Attention Deficit Disorder With Hyperactivity (ADHD)ADAPTNCT02136147
ADHD Medication and Predictors of Treatment Outcome
An observational study of Attention Deficit Disorder With Hyperactivity (ADHD), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
ADHD medication of children and adolescents is becoming increasingly common. Clinical experience and scientific studies have proven that approximately 30% of children/adolescents with ADHD do not benefit from this treatment. However, there is insufficient knowledge about who these children are. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- methylphenidate medication, atomoxetine medication and lisdexamphetamine medication
- How many people
- 632 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2015to Jun 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children/adolescents starting ADHD medication at the public child and adolescent psychiatry services in Stockholm and on Gotland
Who may be able to join
- Clinical diagnosis of ADHD
- Starting medication against ADHD symptoms with atomoxetine, methylphenidate, lisdexamphetamine, or guanfacine
- Exclusion Criteria: Any medication against ADHD the last 3 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Division for Child and Adolescent Psychiatry in Stockholm
Stockholm, Stockholm County
About this study
Official title: Naturalistic Study of ADHD Medication and Predictors of Treatment Outcome
ADHD medication of children and adolescents is becoming increasingly common. Clinical experience and scientific studies have proven that approximately 30% of children/adolescents with ADHD do not benefit from this treatment. However, there is insufficient knowledge about who these children are. All children and adolescents, who start treatment with ADHD medication at public Child and Adolescent Psychiatry units in Stockholm, on Gotland, an in Västerbotten, will be asked to participate in the study. The investigators intend to monitor the patients´clinical symptoms and possible side-effects after treatment start. The investigators will collect background information and saliva samples from the patient and his/her parents to be able to study if there are any genetic (hereditary) or other markers that can predict positive or negative outcomes of the ADHD medication. With this information, the investigators aim at, to a greater extent, be able to individualize treatment choices for children and adolescents with ADHD without unnecessary, costly and possibly unfavorable treatment attempts.
Read the detailed description
The specific aims for the ADAPT study are:
- Investigate if certain gene polymorphisms are associated with poor effect of ADHD drugs (non-responders).
- Investigate if other biologically, phenotypic or psychosocial factors are associated with poor effect of ADHD drugs (non-responders).
- Investigate if the frequency of side-effects of ADHD drugs differs between children with different genotypes.
- Investigate if the frequency of side-effects of ADHD drugs differs between children with different phenotypic and/or psychosocial factors
Method:
This study has a naturalistic design. The aim is to map all new treatments with ADHD drugs at all 13 public BUP units in Stockholm County, one BUP unit on Gotland, and three BUP units in Västerbotten Region. The participation means that medication is initiated as planned in normal clinical practice by the child´s ordinary physician, and beyond this only means a somewhat denser and more structured follow-up. In addition, the investigators will ask for saliva samples from the patient and his/her parents. The investigators aim at including at least 1000 individuals in total in the study.
Part of the data will be collected via the national Quality Register for ADHD Treatment Follow-up (BUSA), which has approved security procedures approved by the Swedish Data Inspection Board.
Case report forms are computerized and separate from the database registry for collected study data. The database and detailed variable lists are constructed in collaboration with professional database managers.
Standard Operation Procedures are designed in collaboration by project coordinator, study nurse and principal investigator, and may be revised after pilot phase.
Collected samples will be stored at KI biobank.
Data analysis:
- To judge if the patient is a responder to ADHD drugs the SNAP-IV rating of ADHD symptoms (before and after medication start) is used. The patients who at 3 months have an at least 40% reduction in SNAP-IV score are reckoned "responders" and those who at the same time point have a less than 20% change in SNAP-IV score are reckoned "non-responders". Differences between the groups will be analyzed with logistic regression, with responder status as depending variable, and genotype and the other risk markers (biological, phenotypic, and psychosocial markers) as independent variables after correction for symptoms at baseline. Even a 50% drop-out rate will (i.e. 1000 out of estimated 2000 eligible individuals) give a 98% power to identify a 49% increase in non-responder proportion for a specific genotype.
- Concomitantly, the outcome in side-effects, heart rate, blood pressure, weight (z-score) and length (z-score) will be analyzed with linear regression with the same independent variables.
- The analyses are performed separately for each ADHD drug.
- There are significantly more boys than girls (about 4:1) with ADHD. Given the sex difference in prevalence it is obvious to also include sex as a covariate in our analyses of treatment outcome.
- Missing data will be treated according to the principles of complete case and multiple imputation.
- Being tested
- methylphenidate medication, atomoxetine medication, lisdexamphetamine medication, guanfacine medication
- Keywords
- Attention Deficit Disorder with Hyperactivity, Neuropsychiatry, Drug therapy, Pharmacogenetics, Child Psychiatry
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate medicationDrug
Also called N06BA04, Concerta, Ritalin, Equasym
atomoxetine medicationDrug
Also called N06BA09, Strattera
lisdexamphetamine medicationDrug
Also called N06BA12, Elvanse
guanfacine medicationDrug
Also called C02AC02, Intuniv
| Study group | Role | What they receive |
|---|---|---|
| Children with ADHD medication | Identified responders and non-responders in children/adolescents starting medication for treatment of ADHD in public child and adolescent psychiatric services in Stockholm, on Gotland, and in Västerbotten. Receives: Drug: methylphenidate medication; Drug: atomoxetine medication; Drug: lisdexamphetamine medication; Drug: guanfacine medication | |
| Lisdexamphetamine medication | Identified responders and non-responders in children/adolescents starting medication with lisdexamphetamine in public child and adolescent psychiatric services in Stockholm and on Gotland. Receives: Drug: lisdexamphetamine medication | |
| Atomoxetine medication | Identified responders and non-responders in children/adolescents starting medication with atomoxetine in public child and adolescent psychiatric services in Stockholm and on Gotland. Receives: Drug: atomoxetine medication | |
| Methylphenidate medication | Identified responders and non-responders in children/adolescents starting medication with methylphenidate in public child and adolescent psychiatric services in Stockholm and on Gotland. Receives: Drug: methylphenidate medication | |
| Guanfacine medication | Identified responders and non-responders in children/adolescents starting medication with guanfacine in public child and adolescent psychiatric services in Stockholm and on Gotland. Receives: Drug: guanfacine medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in SNAP-IV Teacher and Parent rating scale (Swanson, Nolan and Pelham ADHD Rating Scale)
ADHD symptoms
Measured: at 3 months follow-up
change in P-SEC (Pediatric Side Effects Checklist)
Side-effect measure
Measured: at 3 months follow-up
Secondary outcomes (34)
change in C-GAS (Children´s global assessment scale)
global functioning measure
Measured: at 12 months follow-up
change in CGI-S (Clinical Global Impression- of Severity)
disease severity
Measured: at 12 months follow-up
change in SNAP-IV Teacher and Parent rating scale
ADHD symptoms
Measured: at 1 month follow-up
change in SNAP-IV Teacher and Parent rating scale
ADHD symptoms
Measured: at 6 months follow-up
change in SNAP-IV Teacher and Parent rating scale
ADHD symptoms
Measured: at 12 months follow-up
change in P-SEC (Pediatric Side Effects Checklist)
side effect measure
Measured: at 1 month follow-up
change in P-SEC (Pediatric Side Effects Checklist)
side effect measure
Measured: at 6 months follow-up
change in P-SEC (Pediatric Side Effects Checklist)
side effect measure
Measured: at 12 months follow-up
change in Spence Children's Anxiety Scale (SCAS)
symptoms of anxiety
Measured: at 1 month follow-up
change in Spence Children's Anxiety Scale (SCAS)
symptoms of anxiety
Measured: at 3 months follow-up
change in Spence Children's Anxiety Scale (SCAS)
symptoms of anxiety
Measured: at 6 months follow-up
change in Spence Children's Anxiety Scale (SCAS)
symptoms of anxiety
Measured: at 12 months follow-up
change in heart rate
Measured: at 1 month follow-up
change in heart rate
Measured: at 3 months follow-up
change in heart rate
Measured: at 6 months follow-up
change in heart rate
Measured: at 12 months follow-up
change in systolic blood pressure
Measured: at 1 month follow-up
change in systolic blood pressure
Measured: at 3 months follow-up
change in systolic blood pressure
Measured: at 6 months follow-up
change in systolic blood pressure
Measured: at 12 months follow-up
change in diastolic blood pressure
Measured: at 1 month follow-up
change in diastolic blood pressure
Measured: at 3 months follow-up
change in diastolic blood pressure
Measured: at 6 months follow-up
change in diastolic blood pressure
Measured: at 12 months follow-up
change in weight z-score
Measured: at 1 month follow-up
change in weight z-score
Measured: at 3 months follow-up
change in weight z-score
Measured: at 6 months follow-up
change in weight z-score
Measured: at 12 months follow-up
change in height z-score
Measured: at 6 months follow-up
change in height z-score
Measured: at 12 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
symptoms of autism
Measured: at 3 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
symptoms of autism
Measured: at 1 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
symptoms of autism
Measured: at 6 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
symptoms of autism
Measured: at 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJun 2015
- Primary completionJul 2021
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 632 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Halldner Henriksson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136147
- Sponsor's protocol ID
- ADAPT
- Other IDs
- LS 1110-1339, SLS-309701
- Acronym
- ADAPT
- Status last verified
- Oct 2023
- First submitted
- 30 Apr 2014
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lilja MM, Lichtenstein P, Serlachius E, Bhagia J, Malmberg K, Malm C, Lenhard F, Halldner L. Can response to ADHD medication be predicted? Eur Child Adolesc Psychiatry. 2025 Aug;34(8):2431-2442. doi: 10.1007/s00787-025-02650-8. Epub 2025 Jan 29.
PubMed 39875602Lilja MM, Sandblom E, Lichtenstein P, Serlachius E, Hellner C, Bhagia J, Halldner L. The effect of autistic traits on response to and side-effects of pharmacological ADHD treatment in children with ADHD: results from a prospective clinical cohort. J Neurodev Disord. 2022 Mar 6;14(1):17. doi: 10.1186/s11689-022-09424-2.
PubMed 35249540
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Study of ADHD Medication and Predictors of Treatment Outcome
- ClinicalTrials.gov ID
- NCT02136147
- Acronym / sponsor ID
- ADAPT / ADAPT
- Keywords
- Attention Deficit Disorder with Hyperactivity, Neuropsychiatry, Drug therapy, Pharmacogenetics, Child Psychiatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 12 May 2014 (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.
ADHD medication of children and adolescents is becoming increasingly common. Clinical experience and scientific studies have proven that approximately 30% of children/adolescents with ADHD do not benefit from this treatment. However, there is insufficient knowledge about who these children are. All children and adolescents, who start treatment with ADHD medication at public Child and Adolescent Psychiatry units in Stockholm, on Gotland, an in Västerbotten, will be asked to participate in the study. The investigators intend to monitor the patients´clinical symptoms and possible side-effects after treatment start. The investigators will collect background information and saliva samples from the patient and his/her parents to be able to study if there are any genetic (hereditary) or other markers that can predict positive or negative outcomes of the ADHD medication. With this information, the investigators aim at, to a greater extent, be able to individualize treatment choices for children and adolescents with ADHD without unnecessary, costly and possibly unfavorable treatment attempts.
Detailed description
The specific aims for the ADAPT study are:
- Investigate if certain gene polymorphisms are associated with poor effect of ADHD drugs (non-responders).
- Investigate if other biologically, phenotypic or psychosocial factors are associated with poor effect of ADHD drugs (non-responders).
- Investigate if the frequency of side-effects of ADHD drugs differs between children with different genotypes.
- Investigate if the frequency of side-effects of ADHD drugs differs between children with different phenotypic and/or psychosocial factors
Method:
This study has a naturalistic design. The aim is to map all new treatments with ADHD drugs at all 13 public BUP units in Stockholm County, one BUP unit on Gotland, and three BUP units in Västerbotten Region. The participation means that medication is initiated as planned in normal clinical practice by the child´s ordinary physician, and beyond this only means a somewhat denser and more structured follow-up. In addition, the investigators will ask for saliva samples from the patient and his/her parents. The investigators aim at including at least 1000 individuals in total in the study.
Part of the data will be collected via the national Quality Register for ADHD Treatment Follow-up (BUSA), which has approved security procedures approved by the Swedish Data Inspection Board.
Case report forms are computerized and separate from the database registry for collected study data. The database and detailed variable lists are constructed in collaboration with professional database managers.
Standard Operation Procedures are designed in collaboration by project coordinator, study nurse and principal investigator, and may be revised after pilot phase.
Collected samples will be stored at KI biobank.
Data analysis:
- To judge if the patient is a responder to ADHD drugs the SNAP-IV rating of ADHD symptoms (before and after medication start) is used. The patients who at 3 months have an at least 40% reduction in SNAP-IV score are reckoned "responders" and those who at the same time point have a less than 20% change in SNAP-IV score are reckoned "non-responders". Differences between the groups will be analyzed with logistic regression, with responder status as depending variable, and genotype and the other risk markers (biological, phenotypic, and psychosocial markers) as independent variables after correction for symptoms at baseline. Even a 50% drop-out rate will (i.e. 1000 out of estimated 2000 eligible individuals) give a 98% power to identify a 49% increase in non-responder proportion for a specific genotype.
- Concomitantly, the outcome in side-effects, heart rate, blood pressure, weight (z-score) and length (z-score) will be analyzed with linear regression with the same independent variables.
- The analyses are performed separately for each ADHD drug.
- There are significantly more boys than girls (about 4:1) with ADHD. Given the sex difference in prevalence it is obvious to also include sex as a covariate in our analyses of treatment outcome.
- Missing data will be treated according to the principles of complete case and multiple imputation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Children with ADHD medication | – | Drug: methylphenidate medication, Drug: atomoxetine medication, Drug: lisdexamphetamine medication, Drug: guanfacine medicationIdentified responders and non-responders in children/adolescents starting medication for treatment of ADHD in public child and adolescent psychiatric services in Stockholm, on Gotland, and in Västerbotten. |
| Lisdexamphetamine medication | – | Drug: lisdexamphetamine medicationIdentified responders and non-responders in children/adolescents starting medication with lisdexamphetamine in public child and adolescent psychiatric services in Stockholm and on Gotland. |
| Atomoxetine medication | – | Drug: atomoxetine medicationIdentified responders and non-responders in children/adolescents starting medication with atomoxetine in public child and adolescent psychiatric services in Stockholm and on Gotland. |
| Methylphenidate medication | – | Drug: methylphenidate medicationIdentified responders and non-responders in children/adolescents starting medication with methylphenidate in public child and adolescent psychiatric services in Stockholm and on Gotland. |
| Guanfacine medication | – | Drug: guanfacine medicationIdentified responders and non-responders in children/adolescents starting medication with guanfacine in public child and adolescent psychiatric services in Stockholm and on Gotland. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children/adolescents starting ADHD medication at the public child and adolescent psychiatry services in Stockholm and on Gotland
Key inclusion criteria (3 listed)
- Clinical diagnosis of ADHD
- Starting medication against ADHD symptoms with atomoxetine, methylphenidate, lisdexamphetamine, or guanfacine
- Exclusion Criteria: Any medication against ADHD the last 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| methylphenidate medicationAlso: N06BA04, Concerta, Ritalin, Equasym | Drug | Children with ADHD medication, Methylphenidate medication |
| atomoxetine medicationAlso: N06BA09, Strattera | Drug | Atomoxetine medication, Children with ADHD medication |
| lisdexamphetamine medicationAlso: N06BA12, Elvanse | Drug | Children with ADHD medication, Lisdexamphetamine medication |
| guanfacine medicationAlso: C02AC02, Intuniv | Drug | Children with ADHD medication, Guanfacine medication |
Primary outcome
change in SNAP-IV Teacher and Parent rating scale (Swanson, Nolan and Pelham ADHD Rating Scale)
Time frame: at 3 months follow-up
ADHD symptoms
change in P-SEC (Pediatric Side Effects Checklist)
Time frame: at 3 months follow-up
Side-effect measure
34 secondary outcomes
change in C-GAS (Children´s global assessment scale)
Time frame: at 12 months follow-up
change in CGI-S (Clinical Global Impression- of Severity)
Time frame: at 12 months follow-up
change in SNAP-IV Teacher and Parent rating scale
Time frame: at 1 month follow-up
change in SNAP-IV Teacher and Parent rating scale
Time frame: at 6 months follow-up
change in SNAP-IV Teacher and Parent rating scale
Time frame: at 12 months follow-up
change in P-SEC (Pediatric Side Effects Checklist)
Time frame: at 1 month follow-up
change in P-SEC (Pediatric Side Effects Checklist)
Time frame: at 6 months follow-up
change in P-SEC (Pediatric Side Effects Checklist)
Time frame: at 12 months follow-up
change in Spence Children's Anxiety Scale (SCAS)
Time frame: at 1 month follow-up
change in Spence Children's Anxiety Scale (SCAS)
Time frame: at 3 months follow-up
change in Spence Children's Anxiety Scale (SCAS)
Time frame: at 6 months follow-up
change in Spence Children's Anxiety Scale (SCAS)
Time frame: at 12 months follow-up
change in heart rate
Time frame: at 1 month follow-up
change in heart rate
Time frame: at 3 months follow-up
change in heart rate
Time frame: at 6 months follow-up
change in heart rate
Time frame: at 12 months follow-up
change in systolic blood pressure
Time frame: at 1 month follow-up
change in systolic blood pressure
Time frame: at 3 months follow-up
change in systolic blood pressure
Time frame: at 6 months follow-up
change in systolic blood pressure
Time frame: at 12 months follow-up
change in diastolic blood pressure
Time frame: at 1 month follow-up
change in diastolic blood pressure
Time frame: at 3 months follow-up
change in diastolic blood pressure
Time frame: at 6 months follow-up
change in diastolic blood pressure
Time frame: at 12 months follow-up
change in weight z-score
Time frame: at 1 month follow-up
change in weight z-score
Time frame: at 3 months follow-up
change in weight z-score
Time frame: at 6 months follow-up
change in weight z-score
Time frame: at 12 months follow-up
change in height z-score
Time frame: at 6 months follow-up
change in height z-score
Time frame: at 12 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
Time frame: at 3 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
Time frame: at 1 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
Time frame: at 6 months follow-up
change in Autism Spectrum Screening Questionnaire (ASSQ) score
Time frame: at 12 months follow-up
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 17 Oct 2023.
- Derived from this study: PubMed 39875602Lilja MM, Lichtenstein P, Serlachius E, Bhagia J, Malmberg K, Malm C, Lenhard F, Halldner L. Can response to ADHD medication be predicted? Eur Child Adolesc Psychiatry. 2025 Aug;34(8):2431-2442. doi: 10.1007/s00787-025-02650-8. Epub 2025 Jan 29.
- Derived from this study: PubMed 35249540Lilja MM, Sandblom E, Lichtenstein P, Serlachius E, Hellner C, Bhagia J, Halldner L. The effect of autistic traits on response to and side-effects of pharmacological ADHD treatment in children with ADHD: results from a prospective clinical cohort. J Neurodev Disord. 2022 Mar 6;14(1):17. doi: 10.1186/s11689-022-09424-2.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity (ADHD), run by Karolinska Institutet at 1 site in Sweden.
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 0 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 17 Oct 2023. 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 Sweden. 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?
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 SNAP-IV Teacher and Parent rating scale (Swanson, Nolan and Pelham ADHD Rating Scale) (time frame: at 3 months follow-up). 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 NCT02136147, which also lists 2 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 17 Oct 2023.