Feeding and Eating DisordersNCT03684239
The Effect of G-CBT on the Patients With AN
A study testing G-CBT and Conventional treatment in people with Feeding and Eating Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The study is to examine whether the G-CBT for anorexia nervosa is effective or not. The study will use randomized controlled study design. 80 patients with AN will be recruited from Shanghai Mental Health Center, There will be two groups: CBT treatment group and conventional treatment group. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Feeding and Eating Disorders
- What is being tested?
- G-CBT and Conventional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Dec 2020
- 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 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 14-30 years;
- right handedness;
- above primary education;
- met DSM-V criteria for AN
Who cannot join
- diagnosed with a mental illness;
- with severe physical or cognitive impairment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jue Chen, Ph.D, 021-34773549, chenjue2088@163.com
Yunling Zou, 8613621796576, flattop1989@qq.com
About this study
Official title: The Effect of G-CBT on the Patients With AN : A Randomized Controlled Trial
The study is to examine whether the G-CBT for anorexia nervosa is effective or not. The study will use randomized controlled study design. 80 patients with AN will be recruited from Shanghai Mental Health Center, There will be two groups: CBT treatment group and conventional treatment group. Each group is 40 and then the CBT group will be given standard CBT intervention for 12 weeks. The control group will receive outpatient treatment. To assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales, psychological scales and the security indexs will be used at baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up).
Read the detailed description
Eating disorder is a chronic mental disorder characteristic of abnormal eating behaviors and psychological disorders, accompanied by significant weight changes and physiological dysfunction. Many people with EDs have cognitive disorder of their body shape or body weight. Anorexia is a subtype of EDs. The main feature of anorexia nervosa is the extreme attention to body weight and body shape. As a result of this conflict the patients could be malnutrition, metabolism and endocrine disorders with significant weight loss. And women may have amenorrhea. At the mean time, the patient will also have a lot of mental symptoms such as depression, anxiety and obsession.
The disease mostly occurs in adolescents and young women. The prevalence rates in Europe and America is 0.5%-3.7%, 90% of which are women. The course of the disease is chronic, the average duration of disease is 4-6 years. Furthermore the mortality rate is high, a 20-year follow-up data shows that the mortality rate is nearly 20%. Most of the causes of death are physical complications and depression.
However, due to the special psychological behavior mechanism, patients have almost no willingness to be treated. As well as the long duration of disease and the highrisk of drug therapy, it all causes the great difficulties in the treatment. Many patients may even suffer from eating disorders for a lifetime. On another hand, the effective treatment options are still inconclusive. Psychotherapy, especially and cognitive behavior, is one of the most effective treatments at present.
On the other hand, psychotherapy is quite expensive, requiring not only a large number of qualified therapists, but also a long treatment time. Which leads to a high treatment cost. In order to reduce the cost of treatment, group therapy is a reasonable choice. However, currently there are no related research reports in china.
Our study is to examine whether the G-CBT for anorexia nervosa is effective or not. The study will use randomized controlled study design. 80 patients with AN will be recruited from Shanghai Mental Health Center, There will be two groups: CBT treatment group and conventional treatment group. Each group is 40 and then the CBT group will be given standard CBT intervention for 12 weeks. The control group will receive outpatient treatment. To assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales, psychological scales and the security indexs will be used at baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up).
This study was designed with sufficient consideration about innovation as well as feasibility, and is to be operated on well proved theoretical basis and guidance of an operation manual. If successful, results of this study may bring great improvement to clinical practice of this refractory mental disorder.
- Conditions
- Feeding and Eating Disorders
- Being tested
- G-CBT, Conventional treatment
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CBTBehavioural
CBT is based on the model that there is a interaction between cognition, emotion and behavior. The way people think affects the way they feel and the behavior they do. And then the feelings in turn affect how they think,So it is valid for AN patient.
Conventional treatmentOther
Conventional treatment including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders.
| Study group | Role | What they receive |
|---|---|---|
| G-CBT group | Experimental | G-CBT group has 40 patients, maybe will be divided them into 4 groups. Every group has 8-10 patients. Every group receive 10 times CBT group therapy and 1 times a week for 120 minutes each time. Receives: Behavioral: G-CBT; Other: Conventional treatment |
| Conventional treatment group | Active comparator | Conventional treatment group has 40 patients, received routine outpatient treatment. Once every two weeks for 45 minutes each time, including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire(EDE-Q)
Eating Disorder Examination Questionnaire can evaluate the eating disorder behavior and psychology characteristics and assess their frequency and intensity, which can assess the severity of eating disorders.It is a 41 item self-report questionnaire. It retains the format of the EDE including the 4 subscales (1. Restraint; 2. Eating concern; 3. Shape concern; 4. Weight concern) and global score. It also concerns behaviors over a 28-day time period and retains the scoring system of 0-6, with 0 indicating no days, 1=1-5 days, 2=6-12 days, 3=13-15 days, 4=16-22 days, 5=23-27 days and 6= every day.The scoring method is the sum of the scores for each item divided by the number of items.
Measured: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Secondary outcomes (3)
Eating Disorder Inventory(EDI)
EDI can assess the eating attitudes and behaviors. It can evaluate the pathologic psychological characteristics of AN patients.comprises 64 questions, divided into eight subscales. Each question is on a 6-point scale (ranging from 'always' to 'never'), rated 0-3. The score for each sub-scale is then summed. There are 8 subscale scores on the EDI
Measured: Change from Baseline eating attitudes and behaviors at 12weeks,24weeks,36weeks.
Beck Depression Inventory（BDI-II）
Measurement of the severity of the symptoms of depression. It is consisted of twenty-one questions about how the subject has been feeling in the last week. Each question had a set of at least four possible responses, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.
Measured: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Beck Anxiety Inventory（BAI）
Measurement of the severity of the symptoms of anxiety.The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms
Measured: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Feeding and Eating DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue CHEN, Shanghai Mental Health Center
- Investigators
- Jue Chen, PHD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684239
- Sponsor's protocol ID
- 16411965200
- Status last verified
- Dec 2019
- First submitted
- 23 Sep 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and baseline characteristics of participants
Publications
Wonderlich S, Mitchell JE, Crosby RD, Myers TC, Kadlec K, Lahaise K, Swan-Kremeier L, Dokken J, Lange M, Dinkel J, Jorgensen M, Schander L. Minimizing and treating chronicity in the eating disorders: a clinical overview. Int J Eat Disord. 2012 May;45(4):467-75. doi: 10.1002/eat.20978. Epub 2012 Jan 23.
PubMed 22271525Groff SE. Is enhanced cognitive behavioral therapy an effective intervention in eating disorders? A review. J Evid Inf Soc Work. 2015;12(3):272-88. doi: 10.1080/15433714.2013.835756. Epub 2015 Jan 30.
PubMed 25661898Brown TA, Keel PK. Current and emerging directions in the treatment of eating disorders. Subst Abuse. 2012;6:33-61. doi: 10.4137/SART.S7864. Epub 2012 Mar 29.
PubMed 22879753Costa MB, Melnik T. Effectiveness of psychosocial interventions in eating disorders: an overview of Cochrane systematic reviews. Einstein (Sao Paulo). 2016 Apr-Jun;14(2):235-77. doi: 10.1590/S1679-45082016RW3120.
PubMed 27462898de Zwaan M, Hilbert A, Swan-Kremeier L, Simonich H, Lancaster K, Howell LM, Monson T, Crosby RD, Mitchell JE. Comprehensive interview assessment of eating behavior 18-35 months after gastric bypass surgery for morbid obesity. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):79-85. doi: 10.1016/j.soard.2009.08.011. Epub 2009 Sep 3.
PubMed 19837012Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Palmer RL, Dalle Grave R. Enhanced cognitive behaviour therapy for adults with anorexia nervosa: a UK-Italy study. Behav Res Ther. 2013 Jan;51(1):R2-8. doi: 10.1016/j.brat.2012.09.010. Epub 2012 Oct 22.
PubMed 23084515Watson HJ, Allen K, Fursland A, Byrne SM, Nathan PR. Does enhanced cognitive behaviour therapy for eating disorders improve quality of life? Eur Eat Disord Rev. 2012 Sep;20(5):393-9. doi: 10.1002/erv.2186. Epub 2012 Jun 22.
PubMed 22730260Dalle Grave R, El Ghoch M, Sartirana M, Calugi S. Cognitive Behavioral Therapy for Anorexia Nervosa: An Update. Curr Psychiatry Rep. 2016 Jan;18(1):2. doi: 10.1007/s11920-015-0643-4.
PubMed 26689208Polnay A, James VA, Hodges L, Murray GD, Munro C, Lawrie SM. Group therapy for people with bulimia nervosa: systematic review and meta-analysis. Psychol Med. 2014 Aug;44(11):2241-54. doi: 10.1017/S0033291713002791. Epub 2013 Nov 15.
PubMed 24238470Gu L, Zou Y, Huang Y, Liu Q, Chen H, Chen J. The effect of group cognitive behavior therapy on Chinese patients with anorexia nervosa: an open label trial. J Eat Disord. 2021 Sep 15;9(1):114. doi: 10.1186/s40337-021-00469-7.
PubMed 34526151
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of G-CBT on the Patients With AN : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03684239
- Acronym / sponsor ID
- 16411965200
- Conditions
- Feeding and Eating Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 25 Sep 2018 (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.
The study is to examine whether the G-CBT for anorexia nervosa is effective or not. The study will use randomized controlled study design. 80 patients with AN will be recruited from Shanghai Mental Health Center, There will be two groups: CBT treatment group and conventional treatment group. Each group is 40 and then the CBT group will be given standard CBT intervention for 12 weeks. The control group will receive outpatient treatment. To assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales, psychological scales and the security indexs will be used at baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up).
Detailed description
Eating disorder is a chronic mental disorder characteristic of abnormal eating behaviors and psychological disorders, accompanied by significant weight changes and physiological dysfunction. Many people with EDs have cognitive disorder of their body shape or body weight. Anorexia is a subtype of EDs. The main feature of anorexia nervosa is the extreme attention to body weight and body shape. As a result of this conflict the patients could be malnutrition, metabolism and endocrine disorders with significant weight loss. And women may have amenorrhea. At the mean time, the patient will also have a lot of mental symptoms such as depression, anxiety and obsession.
The disease mostly occurs in adolescents and young women. The prevalence rates in Europe and America is 0.5%-3.7%, 90% of which are women. The course of the disease is chronic, the average duration of disease is 4-6 years. Furthermore the mortality rate is high, a 20-year follow-up data shows that the mortality rate is nearly 20%. Most of the causes of death are physical complications and depression.
However, due to the special psychological behavior mechanism, patients have almost no willingness to be treated. As well as the long duration of disease and the highrisk of drug therapy, it all causes the great difficulties in the treatment. Many patients may even suffer from eating disorders for a lifetime. On another hand, the effective treatment options are still inconclusive. Psychotherapy, especially and cognitive behavior, is one of the most effective treatments at present.
On the other hand, psychotherapy is quite expensive, requiring not only a large number of qualified therapists, but also a long treatment time. Which leads to a high treatment cost. In order to reduce the cost of treatment, group therapy is a reasonable choice. However, currently there are no related research reports in china.
Our study is to examine whether the G-CBT for anorexia nervosa is effective or not. The study will use randomized controlled study design. 80 patients with AN will be recruited from Shanghai Mental Health Center, There will be two groups: CBT treatment group and conventional treatment group. Each group is 40 and then the CBT group will be given standard CBT intervention for 12 weeks. The control group will receive outpatient treatment. To assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales, psychological scales and the security indexs will be used at baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 24 weeks (3 months after treatment) and 36 weeks (6 months after treatment follow-up).
This study was designed with sufficient consideration about innovation as well as feasibility, and is to be operated on well proved theoretical basis and guidance of an operation manual. If successful, results of this study may bring great improvement to clinical practice of this refractory mental disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CBT group | Experimental | Behavioral: G-CBT, Other: Conventional treatmentG-CBT group has 40 patients, maybe will be divided them into 4 groups. Every group has 8-10 patients. Every group receive 10 times CBT group therapy and 1 times a week for 120 minutes each time. |
| Conventional treatment group | Active comparator | Other: Conventional treatmentConventional treatment group has 40 patients, received routine outpatient treatment. Once every two weeks for 45 minutes each time, including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 14-30 years;
- right handedness;
- above primary education;
- met DSM-V criteria for AN
Key exclusion criteria (2 listed)
- diagnosed with a mental illness;
- with severe physical or cognitive impairment
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 |
|---|---|---|
| G-CBTCBT is based on the model that there is a interaction between cognition, emotion and behavior. The way people think affects the way they feel and the behavior they do. And then the feelings in turn affect how they think,So it is valid for AN patient. | Behavioural | G-CBT group |
| Conventional treatmentConventional treatment including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders. | Other | Conventional treatment group, G-CBT group |
Primary outcome
Eating Disorder Examination Questionnaire(EDE-Q)
Time frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Eating Disorder Examination Questionnaire can evaluate the eating disorder behavior and psychology characteristics and assess their frequency and intensity, which can assess the severity of eating disorders.It is a 41 item self-report questionnaire. It retains the format of the EDE including the 4 subscales (1. Restraint; 2. Eating concern; 3. Shape concern; 4. Weight concern) and global score. It also concerns behaviors over a 28-day time period and retains the scoring system of 0-6, with 0 indicating no days, 1=1-5 days, 2=6-12 days, 3=13-15 days, 4=16-22 days, 5=23-27 days and 6= every day.The scoring method is the sum of the scores for each item divided by the number of items.
3 secondary outcomes
Eating Disorder Inventory(EDI)
Time frame: Change from Baseline eating attitudes and behaviors at 12weeks,24weeks,36weeks.
Beck Depression Inventory（BDI-II）
Time frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Beck Anxiety Inventory（BAI）
Time frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Background: PubMed 22271525Wonderlich S, Mitchell JE, Crosby RD, Myers TC, Kadlec K, Lahaise K, Swan-Kremeier L, Dokken J, Lange M, Dinkel J, Jorgensen M, Schander L. Minimizing and treating chronicity in the eating disorders: a clinical overview. Int J Eat Disord. 2012 May;45(4):467-75. doi: 10.1002/eat.20978. Epub 2012 Jan 23.
- Background: PubMed 25661898Groff SE. Is enhanced cognitive behavioral therapy an effective intervention in eating disorders? A review. J Evid Inf Soc Work. 2015;12(3):272-88. doi: 10.1080/15433714.2013.835756. Epub 2015 Jan 30.
- Background: PubMed 22879753Brown TA, Keel PK. Current and emerging directions in the treatment of eating disorders. Subst Abuse. 2012;6:33-61. doi: 10.4137/SART.S7864. Epub 2012 Mar 29.
- Background: PubMed 27462898Costa MB, Melnik T. Effectiveness of psychosocial interventions in eating disorders: an overview of Cochrane systematic reviews. Einstein (Sao Paulo). 2016 Apr-Jun;14(2):235-77. doi: 10.1590/S1679-45082016RW3120.
- Background: PubMed 19837012de Zwaan M, Hilbert A, Swan-Kremeier L, Simonich H, Lancaster K, Howell LM, Monson T, Crosby RD, Mitchell JE. Comprehensive interview assessment of eating behavior 18-35 months after gastric bypass surgery for morbid obesity. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):79-85. doi: 10.1016/j.soard.2009.08.011. Epub 2009 Sep 3.
- Background: PubMed 23084515Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Palmer RL, Dalle Grave R. Enhanced cognitive behaviour therapy for adults with anorexia nervosa: a UK-Italy study. Behav Res Ther. 2013 Jan;51(1):R2-8. doi: 10.1016/j.brat.2012.09.010. Epub 2012 Oct 22.
- Background: PubMed 22730260Watson HJ, Allen K, Fursland A, Byrne SM, Nathan PR. Does enhanced cognitive behaviour therapy for eating disorders improve quality of life? Eur Eat Disord Rev. 2012 Sep;20(5):393-9. doi: 10.1002/erv.2186. Epub 2012 Jun 22.
- Background: PubMed 26689208Dalle Grave R, El Ghoch M, Sartirana M, Calugi S. Cognitive Behavioral Therapy for Anorexia Nervosa: An Update. Curr Psychiatry Rep. 2016 Jan;18(1):2. doi: 10.1007/s11920-015-0643-4.
- Background: PubMed 24238470Polnay A, James VA, Hodges L, Murray GD, Munro C, Lawrie SM. Group therapy for people with bulimia nervosa: systematic review and meta-analysis. Psychol Med. 2014 Aug;44(11):2241-54. doi: 10.1017/S0033291713002791. Epub 2013 Nov 15.
- Derived from this study: PubMed 34526151Gu L, Zou Y, Huang Y, Liu Q, Chen H, Chen J. The effect of group cognitive behavior therapy on Chinese patients with anorexia nervosa: an open label trial. J Eat Disord. 2021 Sep 15;9(1):114. doi: 10.1186/s40337-021-00469-7.
- Individual participant dataSharing planned: Yes. The study protocol and baseline characteristics of participants
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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.
Jue Chen, PHD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-CBT and Conventional treatment in people with Feeding and Eating Disorders, run by Shanghai Mental Health Center at 1 site in China.
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 2 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 2 Jan 2020. 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 China. 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?
Contact Jue Chen, PHD (8618017311203, chenjue2088@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination Questionnaire(EDE-Q) (time frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,24weeks,36weeks.). 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 NCT03684239, 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 2 Jan 2020.