DepressionNCT00468676

Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression

A study testing Nurse-led case management and Treatment as usual in people with Depression, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Depression
What is being tested?: Nurse-led case management and Treatment as usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 1 siteUnited States
Study dates: May 2007to Aug 2012
Phase: Interventional
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of diabetes and/or heart disease
Poor disease control (defined as an HbA1c level of at least 8.5%, blood pressure greater than 140/90 mm Hg, LDL cholesterol greater than 130 mg/dL)
Diagnosis of major depressive disorder

Who cannot join

History of psychosis
At high risk for suicide
Cognitive impairment
Current alcohol or substance abuse disorder
Does not own a telephone
Currently seeking psychiatric care

Show all 11Show fewer

Pregnant or breastfeeding
Currently enrolled in a Group Health Cooperative disease management program
Terminal illness
Plans to leave Group Health Cooperative in less than a year
Does not speak English

Trial locations and contacts

1 site in 1 country.

United States1 site

Group Health Cooperative
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Randomized Trial of Liaison Psychiatry in Primary Care

Read the detailed description

Depression is a serious medical illness that has been associated with increased risk for heart disease and diabetes. Depression may negatively impact aspects of self-care that are required to effectively manage such long-term diseases. In depressed people who have heart disease and/or diabetes, treatment for depression appears to result in only limited improvements in depression symptoms and no improvements in heart disease and diabetes symptoms. An integrated treatment approach may be more effective in improving all three conditions. This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Participants in this single-blind study will be randomly assigned to take part in the case management intervention or receive usual care. All participants will attend 5 in-person study evaluation visits and receive 4 follow-up phone calls over 24 months. At each of the study visits, measurements of height, weight, waist size, and blood pressure will be taken. At study evaluations, blood and urine samples will also be taken. Participants will be asked not to eat for 8 hours before providing blood samples at 3 of the visits. During follow-up phone calls participants will answer various questions.

The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. Outcomes will be measured at Months 6, 12, 18, and 24 months.

Conditions: Depression
Being tested: Nurse-led case management, Treatment as usual
Keywords: major Depressive Disorder, Diabetes, Heart Disease
Medical subject headings: Depression, Depressive Disorder, Major, Diabetes Mellitus, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nurse-led case managementBehavioural
The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.
Treatment as usualBehavioural
Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.

Study groups in NCT00468676
Study group	Role	What they receive
B	Active comparator	Treatment as usual Receives: Behavioral: Treatment as usual
A	Experimental	Case management intervention Receives: Behavioral: Nurse-led case management

What is being measured

The primary outcome is the main question the study is designed to answer.

Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c
A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.
Measured: Baseline to 12 months
Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months
SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured: Measured at Baseline, 6 Months, 12 months
Systolic Blood Pressure at Baseline, 6 Months and 12 Months
Systolic Blood Pressure was measured at Baseline, 6 months and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured: Measured at Baseline, 6 Months, 12 months
LDL Cholesterol at Baseline and 12 Months
LDL Cholesterol was measured at Baseline and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured: Measured at Baseline and 12 months
Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months
Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured: Measured at Baseline, 6 months and 12 months

Secondary outcomes (2)

Functional Impairment
Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is "not at all" and 10 is "extremely". This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10.
Measured: Measured at Months 6, 12 months
Health Care Costs
Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs
Measured: Cumulative outpatient costs over 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Aug 2012

First posted3 May 2007 (estimated)
Study startMay 2007
Primary completionOct 2010
Study completionAug 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.
Publications (5)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 WashingtonThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00468676
Sponsor's protocol ID: R01MH041739
Other IDs: R01MH041739, DSIR 82-SEPC
Status last verified: May 2014
First submitted: 1 May 2007
Last updated: 2 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
PubMed 21190455
Lin EH, Von Korff M, Ciechanowski P, Peterson D, Ludman EJ, Rutter CM, Oliver M, Young BA, Gensichen J, McGregor M, McCulloch DK, Wagner EH, Katon WJ. Treatment adjustment and medication adherence for complex patients with diabetes, heart disease, and depression: a randomized controlled trial. Ann Fam Med. 2012 Jan-Feb;10(1):6-14. doi: 10.1370/afm.1343.
PubMed 22230825
Von Korff M, Katon WJ, Lin EH, Ciechanowski P, Peterson D, Ludman EJ, Young B, Rutter CM. Functional outcomes of multi-condition collaborative care and successful ageing: results of randomised trial. BMJ. 2011 Nov 10;343:d6612. doi: 10.1136/bmj.d6612.
PubMed 22074851
Katon W, Russo J, Lin EH, Schmittdiel J, Ciechanowski P, Ludman E, Peterson D, Young B, Von Korff M. Cost-effectiveness of a multicondition collaborative care intervention: a randomized controlled trial. Arch Gen Psychiatry. 2012 May;69(5):506-14. doi: 10.1001/archgenpsychiatry.2011.1548.
PubMed 22566583
Ludman EJ, Peterson D, Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Young B, Gensichen J. Improving confidence for self care in patients with depression and chronic illnesses. Behav Med. 2013;39(1):1-6. doi: 10.1080/08964289.2012.708682.
PubMed 23398269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Liaison Psychiatry in Primary Care
ClinicalTrials.gov ID: NCT00468676
Acronym / sponsor ID: R01MH041739
Conditions: Depression
Keywords: major Depressive Disorder, Diabetes, Heart Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 214 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: May 2007
Primary completion: Oct 2010 (actual)
Study completion: Aug 2012 (actual)
First posted: 3 May 2007 (estimated)
Results: Posted 2 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
B	Active comparator	Behavioral: Treatment as usualTreatment as usual
A	Experimental	Behavioral: Nurse-led case managementCase management intervention

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of diabetes and/or heart disease
Poor disease control (defined as an HbA1c level of at least 8.5%, blood pressure greater than 140/90 mm Hg, LDL cholesterol greater than 130 mg/dL)
Diagnosis of major depressive disorder

Key exclusion criteria (11 listed)

History of psychosis
At high risk for suicide
Cognitive impairment
Current alcohol or substance abuse disorder
Does not own a telephone

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
Nurse-led case managementThe case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.	Behavioural	A
Treatment as usualParticipants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.	Behavioural	B

Primary outcome

Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c
Time frame: Baseline to 12 months
A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.
Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months
Time frame: Measured at Baseline, 6 Months, 12 months
SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms. For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Systolic Blood Pressure at Baseline, 6 Months and 12 Months
Time frame: Measured at Baseline, 6 Months, 12 months
Systolic Blood Pressure was measured at Baseline, 6 months and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
LDL Cholesterol at Baseline and 12 Months
Time frame: Measured at Baseline and 12 months
LDL Cholesterol was measured at Baseline and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months
Time frame: Measured at Baseline, 6 months and 12 months
Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.

2 secondary outcomes

Functional Impairment
Time frame: Measured at Months 6, 12 months
Health Care Costs
Time frame: Cumulative outpatient costs over 24 months

Results and safety

Results posted to the registry on 2 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	108	92
Care Management Intervention	106	94

Primary outcome: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c

Time frame: Baseline to 12 months. Number (95% Confidence Interval). Unit: unitless

Measure	Effect Size of Invervention Group to Standard Care n = 214
Value	-1.57 (0.66)

Effect Size of Invervention Group to Standard Care: scaled marginal model parameter: -1.57 (95% CI -2.12 to -1.02), p = .001, Scaled Marginal Model

Population analysed: This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes

Primary outcome: Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months

Time frame: Measured at Baseline, 6 Months, 12 months. Mean (Standard Deviation). Unit: scores on a scale

Measure	Usual Care n = 106	Care Management Intervention n = 105
SCL-20 at Baseline	1.65 (0.60)	1.74 (0.59)
SCL-20 at 6 mos	1.26 (0.72)	0.84 (0.68)
SCL-20 at 12 mos	1.14 (0.66)	0.83 (0.68)

Usual Care vs Care Management Intervention: Estimated Between Group Difference: -0.41 (95% CI -0.56 to -0.26), p <0.001, Generalized-Estimating-Equation Model

Population analysed: This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes

Primary outcome: Systolic Blood Pressure at Baseline, 6 Months and 12 Months

Time frame: Measured at Baseline, 6 Months, 12 months. Mean (Standard Deviation). Unit: mmHg

Measure	Usual Care n = 106	Care Management Intervention n = 105
Systolic Blood Pressure at Baseline	131.9 (17.0)	135.7 (18.4)
Systolic Blood Pressure at 6 months	133.5 (20.4)	131.9 (15.2)
Systolic Blood Pressure at 12 months	132.3 (17.4)	131.0 (18.2)

Usual Care vs Care Management Intervention: Estimated Between Group Difference: -3.4 (95% CI -6.9 to 0.1), Generalized-Estimating-Equation Model

Population analysed: This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes

Primary outcome: LDL Cholesterol at Baseline and 12 Months

Time frame: Measured at Baseline and 12 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Usual Care n = 106	Care Management Intervention n = 105
LDL cholesterol at Baseline	109.4 (36.7)	106.8 (35.4)
LDL cholesterol at 12 months	101.4 (36.6)	91.9 (36.7)

Usual Care vs Care Management Intervention: Estimated Between Group Difference: -9.1 (95% CI -17.5 to -0.8), Regression, Linear

Population analysed: This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	2 of 108 (1.9%)	23 of 106 (21.7%)	Not reported
Care Management Intervention	1 of 106 (0.9%)	27 of 105 (25.7%)	Not reported

Limitations and caveats (from the sponsor): Limitations include the study being completed in one health care system in one geographic area, inadequate power to determine cardiovascular events or rates of hospitalization, potential "spill-over of intervention to usual care patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21190455Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
Results publication: PubMed 22230825Lin EH, Von Korff M, Ciechanowski P, Peterson D, Ludman EJ, Rutter CM, Oliver M, Young BA, Gensichen J, McGregor M, McCulloch DK, Wagner EH, Katon WJ. Treatment adjustment and medication adherence for complex patients with diabetes, heart disease, and depression: a randomized controlled trial. Ann Fam Med. 2012 Jan-Feb;10(1):6-14. doi: 10.1370/afm.1343.
Results publication: PubMed 22074851Von Korff M, Katon WJ, Lin EH, Ciechanowski P, Peterson D, Ludman EJ, Young B, Rutter CM. Functional outcomes of multi-condition collaborative care and successful ageing: results of randomised trial. BMJ. 2011 Nov 10;343:d6612. doi: 10.1136/bmj.d6612.
Results publication: PubMed 22566583Katon W, Russo J, Lin EH, Schmittdiel J, Ciechanowski P, Ludman E, Peterson D, Young B, Von Korff M. Cost-effectiveness of a multicondition collaborative care intervention: a randomized controlled trial. Arch Gen Psychiatry. 2012 May;69(5):506-14. doi: 10.1001/archgenpsychiatry.2011.1548.
Derived from this study: PubMed 23398269Ludman EJ, Peterson D, Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Young B, Gensichen J. Improving confidence for self care in patients with depression and chronic illnesses. Behav Med. 2013;39(1):1-6. doi: 10.1080/08964289.2012.708682.
Related InfoLink provided by the sponsor.

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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.

Wayne J. Katon, MD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-led case management and Treatment as usual in people with Depression, run by University of Washington 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 3 inclusion and 11 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 2 May 2014. 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 2 May 2014). 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?

Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (time frame: Baseline to 12 months). The study lists 5 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 NCT00468676, which also lists 5 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 2 May 2014.