post first dose of citalopram
Time frame: Baseline (pre first dose of citalopram) to day 28-42 post first dose of citalopram)
Acceptability questionnaire results
Time frame: The questionnaire will be completed at Day 28-42 post first dose of citalopram and will measure the participant's experience of the GP-ETB tests performed during the study
Adverse Events (AEs), Adverse Device Effects (ADEs) and device deficiencies will be recorded at each visit in the participant Case Report Form (CRF)
Time frame: AEs will be collected per patient from the baseline visit (day 0), from the time the consent form is signed, until study end (28-42 days post first dose of citalopram) or patient withdrawal.
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 15 Jun 2016.
- 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.
Mike Browning, MRCPsych principal investigator
P1vital Limited
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing General Practitioner Emotional Test Battery (GP-ETB) in people with Depression, run by P1vital Products Limited at 10 sites in United Kingdom.
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 11 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 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) score from baseline (pre-dose of citalopram) to Day 28-42 post first dose of citalopram (time frame: Baseline (pre first dose of citalopram) to day 28-42 post first dose of citalopram)). 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?
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 15 Jun 2016.