Dual DiagnosisNCT02404662
Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
A study testing Supportive text messages intervention in people with Dual Diagnosis, run by St Patrick's Hospital, Ireland at 1 site in Ireland.
Trial summary
Most patients who present with problem drinking also present with mood problems. Problem drinking and mood problems co-occurring together in individuals lead them to have more severe symptoms, greater disability and poorer quality of life than individuals with only problem drinking, and they pose a greater economic… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dual Diagnosis
- What is being tested?
- Supportive text messages intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2015to Sep 2018
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) and are enrolled on the in-patient dual diagnosis or addiction treatment programmes in St. Patrick's University Hospital.
- Able to provide written, informed consent.
- Mini-mental state examination (MMSE) score of ≥ 25
- Patients who have a mobile phone, are familiar with SMS text messaging technology and are willing to take part in the study.
Who cannot join
- Patients who do not consent to take part in the study.
- Patients who do not have a mobile phone or are unable to use the mobile text message technology.
- Patients who would be unavailable for follow-up during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Blind Randomised Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
Most patients who present with problem drinking also present with mood problems. Problem drinking and mood problems co-occurring together in individuals lead them to have more severe symptoms, greater disability and poorer quality of life than individuals with only problem drinking, and they pose a greater economic burden to society due to their higher use of health services. This study aims to assess the efficacy of a new, innovative and cost effective treatment strategy aimed at reducing the burden that these co-occurring conditions impose on the suffers and their families as well as the community and health systems.
In a recent pilot study of supportive text messages for patients with problem drinking and co-occurring depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher alcohol free days than those who did not receive any supportive text messages.
This study seeks to extend the knowledge gained from the pilot study. A larger group of patients with alcohol use disorder and a depressive disorder will be randomly assigned to two groups. One group will receive supportive text messages for six months duration whilst the other group will receive no supportive text messages. The patients will be followed up at 3, 6, 9 and 12 months to determine which of the two groups have less alcohol and mood problems. It is anticipated that patients receiving supportive text messages will report significantly greater alcohol free days as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages.
Read the detailed description
Co-morbidity of alcohol use disorder (AUD) and mood disorders presents a great challenge to health systems and exacts a tremendous toll world-wide. Individuals with a dual diagnosis have more severe symptoms, greater disability and poor quality of life than those with either diagnosis alone, and pose a greater economic burden to society due to their higher use of treatment services. New, enhanced, efficient, innovative and cost effective treatment strategies aimed at reducing the burden that the disorders impose on the suffers and their families as well as the community and health systems are required. In a pilot trial of supportive text messages for patients with alcohol use disorders and co-morbid depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher cumulative abstinence duration than those who did not receive any supportive text messages.
This research seeks to extend the knowledge gained from the pilot trial. A randomised trial will be conducted on a larger sample size of patients with alcohol use disorder and a co-morbid depressive disorder (including bipolar depression) for an extended duration (6 months of supportive text messages and 1 year follow-up instead of 3 months text messages with 6 months follow-up in the pilot trial). It is hypothesised that patients receiving supportive text messages will report significantly greater cumulative abstinence duration as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages. It is anticipated that this technology intervention for relapse prevention will be acceptable to patients as well as cost effective.
- Conditions
- Dual Diagnosis
- Being tested
- Supportive text messages intervention, Control group
- Keywords
- Alcohol use disorder, Depression, Mood disorders, Bipolar disorder, Supportive text messages
- Medical subject headings
- Alcoholism, Depression, Mood Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive text messages interventionOther
The supportive text messages are based on existing aphorisms in the recovery literature. Each day patients will receive one message targeting mood and another message targeting abstinence from alcohol in accordance with the primary aims of our study. An example text message aimed at improving mood is: "Monitor changes in your mood; develop a list of personal warning signs." An example message targeting abstinence is: "Keep Sobriety as a number one priority and you will reach your goals. None of the messages will be repeated. The messages will be sent in the morning and evening, with the theme (mood/alcohol) of the messages pseudo-randomised according to delivery time, so that no more than three successive days will have the same theme sent at the same time slot.
Control groupOther
The control group will receive treatment as usual, as well as fortnightly thank you text messages and calls to ensure that they are still using their phone.
| Study group | Role | What they receive |
|---|---|---|
| Supportive text messages intervention | Experimental | Patients in the intervention group will receive twice daily supportive text messages to their mobile phone for 6 months following discharge from a 4-week in-patient dual diagnosis treatment programme. The messages will be sent by a computer programme at 10am and 7pm each day and will be set up and monitored by the research worker who will not participate in follow-up assessments. They will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The intervention group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings. Receives: Other: Supportive text messages intervention |
| Control group | Active comparator | Patients in the control group will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The control group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative abstinence duration (CAD).
CAD will be assessed using the timeline to follow-back (TLFB). This will be used to record the quantity of alcohol consumed and number of drinking days.
Measured: 12 months following discharge from the inpatient treatment programme.
Changes in Beck's Depression Inventory (BDI) scores from baseline.
The BDI is a self-administered questionnaire widely used to assess depressive symptoms. It takes approximately 5 minutes to complete.
Measured: BDI will be administered at baseline (during the in-patient treatment programme for dual diagnosis), and then at 3, 6, 9 and 12 months post-discharge from hospital.
Secondary outcomes (11)
Proportion of patients continuously abstinent from alcohol at 6 and 12 months.
Continuous abstinence will be assessed using the TLFB.
Measured: 6 and 12 months post-discharge.
Time to first drink.
The time between the patient's discharge from hospital and their first drink, if any, during the study, will be measured using the TLFB.
Measured: 3, 6, 9 and 12 months post-discharge.
Perception of patients in the intervention group about the usefulness of supportive text messages.
Patient perceptions about the usefulness of the intervention will be assessed at the end of the intervention period in an interview.
Measured: 6 months post-discharge
Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.
The m-GAF will be used to measure subjective changes in the social, occupational and psychological functioning of the patients over the course of the study.
Measured: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the alcohol expectancy questionnaire (AEQ).
This scale will measure changes in attitudes towards alcohol over the course of the study.
Measured: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the obsessive compulsive drinking scale (OCDS).
This scale will measure changes in obsessive compulsive thoughts about alcohol over the 12 months of the study.
Measured: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the alcohol abstinence self-efficacy scale (AASES).
This scale will measure changes in feelings of self-efficacy and personal control around drinking over the 12 months of the study.
Measured: These scales will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the perceived stress scale (PSS).
This scale will measure changes in perceived stress over the 12 months of the study. This construct is closely related to resilience, which is a positive predictor of recovery in addiction.
Measured: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the young mania rating scale (YMRS).
This subjective rating scale assesses the level of mania in patients with bipolar disorder (BP). It will be used to track changes in the manic symptoms of the BP patients over the 12 months of the study.
Measured: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in blood measures of alcohol abuse.
Three blood measures suggestive of alcohol abuse will be taken to corroborate self-report measures of alcohol intake or abstinence from the TLFB- gamma glutamyl transferase (GGT), alkaline phosphatase (AST) and mean corpuscular volume (MCV).
Measured: Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.
Patient satisfaction with overall treatment protocol in both groups
Patient satisfaction will be assessed using an adaptation of a treatment evaluation questionnaire.
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dual DiagnosisStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Patrick's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Responsible party
- Principal investigator, Dr. Conor Farren, St Patrick's Hospital, Ireland
- Investigators
- Conor Farren, PhD,MRCPsych, Principal investigator, St Patrick's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404662
- Sponsor's protocol ID
- HRA-POR-2014-598
- Status last verified
- May 2017
- First submitted
- 19 Mar 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Agyapong VI, Ahern S, McLoughlin DM, Farren CK. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. J Affect Disord. 2012 Dec 10;141(2-3):168-76. doi: 10.1016/j.jad.2012.02.040. Epub 2012 Mar 29.
PubMed 22464008Agyapong VI, McLoughlin DM, Farren CK. Six-months outcomes of a randomised trial of supportive text messaging for depression and comorbid alcohol use disorder. J Affect Disord. 2013 Oct;151(1):100-4. doi: 10.1016/j.jad.2013.05.058. Epub 2013 Jun 22.
PubMed 23800443Agyapong VI, Milnes J, McLoughlin DM, Farren CK. Perception of patients with alcohol use disorder and comorbid depression about the usefulness of supportive text messages. Technol Health Care. 2013;21(1):31-9. doi: 10.3233/THC-120707.
PubMed 23358057Hartnett D, Murphy E, Kehoe E, Agyapong V, McLoughlin DM, Farren C. Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial. BMJ Open. 2017 May 29;7(5):e013587. doi: 10.1136/bmjopen-2016-013587.
PubMed 28554910
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind Randomised Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
- ClinicalTrials.gov ID
- NCT02404662
- Acronym / sponsor ID
- HRA-POR-2014-598
- Conditions
- Dual Diagnosis
- Keywords
- Alcohol use disorder, Depression, Mood disorders, Bipolar disorder, Supportive text messages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (actual)
- Lead sponsor
- St Patrick's Hospital, IrelandUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Study start
- Mar 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 31 Mar 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.
Most patients who present with problem drinking also present with mood problems. Problem drinking and mood problems co-occurring together in individuals lead them to have more severe symptoms, greater disability and poorer quality of life than individuals with only problem drinking, and they pose a greater economic burden to society due to their higher use of health services. This study aims to assess the efficacy of a new, innovative and cost effective treatment strategy aimed at reducing the burden that these co-occurring conditions impose on the suffers and their families as well as the community and health systems.
In a recent pilot study of supportive text messages for patients with problem drinking and co-occurring depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher alcohol free days than those who did not receive any supportive text messages.
This study seeks to extend the knowledge gained from the pilot study. A larger group of patients with alcohol use disorder and a depressive disorder will be randomly assigned to two groups. One group will receive supportive text messages for six months duration whilst the other group will receive no supportive text messages. The patients will be followed up at 3, 6, 9 and 12 months to determine which of the two groups have less alcohol and mood problems. It is anticipated that patients receiving supportive text messages will report significantly greater alcohol free days as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages.
Detailed description
Co-morbidity of alcohol use disorder (AUD) and mood disorders presents a great challenge to health systems and exacts a tremendous toll world-wide. Individuals with a dual diagnosis have more severe symptoms, greater disability and poor quality of life than those with either diagnosis alone, and pose a greater economic burden to society due to their higher use of treatment services. New, enhanced, efficient, innovative and cost effective treatment strategies aimed at reducing the burden that the disorders impose on the suffers and their families as well as the community and health systems are required. In a pilot trial of supportive text messages for patients with alcohol use disorders and co-morbid depression, the investigators established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend to finding that patients who received the supportive text messages were more likely to have higher cumulative abstinence duration than those who did not receive any supportive text messages.
This research seeks to extend the knowledge gained from the pilot trial. A randomised trial will be conducted on a larger sample size of patients with alcohol use disorder and a co-morbid depressive disorder (including bipolar depression) for an extended duration (6 months of supportive text messages and 1 year follow-up instead of 3 months text messages with 6 months follow-up in the pilot trial). It is hypothesised that patients receiving supportive text messages will report significantly greater cumulative abstinence duration as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages. It is anticipated that this technology intervention for relapse prevention will be acceptable to patients as well as cost effective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive text messages intervention | Experimental | Other: Supportive text messages interventionPatients in the intervention group will receive twice daily supportive text messages to their mobile phone for 6 months following discharge from a 4-week in-patient dual diagnosis treatment programme. The messages will be sent by a computer programme at 10am and 7pm each day and will be set up and monitored by the research worker who will not participate in follow-up assessments. They will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The intervention group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings. |
| Control group | Active comparator | Other: Control groupPatients in the control group will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The control group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) and are enrolled on the in-patient dual diagnosis or addiction treatment programmes in St. Patrick's University Hospital.
- Able to provide written, informed consent.
- Mini-mental state examination (MMSE) score of ≥ 25
- Patients who have a mobile phone, are familiar with SMS text messaging technology and are willing to take part in the study.
Key exclusion criteria (3 listed)
- Patients who do not consent to take part in the study.
- Patients who do not have a mobile phone or are unable to use the mobile text message technology.
- Patients who would be unavailable for follow-up during the study period
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 |
|---|---|---|
| Supportive text messages interventionThe supportive text messages are based on existing aphorisms in the recovery literature. Each day patients will receive one message targeting mood and another message targeting abstinence from alcohol in accordance with the primary aims of our study. An example text message aimed at improving mood is: "Monitor changes in your mood; develop a list of personal warning signs." An example message targeting abstinence is: "Keep Sobriety as a number one priority and you will reach your goals. None of the messages will be repeated. The messages will be sent in the morning and evening, with the theme (mood/alcohol) of the messages pseudo-randomised according to delivery time, so that no more than three successive days will have the same theme sent at the same time slot. | Other | Supportive text messages intervention |
| Control groupThe control group will receive treatment as usual, as well as fortnightly thank you text messages and calls to ensure that they are still using their phone. | Other | Control group |
Primary outcome
Cumulative abstinence duration (CAD).
Time frame: 12 months following discharge from the inpatient treatment programme.
CAD will be assessed using the timeline to follow-back (TLFB). This will be used to record the quantity of alcohol consumed and number of drinking days.
Changes in Beck's Depression Inventory (BDI) scores from baseline.
Time frame: BDI will be administered at baseline (during the in-patient treatment programme for dual diagnosis), and then at 3, 6, 9 and 12 months post-discharge from hospital.
The BDI is a self-administered questionnaire widely used to assess depressive symptoms. It takes approximately 5 minutes to complete.
11 secondary outcomes
Proportion of patients continuously abstinent from alcohol at 6 and 12 months.
Time frame: 6 and 12 months post-discharge.
Time to first drink.
Time frame: 3, 6, 9 and 12 months post-discharge.
Perception of patients in the intervention group about the usefulness of supportive text messages.
Time frame: 6 months post-discharge
Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.
Time frame: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the alcohol expectancy questionnaire (AEQ).
Time frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the obsessive compulsive drinking scale (OCDS).
Time frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the alcohol abstinence self-efficacy scale (AASES).
Time frame: These scales will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the perceived stress scale (PSS).
Time frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in scores on the young mania rating scale (YMRS).
Time frame: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Changes from baseline in blood measures of alcohol abuse.
Time frame: Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.
Patient satisfaction with overall treatment protocol in both groups
Time frame: 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Background: PubMed 22464008Agyapong VI, Ahern S, McLoughlin DM, Farren CK. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. J Affect Disord. 2012 Dec 10;141(2-3):168-76. doi: 10.1016/j.jad.2012.02.040. Epub 2012 Mar 29.
- Background: PubMed 23800443Agyapong VI, McLoughlin DM, Farren CK. Six-months outcomes of a randomised trial of supportive text messaging for depression and comorbid alcohol use disorder. J Affect Disord. 2013 Oct;151(1):100-4. doi: 10.1016/j.jad.2013.05.058. Epub 2013 Jun 22.
- Background: PubMed 23358057Agyapong VI, Milnes J, McLoughlin DM, Farren CK. Perception of patients with alcohol use disorder and comorbid depression about the usefulness of supportive text messages. Technol Health Care. 2013;21(1):31-9. doi: 10.3233/THC-120707.
- Derived from this study: PubMed 28554910Hartnett D, Murphy E, Kehoe E, Agyapong V, McLoughlin DM, Farren C. Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial. BMJ Open. 2017 May 29;7(5):e013587. doi: 10.1136/bmjopen-2016-013587.
- 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.
Conor Farren, PhD,MRCPsych principal investigator
St Patrick's Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive text messages intervention in people with Dual Diagnosis, run by St Patrick's Hospital, Ireland at 1 site in Ireland.
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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2017. 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 Ireland. 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?
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?
Cumulative abstinence duration (CAD). (time frame: 12 months following discharge from the inpatient treatment programme.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404662, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.