Attention Deficit Hyperactivity DisorderNCT03203928
Effectiveness of a Tailored Occupational Therapy Intervention for Women With ADHD
A study testing Occupational Therapy Intervention for Women with ADHD in people with Attention Deficit Hyperactivity Disorder, run by Columbia University at 1 site in United States.
Trial summary
Although woman are diagnosed with Attention-deficit hyperactivity disorder (ADHD) at a 1:3 ratio with men, recent research suggests that woman may experience the same levels of adult ADHD as men but are underdiagnosed because symptoms may be less severe and/or mistaken for anxiety and depression. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Occupational Therapy Intervention for Women with ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 10 Jan 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 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 21-55 years
- English-speaking
- Self-reported ADHD
Who cannot join
- Severe co-morbid condition such as an eating disorder, major depression, bipolar disorder, schizophrenia spectrum disorder, or substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Effectiveness of a Tailored Occupational Therapy Intervention for Women With Attention-Deficit/Hyperactivity Disorder (ADHD)
Although woman are diagnosed with Attention-deficit hyperactivity disorder (ADHD) at a 1:3 ratio with men, recent research suggests that woman may experience the same levels of adult ADHD as men but are underdiagnosed because symptoms may be less severe and/or mistaken for anxiety and depression. Women with ADHD typically experience problems in managing worker, student, spousal, and parenting roles dues to disorganization, poor time management, difficulty regulating internal and external stressors, and difficulty maintaining daily schedules and routines. Intervention effectiveness research has largely focused on pharmacological treatment of ADHD symptoms; however, while such pharmacological treatment tends to enhance concentration and reduce motor restlessness, it does not address the skills needed to successfully carry out daily life roles and activities dependent upon time management, prioritization of tasks, and regulation of emotional responses within the home, school/work, and community environments. In this study, the investigators aim to determine whether a 7-week tailored occupational therapy intervention addressing organization, time management, stress management, and sensory regulation in the home, school/work, and community environments can increase satisfaction in desired daily life activities, and reduce ADHD symptoms and stress levels in women with ADHD.
Read the detailed description
Attention-deficit hyperactivity disorder (ADHD) is believed to be neurologically based and characterized by enduring attentional problems, motor restlessness, and cognitive and motor impulsivity that impact one's ability to function optimally in daily life activities. ADHD is commonly diagnosed in childhood at a prevalence rate of 11% and a male to female ratio of 3:1. The prevalence of adult ADHD varies from 4 to 6% and it is estimated that two-thirds of adult ADHD disorders are extensions of childhood ADHD. Researchers have suggested that the male to female prevalence ratio is inaccurate and that females experience ADHD at similar levels to males but are underdiagnosed. While boys with ADHD are often identified by their teachers because of motor impulsivity and inattention, girls with ADHD who may experience attentional problems and impulsivity without significant hyperactivity, may fail to be identified by teachers as needing evaluation and treatment. Some studies have found that female children and adolescents who experience the ADHD symptoms of inattention, disorganization, poor time management, and distractibility are more likely to be misdiagnosed with depression and anxiety. When depression and anxiety occur in children and adolescents with undiagnosed ADHD symptoms, they may result from the inability to manage ADHD symptoms as they impact functional performance in the home, school, and community.
Much of the research exploring ADHD has been devoted to children and adolescents. The research examining adult ADHD has thus far largely attempted to describe the phenomenon of adult ADHD. Research investigating intervention effectiveness for adult ADHD has primarily focused on pharmacological treatment. The small body of research examining non-pharmacological treatment has found moderate effectiveness for pharmacological intervention combined with cognitive behavioral therapy and psychoeducation.
Missing from this body of literature is research specifically examining interventions for women with ADHD, who present symptoms that are both overlapping with and unique from their male counterparts.
Studies have found that women with ADHD tend to have difficulty maintaining and succeeding in employment, school, and parenting and spousal roles. The ability to organize and implement tasks associated with each role, follow daily schedules and routines needed to support desired roles, prioritize and manage tasks in a timely manner, and regulate internal and external stressors to maintain consistent emotional responses may be difficult for with women with ADHD.
In this study, the investigators aim to provide a 7-week tailored intervention for women with ADHD who have difficulty carrying out student, worker, spousal, and parenting roles due to poor time management, organization of their physical environments, management of internal and external stressors, and regulation of internal and external stimulation.
This intervention effectiveness study will use randomization and control. Twenty-four women who self-report diagnoses of ADHD will be recruited to participate and randomly assigned to either the intervention group (n=12) or control group (n=12). The intervention group will receive the 6-week intervention; the control group will not receive intervention (bit will receive an organization toolkit at study end).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Occupational Therapy Intervention for Women with ADHD
- Keywords
- ADHD, Occupational Therapy
- 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.
Occupational Therapy Intervention for Women with ADHDBehavioural
The intervention will run for 7 weeks and consist of the following 1-hour sessions. Each intervention session will be facilitated by two CUMC occupational therapy students in each participant's home environment (or another environment of the participant's choosing such as the work or school environment).
Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy for Women with ADHD | Experimental | 7-week tailored intervention for women with ADHD who have difficulty carrying out student, worker, spousal, and parenting roles due to poor time management, organization of their physical environments, management of internal and external stressors, and regulation of internal and external stimulation. Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments. Receives: Behavioral: Occupational Therapy Intervention for Women with ADHD |
| Control | No intervention | No treatment provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Score on World Health Organization Adult ADHD Self-Report Scale between pre- and post-intervention
18-item, 5-point Likert scale that requires 5 minutes to complete
Measured: baseline and 8 weeks
Secondary outcomes (2)
Difference in Score on Perceived Stress Scale between pre- and post-intervention
10-item, 5-point, self-report Likert scale that requires 5 minutes to complete
Measured: baseline and 8 weeks
Difference in Score on Canadian Occupational Performance Measure
5-item, 10-point rating scale designed to be completed conjointly by a therapist and participant and takes approximately 10 minutes to complete
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start15 Sep 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Model description
- Two group randomized controlled study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Gutman, Columbia University
- Investigators
- Sharon Gutman, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203928
- Sponsor's protocol ID
- AAAR4416
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Psychiatric Association. (2013). Diagnostic and statistical manual of mentaldisorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
Centers for Disease Control and Prevention. (2017). Attention-deficit/hyperactivity disorder (ADHD). Retrieved from https://www.cdc.gov/ncbddd/adhd/data.html
Vande Voort JL, He JP, Jameson ND, Merikangas KR. Impact of the DSM-5 attention-deficit/hyperactivity disorder age-of-onset criterion in the US adolescent population. J Am Acad Child Adolesc Psychiatry. 2014 Jul;53(7):736-44. doi: 10.1016/j.jaac.2014.03.005. Epub 2014 Apr 23.
PubMed 24954823Jaconis M, Boyd SJ, Hartung CM, McCrea SM, Lefler EK, Canu WH. Sex differences in claimed and behavioral self-handicapping and ADHD symptomatology in emerging adults. Atten Defic Hyperact Disord. 2016 Dec;8(4):205-214. doi: 10.1007/s12402-016-0200-y. Epub 2016 Jun 21.
PubMed 27329539Coles EK, Slavec J, Bernstein M, Baroni E. Exploring the gender gap in referrals for children with ADHD and other disruptive behavior disorders. J Atten Disord. 2012 Feb;16(2):101-8. doi: 10.1177/1087054710381481. Epub 2010 Sep 13.
PubMed 20837979Quinn PO, Madhoo M. A review of attention-deficit/hyperactivity disorder in women and girls: uncovering this hidden diagnosis. Prim Care Companion CNS Disord. 2014;16(3):PCC.13r01596. doi: 10.4088/PCC.13r01596. Epub 2014 Oct 13.
PubMed 25317366Fredriksen M, Dahl AA, Martinsen EW, Klungsoyr O, Faraone SV, Peleikis DE. Childhood and persistent ADHD symptoms associated with educational failure and long-term occupational disability in adult ADHD. Atten Defic Hyperact Disord. 2014 Jun;6(2):87-99. doi: 10.1007/s12402-014-0126-1. Epub 2014 Feb 5.
PubMed 24497125Biederman J, Fried R, Tarko L, Surman C, Spencer T, Pope A, Grossman R, McDermott K, Woodworth KY, Faraone SV. Memantine in the Treatment of Executive Function Deficits in Adults With ADHD. J Atten Disord. 2017 Feb;21(4):343-352. doi: 10.1177/1087054714538656. Epub 2016 Jul 28.
PubMed 24970718Philipsen A, Jans T, Graf E, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Gross-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Burger A, Perlov E, Ihorst G, Schlander M, Berger M, Tebartz van Elst L; Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium. Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1199-210. doi: 10.1001/jamapsychiatry.2015.2146.
PubMed 26536057Fuller-Thomson E, Lewis DA, Agbeyaka SK. Attention-deficit/hyperactivity disorder casts a long shadow: findings from a population-based study of adult women with self-reported ADHD. Child Care Health Dev. 2016 Nov;42(6):918-927. doi: 10.1111/cch.12380. Epub 2016 Jul 20.
PubMed 27439337
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Tailored Occupational Therapy Intervention for Women With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT03203928
- Acronym / sponsor ID
- AAAR4416
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- 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.
Although woman are diagnosed with Attention-deficit hyperactivity disorder (ADHD) at a 1:3 ratio with men, recent research suggests that woman may experience the same levels of adult ADHD as men but are underdiagnosed because symptoms may be less severe and/or mistaken for anxiety and depression. Women with ADHD typically experience problems in managing worker, student, spousal, and parenting roles dues to disorganization, poor time management, difficulty regulating internal and external stressors, and difficulty maintaining daily schedules and routines. Intervention effectiveness research has largely focused on pharmacological treatment of ADHD symptoms; however, while such pharmacological treatment tends to enhance concentration and reduce motor restlessness, it does not address the skills needed to successfully carry out daily life roles and activities dependent upon time management, prioritization of tasks, and regulation of emotional responses within the home, school/work, and community environments. In this study, the investigators aim to determine whether a 7-week tailored occupational therapy intervention addressing organization, time management, stress management, and sensory regulation in the home, school/work, and community environments can increase satisfaction in desired daily life activities, and reduce ADHD symptoms and stress levels in women with ADHD.
Detailed description
Attention-deficit hyperactivity disorder (ADHD) is believed to be neurologically based and characterized by enduring attentional problems, motor restlessness, and cognitive and motor impulsivity that impact one's ability to function optimally in daily life activities. ADHD is commonly diagnosed in childhood at a prevalence rate of 11% and a male to female ratio of 3:1. The prevalence of adult ADHD varies from 4 to 6% and it is estimated that two-thirds of adult ADHD disorders are extensions of childhood ADHD. Researchers have suggested that the male to female prevalence ratio is inaccurate and that females experience ADHD at similar levels to males but are underdiagnosed. While boys with ADHD are often identified by their teachers because of motor impulsivity and inattention, girls with ADHD who may experience attentional problems and impulsivity without significant hyperactivity, may fail to be identified by teachers as needing evaluation and treatment. Some studies have found that female children and adolescents who experience the ADHD symptoms of inattention, disorganization, poor time management, and distractibility are more likely to be misdiagnosed with depression and anxiety. When depression and anxiety occur in children and adolescents with undiagnosed ADHD symptoms, they may result from the inability to manage ADHD symptoms as they impact functional performance in the home, school, and community.
Much of the research exploring ADHD has been devoted to children and adolescents. The research examining adult ADHD has thus far largely attempted to describe the phenomenon of adult ADHD. Research investigating intervention effectiveness for adult ADHD has primarily focused on pharmacological treatment. The small body of research examining non-pharmacological treatment has found moderate effectiveness for pharmacological intervention combined with cognitive behavioral therapy and psychoeducation.
Missing from this body of literature is research specifically examining interventions for women with ADHD, who present symptoms that are both overlapping with and unique from their male counterparts.
Studies have found that women with ADHD tend to have difficulty maintaining and succeeding in employment, school, and parenting and spousal roles. The ability to organize and implement tasks associated with each role, follow daily schedules and routines needed to support desired roles, prioritize and manage tasks in a timely manner, and regulate internal and external stressors to maintain consistent emotional responses may be difficult for with women with ADHD.
In this study, the investigators aim to provide a 7-week tailored intervention for women with ADHD who have difficulty carrying out student, worker, spousal, and parenting roles due to poor time management, organization of their physical environments, management of internal and external stressors, and regulation of internal and external stimulation.
This intervention effectiveness study will use randomization and control. Twenty-four women who self-report diagnoses of ADHD will be recruited to participate and randomly assigned to either the intervention group (n=12) or control group (n=12). The intervention group will receive the 6-week intervention; the control group will not receive intervention (bit will receive an organization toolkit at study end).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy for Women with ADHD | Experimental | Behavioral: Occupational Therapy Intervention for Women with ADHD7-week tailored intervention for women with ADHD who have difficulty carrying out student, worker, spousal, and parenting roles due to poor time management, organization of their physical environments, management of internal and external stressors, and regulation of internal and external stimulation. Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments. |
| Control | No intervention | –No treatment provided. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females aged 21-55 years
- English-speaking
- Self-reported ADHD
Key exclusion criteria (1 listed)
- Severe co-morbid condition such as an eating disorder, major depression, bipolar disorder, schizophrenia spectrum disorder, or substance use 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 |
|---|---|---|
| Occupational Therapy Intervention for Women with ADHDThe intervention will run for 7 weeks and consist of the following 1-hour sessions. Each intervention session will be facilitated by two CUMC occupational therapy students in each participant's home environment (or another environment of the participant's choosing such as the work or school environment). Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments. | Behavioural | Occupational Therapy for Women with ADHD |
Primary outcome
Difference in Score on World Health Organization Adult ADHD Self-Report Scale between pre- and post-intervention
Time frame: baseline and 8 weeks
18-item, 5-point Likert scale that requires 5 minutes to complete
2 secondary outcomes
Difference in Score on Perceived Stress Scale between pre- and post-intervention
Time frame: baseline and 8 weeks
Difference in Score on Canadian Occupational Performance Measure
Time frame: baseline and 8 weeks
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 Jul 2018.
- BackgroundAmerican Psychiatric Association. (2013). Diagnostic and statistical manual of mentaldisorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
- BackgroundCenters for Disease Control and Prevention. (2017). Attention-deficit/hyperactivity disorder (ADHD). Retrieved from https://www.cdc.gov/ncbddd/adhd/data.html
- Background: PubMed 24954823Vande Voort JL, He JP, Jameson ND, Merikangas KR. Impact of the DSM-5 attention-deficit/hyperactivity disorder age-of-onset criterion in the US adolescent population. J Am Acad Child Adolesc Psychiatry. 2014 Jul;53(7):736-44. doi: 10.1016/j.jaac.2014.03.005. Epub 2014 Apr 23.
- Background: PubMed 27329539Jaconis M, Boyd SJ, Hartung CM, McCrea SM, Lefler EK, Canu WH. Sex differences in claimed and behavioral self-handicapping and ADHD symptomatology in emerging adults. Atten Defic Hyperact Disord. 2016 Dec;8(4):205-214. doi: 10.1007/s12402-016-0200-y. Epub 2016 Jun 21.
- Background: PubMed 20837979Coles EK, Slavec J, Bernstein M, Baroni E. Exploring the gender gap in referrals for children with ADHD and other disruptive behavior disorders. J Atten Disord. 2012 Feb;16(2):101-8. doi: 10.1177/1087054710381481. Epub 2010 Sep 13.
- Background: PubMed 25317366Quinn PO, Madhoo M. A review of attention-deficit/hyperactivity disorder in women and girls: uncovering this hidden diagnosis. Prim Care Companion CNS Disord. 2014;16(3):PCC.13r01596. doi: 10.4088/PCC.13r01596. Epub 2014 Oct 13.
- Background: PubMed 24497125Fredriksen M, Dahl AA, Martinsen EW, Klungsoyr O, Faraone SV, Peleikis DE. Childhood and persistent ADHD symptoms associated with educational failure and long-term occupational disability in adult ADHD. Atten Defic Hyperact Disord. 2014 Jun;6(2):87-99. doi: 10.1007/s12402-014-0126-1. Epub 2014 Feb 5.
- Background: PubMed 24970718Biederman J, Fried R, Tarko L, Surman C, Spencer T, Pope A, Grossman R, McDermott K, Woodworth KY, Faraone SV. Memantine in the Treatment of Executive Function Deficits in Adults With ADHD. J Atten Disord. 2017 Feb;21(4):343-352. doi: 10.1177/1087054714538656. Epub 2016 Jul 28.
- Background: PubMed 26536057Philipsen A, Jans T, Graf E, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Gross-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Burger A, Perlov E, Ihorst G, Schlander M, Berger M, Tebartz van Elst L; Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium. Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1199-210. doi: 10.1001/jamapsychiatry.2015.2146.
- Background: PubMed 27439337Fuller-Thomson E, Lewis DA, Agbeyaka SK. Attention-deficit/hyperactivity disorder casts a long shadow: findings from a population-based study of adult women with self-reported ADHD. Child Care Health Dev. 2016 Nov;42(6):918-927. doi: 10.1111/cch.12380. Epub 2016 Jul 20.
- 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.
Sharon Gutman, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy Intervention for Women with ADHD in people with Attention Deficit Hyperactivity Disorder, run by Columbia University 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 1 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 Jul 2018. 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?
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?
Difference in Score on World Health Organization Adult ADHD Self-Report Scale between pre- and post-intervention (time frame: baseline and 8 weeks). 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 NCT03203928, which also lists 10 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 Jul 2018.