Generalised Anxiety DisorderPhase 4ToSCANCT02347033
Trial of Sertraline Versus Cognitive Behaviour Therapy for Generalised Anxiety
A Phase 4 study testing Sertraline and Cognitive Behavioural Therapy in people with Generalised Anxiety Disorder, run by University College, London at 1 site in United Kingdom.
Trial summary
Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs people's functioning. It is often chronic and may be accompanied by depression and other anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalised Anxiety Disorder
- What is being tested?
- Sertraline and Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or above
- Positive score of 10+ on GAD-7
- Primary diagnosis of GAD as diagnosed on MINI
- Failure to respond to NICE defined low intensity psychological interventions
Who cannot join
- Inability to complete questionnaires due to insufficient English or cognitive impairment;
- Current major depression
- Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD;
- Significant dependence on alcohol or illicit drugs;
- Comorbid psychotic disorder, bipolar disorder;
- Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months;
Show all 14Show fewer
- Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide;
- Patients with poorly controlled epilepsy;
- Known allergies to the Investigational Medicinal Product (IMP) or excipients;
- Concurrent enrolment in another Investigational Medicinal Product trial;
- Severe hepatic impairment;
- Women who are currently pregnant or planning pregnancy or lactating
- Patient on anti-coagulants
- History of bleeding disorders
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Camden & Islington (with Kingston)
London, WC1X 2DN
About this study
Official title: RCT of Sertraline Versus Cognitive Behavioural Therapy for Anxiety Symptoms in People With Generalised Anxiety Disorder Who Have Failed to Respond to Low Intensity Psychological Interventions as Defined by the NICE GAD Guidelines
Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs people's functioning. It is often chronic and may be accompanied by depression and other anxiety disorders. It is not currently clear whether medication or psychological therapy provides better long term outcomes for those not responding to simpler low intensity treatments so we propose to compare the clinical effectiveness of a pharmacological treatment (the drug Sertraline) with a Cognitive Behavioural Therapy (CBT) intervention.
Our hypothesis is that in people with GAD who have not responded to low intensity psychological interventions, CBT will lead to a greater improvement in their GAD symptoms as measured using the GAD-7 scale at 12 month follow-up than Sertraline.
Read the detailed description
The investigators propose to undertake a randomised controlled trial (RCT) to compare the clinical effectiveness in terms of symptoms and function of a pharmacological treatment (the SSRI Sertraline) prescribed at therapeutic doses, with a manualised psychological intervention (Cognitive Behavioural Therapy, CBT) delivered by trained psychological therapists to patients with persistent generalised anxiety disorder (GAD) which has not improved with low intensity psychological interventions as defined by NICE (the National Institute for Clinical Effectiveness).
The investigators will recruit people via the Increasing Access to Psychological Therapies (IAPT) service from up to 15 sites in England. People still scoring highly on an anxiety measure (GAD-7) despite having received a low intensity psychological intervention will be given a brief flyer about the trial. Names of those interested in taking part who have given written consent to having their details released will be passed to the research team and the IAPT staff will also let the research team know the name of the participant's general practice, with their permission.
The research team will then contact potential participants offering them an appointment for an interview/assessment to discuss the study, sending them a patient information sheet to reach them at least 48 hours beforehand. The study information will explain that the medication being evaluated, Sertraline, although not currently licensed for GAD was recommended by NICE on the basis of its effectiveness in clinical trials and that the study team will be available to clarify any issues arising from this.
At the baseline assessment patients will be asked to give informed consent by a member of the research team and both medical suitability (as confirmed by fax/secure email from the GP) and the meeting of other inclusion/exclusion criteria will be checked. Upon confirmation of eligibility, baseline assessments will be carried out by a member of the research team and consenting patients randomised to receive either the medication or CBT. The Chief Investigator or other medically qualified persons within the research team will review all eligibility information and confirm that the patient is eligible.
Eligible participants will be randomised via an independent web-based computerised system to one of two interventions. The research team will provide the relevant contact details/instructions to patients in order to initiate treatment. The trial interventions consist of: (a) The medication sertraline prescribed by their GP according to a trial protocol matching current clinical recommendations and within a dosage between 25 and 150mg daily. We will ask GPs to review patients regularly (at least 6 times in 12 months) and patients to take the medication for a year unless they have significant adverse effects. Side-effects will be regularly monitored. (b) The other intervention is CBT delivered by high intensity therapists from local IAPT services. They will provide 14 to 16 sessions of a manualised treatment developed for use in GAD and will be trained in its delivery. The primary outcome will be the GAD-7 score measured at 12 months. Participants will also be asked to complete this outcome measure by postal questionnaire at 3, 6 and 9 months, as well as a range of secondary outcomes.
- Conditions
- Generalised Anxiety Disorder
- Being tested
- Sertraline, Cognitive Behavioural Therapy
- Keywords
- Sertraline, Selective Serotonin Reuptake Inhibitor (SSRI), Cognitive Behavioural Therapy (CBT), Increasing Access to Psychological Therapies (IAPT)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called SSRI
Sertraline will be prescribed by the patients' GP, starting at 25mg daily for 1-2 weeks and increasing to 50mg daily if tolerated. The GP should review the patient within the first 2 weeks, checking for acceptability, concordance and any side-effects, with further reviews at 6 and 12 weeks. We expect the usual treatment dose to be 50 to 100mg daily, although some may require 150mg.
We will suggest that the GPs use their usual procedures to review the patient's progress, asking about and noting functional change as well as clinical improvement. Minimal improvement after 12 weeks at a maximal tolerated dose should prompt consideration of change of treatment. If there has been an adequate therapeutic benefit there should be further review at 26 and 52 weeks.
Cognitive Behavioural TherapyBehavioural
Also called CBT
CBT will consist of 14 (+ / - 2) weekly 50-minute sessions and will cover 6 treatment modules: psychoeducation and worry awareness training; re-evaluation of the usefulness of worry; uncertainty recognition and behavioural exposure; problem-solving training; written exposure; and relapse prevention.
Sessions will be digitally recorded and a random 10% assessed for quality (fidelity to the manual and therapist competence) by an independent external assessor according to pre-specified criteria. Patient consent for this will be obtained as part of obtaining informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Active comparator | The pharmacological arm of the trial is the Selective Serotonin Reuptake Inhibitor (SSRI) Sertraline, prescribed at a daily dose of between 25 and 150mg by the patient's general practitioner (GP). If the medication is well tolerated and associated with reported clinical improvement we are asking the patients in this arm to continue taking it for 12 months. Receives: Drug: Sertraline |
| Cognitive Behavioural Therapy (CBT) | Active comparator | The psychological therapy arm of the trial is Cognitive Behavioural Therapy (CBT) delivered by high intensity psychological therapists from local IAPT services. They will provide 14 to 16 sessions of a manualised treatment developed specifically for use in GAD and will be trained in its delivery. Receives: Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD-7
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD).
Measured: GAD-7 score at 12 months
Secondary outcomes (18)
GAD-7
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD).
Measured: GAD-7 score at 3 months
GAD-7
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD).
Measured: GAD-7 score at 6 months
GAD-7
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD).
Measured: GAD-7 score at 9 months
HAM-A
This is a 14 item observer rated anxiety scale which has been widely used, particularly in pharmacological studies widely used, particularly in pharmacological studies
Measured: HAM-A score at 12 months
Patient Health Questionnaire (PHQ-9)
This is a 9 item self-rate scale widely used to monitor the severity of depression.
Measured: PHQ-9 score at 3 months
Patient Health Questionnaire (PHQ-9)
This is a 9 item self-rate scale widely used to monitor the severity of depression.
Measured: PHQ-9 score at 6 months
Patient Health Questionnaire (PHQ-9)
This is a 9 item self-rate scale widely used to monitor the severity of depression.
Measured: PHQ-9 score at 9 months
Patient Health Questionnaire (PHQ-9)
This is a 9 item self-rate scale widely used to monitor the severity of depression.
Measured: PHQ-9 score at 12 months
Work and Social Activity Scale (WASAS)
This is a 5 item self-complete questionnaire which we will use to assess participants' difficulties with physical and social functioning
Measured: WASAS score at 12 months
Euroquol-5 item-3 level (EQ-5D-3L)
5 item, 3 level, self-completed measure of preference based generic health related quality of life. Utility scores calculated at each time point
Measured: Utility score at 3 months
Euroquol-5 item-3 level (EQ-5D-3L)
5 item, 3 level, self-completed measure of preference based generic health related quality of life. Utility scores calculated at each time point scores for Quality Adjusted Life Years
Measured: Utility score at 6 months
Euroquol-5 item-3 level (EQ-5D-3L)
5 item, 3 level, self-completed measure of preference based generic health related quality of life. Utility scores calculated at each time point scores for Quality Adjusted Life Years
Measured: Utility score at 9 months
Euroquol-5 item-3 level (EQ-5D-3L)
5 item, 3 level, self-completed measure of preference based generic health related quality of life. Utility scores calculated at each time point scores for Quality Adjusted Life Years
Measured: Utility score at 12 months
Employment and Social Care Questionnaire (ESC)
Relevant data on services used and productivity losses will be collected using this modified version of the Client Service Receipt Inventory
Measured: ESC score at 6 months
Employment and Social Care Questionnaire (ESC)
Relevant data on services used and productivity losses will be collected using this modified version of the Client Service Receipt Inventory
Measured: ESC score at 12 months
(CSQ) Client Satisfaction Questionnaire
We are going to use the Client Satisfaction Questionnaire, a brief 8-item self-complete questionnaire as our treatment acceptability measure.
Measured: CSQ score at 3 months
(CSQ) Client Satisfaction Questionnaire
We are going to use the Client Satisfaction Questionnaire, a brief 8-item self-complete questionnaire as our treatment acceptability measure.
Measured: CSQ score at 12 months
Patient preference rating scale
We are using a simple 4 item Likert scale used by our team in other studies
Measured: Patient preference rating scale score at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Difficulties with recruitment during the internal pilot phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalised Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Marta Buszewicz, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347033
- Sponsor's protocol ID
- 14/0249
- Acronym
- ToSCA
- Status last verified
- Jul 2016
- First submitted
- 16 Jan 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: To be discussed and decided by the Data Monitoring Committee
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Sertraline Versus Cognitive Behavioural Therapy for Anxiety Symptoms in People With Generalised Anxiety Disorder Who Have Failed to Respond to Low Intensity Psychological Interventions as Defined by the NICE GAD Guidelines
- ClinicalTrials.gov ID
- NCT02347033
- Acronym / sponsor ID
- ToSCA / 14/0249
- Conditions
- Generalised Anxiety Disorder
- Keywords
- Sertraline, Selective Serotonin Reuptake Inhibitor (SSRI), Cognitive Behavioural Therapy (CBT), Increasing Access to Psychological Therapies (IAPT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment during the internal pilot phase
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme, National Institute for Health Research, United Kingdom
- Study start
- Aug 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Jan 2015 (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.
Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs people's functioning. It is often chronic and may be accompanied by depression and other anxiety disorders. It is not currently clear whether medication or psychological therapy provides better long term outcomes for those not responding to simpler low intensity treatments so we propose to compare the clinical effectiveness of a pharmacological treatment (the drug Sertraline) with a Cognitive Behavioural Therapy (CBT) intervention.
Our hypothesis is that in people with GAD who have not responded to low intensity psychological interventions, CBT will lead to a greater improvement in their GAD symptoms as measured using the GAD-7 scale at 12 month follow-up than Sertraline.
Detailed description
The investigators propose to undertake a randomised controlled trial (RCT) to compare the clinical effectiveness in terms of symptoms and function of a pharmacological treatment (the SSRI Sertraline) prescribed at therapeutic doses, with a manualised psychological intervention (Cognitive Behavioural Therapy, CBT) delivered by trained psychological therapists to patients with persistent generalised anxiety disorder (GAD) which has not improved with low intensity psychological interventions as defined by NICE (the National Institute for Clinical Effectiveness).
The investigators will recruit people via the Increasing Access to Psychological Therapies (IAPT) service from up to 15 sites in England. People still scoring highly on an anxiety measure (GAD-7) despite having received a low intensity psychological intervention will be given a brief flyer about the trial. Names of those interested in taking part who have given written consent to having their details released will be passed to the research team and the IAPT staff will also let the research team know the name of the participant's general practice, with their permission.
The research team will then contact potential participants offering them an appointment for an interview/assessment to discuss the study, sending them a patient information sheet to reach them at least 48 hours beforehand. The study information will explain that the medication being evaluated, Sertraline, although not currently licensed for GAD was recommended by NICE on the basis of its effectiveness in clinical trials and that the study team will be available to clarify any issues arising from this.
At the baseline assessment patients will be asked to give informed consent by a member of the research team and both medical suitability (as confirmed by fax/secure email from the GP) and the meeting of other inclusion/exclusion criteria will be checked. Upon confirmation of eligibility, baseline assessments will be carried out by a member of the research team and consenting patients randomised to receive either the medication or CBT. The Chief Investigator or other medically qualified persons within the research team will review all eligibility information and confirm that the patient is eligible.
Eligible participants will be randomised via an independent web-based computerised system to one of two interventions. The research team will provide the relevant contact details/instructions to patients in order to initiate treatment. The trial interventions consist of: (a) The medication sertraline prescribed by their GP according to a trial protocol matching current clinical recommendations and within a dosage between 25 and 150mg daily. We will ask GPs to review patients regularly (at least 6 times in 12 months) and patients to take the medication for a year unless they have significant adverse effects. Side-effects will be regularly monitored. (b) The other intervention is CBT delivered by high intensity therapists from local IAPT services. They will provide 14 to 16 sessions of a manualised treatment developed for use in GAD and will be trained in its delivery. The primary outcome will be the GAD-7 score measured at 12 months. Participants will also be asked to complete this outcome measure by postal questionnaire at 3, 6 and 9 months, as well as a range of secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Active comparator | Drug: SertralineThe pharmacological arm of the trial is the Selective Serotonin Reuptake Inhibitor (SSRI) Sertraline, prescribed at a daily dose of between 25 and 150mg by the patient's general practitioner (GP). If the medication is well tolerated and associated with reported clinical improvement we are asking the patients in this arm to continue taking it for 12 months. |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioural TherapyThe psychological therapy arm of the trial is Cognitive Behavioural Therapy (CBT) delivered by high intensity psychological therapists from local IAPT services. They will provide 14 to 16 sessions of a manualised treatment developed specifically for use in GAD and will be trained in its delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or above
- Positive score of 10+ on GAD-7
- Primary diagnosis of GAD as diagnosed on MINI
- Failure to respond to NICE defined low intensity psychological interventions
Key exclusion criteria (14 listed)
- Inability to complete questionnaires due to insufficient English or cognitive impairment;
- Current major depression
- Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD;
- Significant dependence on alcohol or illicit drugs;
- Comorbid psychotic disorder, bipolar disorder;
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 |
|---|---|---|
| SertralineAlso: SSRISertraline will be prescribed by the patients' GP, starting at 25mg daily for 1-2 weeks and increasing to 50mg daily if tolerated. The GP should review the patient within the first 2 weeks, checking for acceptability, concordance and any side-effects, with further reviews at 6 and 12 weeks. We expect the usual treatment dose to be 50 to 100mg daily, although some may require 150mg. We will suggest that the GPs use their usual procedures to review the patient's progress, asking about and noting functional change as well as clinical improvement. Minimal improvement after 12 weeks at a maximal tolerated dose should prompt consideration of change of treatment. If there has been an adequate therapeutic benefit there should be further review at 26 and 52 weeks. | Drug | Sertraline |
| Cognitive Behavioural TherapyAlso: CBTCBT will consist of 14 (+ / - 2) weekly 50-minute sessions and will cover 6 treatment modules: psychoeducation and worry awareness training; re-evaluation of the usefulness of worry; uncertainty recognition and behavioural exposure; problem-solving training; written exposure; and relapse prevention. Sessions will be digitally recorded and a random 10% assessed for quality (fidelity to the manual and therapist competence) by an independent external assessor according to pre-specified criteria. Patient consent for this will be obtained as part of obtaining informed consent. | Behavioural | Cognitive Behavioural Therapy (CBT) |
Primary outcome
GAD-7
Time frame: GAD-7 score at 12 months
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD).
18 secondary outcomes
GAD-7
Time frame: GAD-7 score at 3 months
GAD-7
Time frame: GAD-7 score at 6 months
GAD-7
Time frame: GAD-7 score at 9 months
HAM-A
Time frame: HAM-A score at 12 months
Patient Health Questionnaire (PHQ-9)
Time frame: PHQ-9 score at 3 months
Patient Health Questionnaire (PHQ-9)
Time frame: PHQ-9 score at 6 months
Patient Health Questionnaire (PHQ-9)
Time frame: PHQ-9 score at 9 months
Patient Health Questionnaire (PHQ-9)
Time frame: PHQ-9 score at 12 months
Work and Social Activity Scale (WASAS)
Time frame: WASAS score at 12 months
Euroquol-5 item-3 level (EQ-5D-3L)
Time frame: Utility score at 3 months
Euroquol-5 item-3 level (EQ-5D-3L)
Time frame: Utility score at 6 months
Euroquol-5 item-3 level (EQ-5D-3L)
Time frame: Utility score at 9 months
Euroquol-5 item-3 level (EQ-5D-3L)
Time frame: Utility score at 12 months
Employment and Social Care Questionnaire (ESC)
Time frame: ESC score at 6 months
Employment and Social Care Questionnaire (ESC)
Time frame: ESC score at 12 months
(CSQ) Client Satisfaction Questionnaire
Time frame: CSQ score at 3 months
(CSQ) Client Satisfaction Questionnaire
Time frame: CSQ score at 12 months
Patient preference rating scale
Time frame: Patient preference rating scale score at 12 months
Results and safety
The study was stopped early (reason given: Difficulties with recruitment during the internal pilot phase). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Individual participant dataSharing planned: Undecided. To be discussed and decided by the Data Monitoring Committee
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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.
Marta Buszewicz principal investigator
University College, London
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 Sertraline and Cognitive Behavioural Therapy in people with Generalised Anxiety Disorder, run by University College, London at 1 site 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 4 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: stopped early, as of the sponsor's last update on 11 Jul 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 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 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?
The study was stopped early (reason given: Difficulties with recruitment during the internal pilot phase). Results are not available in the source record.
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?
GAD-7 (time frame: GAD-7 score at 12 months). 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 11 Jul 2016.