Binge-Eating DisorderACCElectNCT04572087
Ameliorating Cognitive Control in Binge Eating Disorder
A study testing Behavioral training and verum stimulation in people with Binge-Eating Disorder, run by Prof. Dr. Katrin Giel at 1 site in Germany.
Trial summary
There is evidence that impairment of impulse regulation is involved in the development and maintenance of eating disorders, especially in Binge Eating Disorder (BED). BED is characterized by recurrent episodes of binge eating with experienced loss of control over eating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Behavioral training and verum stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 8 Sep 2020to 9 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BED according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Legal age
- BMI above 20 kg/m2
Who cannot join
- Insufficient knowledge of German language
- Current pregnancy or lactation period
- Current or lifetime psychotic disorder, bipolar-I disorder, current substance dependence, suicidality
- Past bariatric surgery
- Severe physical disease which influence weight or eating behaviour (e.g. severe diabetes) or neurologic disease
- Non-removable metal parts in the area of the head
Show all 9Show fewer
- Pacemaker
- Neuroleptics and benzodiazepine
- impaired vision, ametropia, eye diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ameliorating Cognitive Control in Binge Eating Disorder by Electrical Brain Stimulation
There is evidence that impairment of impulse regulation is involved in the development and maintenance of eating disorders, especially in Binge Eating Disorder (BED). BED is characterized by recurrent episodes of binge eating with experienced loss of control over eating. Controlling impulsive behaviour, cognitive flexibility, planning and decision making are key abilities of impulse regulation. Some of these impaired cognitive functions are linked to decreased activity of certain brain regions. Transcranial direct current stimulation (tDCS) is a well-established method to alter brain activity. In the current project, we explore if a computer-assisted training programme for patients with BED that is combined with tDCS is feasible and able to ameliorate impulse regulation and impulsive eating behaviour. We hypothesize that the cognitive training programme with additional tDCS will result in a greater decrease of BED symptoms and a stronger increase in impulse regulation skills compared with the cognitive training programme without tDCS by using a placebo stimulation.
Read the detailed description
Patients with BED form a subgroup of obese patients with a disinhibited eating pattern that is associated with major impairments in cognitive control. The dorsolateral prefrontal cortex (dlPFC) has been identified as a brain region closely tied to cognitive control processes and crucially involved in the control of eating behaviour. This suggests the dlPFC as a target for the modulation of cognitive control processes over eating in BED. This modulation can be achieved by both, a cognitive training task and by noninvasive brain stimulation using tDCS. In studies with healthy normal-weight participants, (1) different cognitive training task enhance control over eating behaviour, (2) tDCS is an effective tool to ameliorate cognitive control processes, and (3) has beneficial effects on motivational aspects of eating behaviour, i.e. food craving. Based on this evidence, we will use a combination of a cognitive control task and tDCS to enhance cognitive control over eating in patients with BED. This is to the best of our knowledge one of the first studies to use tDCS as an intervention to enhance cognitive control over eating in patients with BED.
- Sample size: We will allocate 40 patients in the trial, i.e. 20 patients in each study arm.
- Recruitment: Patients are recruited by announcements, mails to the distributor list of the university hospital, existing databases of patients, and current patients of the university hospital. Patients are screened by a standardized checklist. In- and exclusion criteria are checked during the screening procedure and during the baseline diagnostic before randomisation.
- Standard Operating Procedures: For the recruitment, diagnostic and experimental sessions, Standard Operating Procedures are documented for the experimenter. This includes the order of clinical interviews, questionnaires and operating with the technical measurement instruments. The experimenters are regularly supervised. All adverse events will be listed and severe adverse events will be reported immediately to the PIs.
- Quality assurance plan: Randomized allocation to the stimulation condition (verum vs. sahm) and statistical analyses is done externally by the Institute of Clinical Epidemiology and Applied Biometry, University Tübingen, Germany (ICEAB). Objective technical measurement instruments are mostly used to record data.
- Data checks: Data is recorded mostly by objective technical measurement instruments, so no external monitoring is needed. We will spot check entered questionnaire data, in particular binge eating frequency in the past four weeks will be double checked as this is the primary outcome (PO).
- Source data verification: Data are spot checked by comparing the entries in the source data with the entries in the database. Each PO entry will be double checked. There are pre-defined criteria for entering data into the database.
- Data dictionary:
A data dictionary that contains detailed descriptions of each variable and how to be entered is available.
- Plan for missing data: Missing data and invalid data as well as the reasons will be recorded.
- Statistical analysis plan: A mixed model approach will be used to analyze the PO and secondary outcomes (SOs).
- Conditions
- Binge-Eating Disorder
- Being tested
- Behavioral training and verum stimulation, Behavioral training and sham stimulation
- Keywords
- Brain stimulation, cognitive control, behavioral training, binge eating disorder, response inhibition, eye tracking, eating disorder, impulsivity
- Medical subject headings
- Binge-Eating Disorder, Feeding and Eating Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral training and verum stimulationOther
Cognitive control training and verum tDCS
Behavioral training and sham stimulationOther
Cognitive control training and sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Control Training + Verum stimulation | Experimental | This arm consists of the cognitive control training (six sessions) combined with 2mA anodal tDCS over the right dlPFC (F4) during the training for 20 minutes. Receives: Other: Behavioral training and verum stimulation |
| Cognitive Control Training + Sham stimulation | Active comparator | This arm consists of cognitive control training (six sessions) with sham-tDCS. 2 mA Sham-tDCS (40 seconds of tDCS) is applied to the right dlPFC (F4) before the trainings starts. Receives: Other: Behavioral training and sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge eating frequency
Change of the frequency of Binge eating episodes in the last 4 weeks according to the Eating Disorder Examination Interview (EDE) between baseline (T0) and diagnostic post assessment (T8). The EDE is a validated semi-structured clinical interview.
Measured: assessed at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Secondary outcomes (14)
Binge eating frequency follow-up
Change of the frequency of Binge eating episodes in the last 4 weeks according to EDE between baseline (T0) and 3 months follow up (T9)
Measured: assessed at baseline (T0) and at 3 months follow-up (T9)
antisaccade task
antisaccade task error rate and latency assessed by eye tracking
Measured: assessed at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
Go/No-Go task
Go/No-Go task task error rate and latency
Measured: at baseline (T0) and at the post measurement of task performance within one week after the training (T7)
stimulus rating
one self-developed questionnaire including visual analogue scales (0-10 cm) concerning valence, appetite, wanting, liking of the presented stimuli
Measured: at baseline (T0) and and the post measurement of task performance within one week after the training (T7)
Eating disorder pathology (EDE)
assessed by the Eating Disorder Examination (EDE), Range 0-6 with higer scores indication higer eating disorder pathology
Measured: assessed at baseline (T0), at diagnostic post assessment four weeks after treatment (T8) and 3 months follow-up (T9)
eating behaviour (TFEQ)
assessed by the Three-factor Eating Questionnaire (TFEQ), Range 0-1 with higher scores indicating more pathological eating behaviour
Measured: at baseline (T0), at the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
food craving (FCQ-S)
assessed by the Food Craving Questionnaire, State Version (FCQ-S), Range 1-5 with higher scores indicating higher food craving
Measured: at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
impulsive behaviours per week
assessed by a self-developed process analysis questionnaire, values > 0 (unlimited frequency) with higher scores indicating more impulsive behaviours per week
Measured: at baseline (T0), the six training sessions within two weeks (T1-T6), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
impulsivity (UPPS)
assessed by the "UPPS Impulsive Behavior Scale" (UPPS), Range 1-4 with higher scores indicating higher impulsivity
Measured: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
well-being (WHO-5)
assessed by the "WHO (Five) - Well-being Questionnaire" (WHO-5), Range 0-5 with higher scores indicating higher well-being
Measured: at baseline (T0), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
depressive symptoms (BDI II)
assessed by the Becks Depression Inventory, Version 2 (BDI II), Range 0-3 with higher scores indicating higher depressive symptoms
Measured: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Body Mass Index (BMI)
computed by objectively assessed weight and height
Measured: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
acceptance and feasibility
drop-out rate throughout T0 to T9, percentage of included patients from the eligible patients at T0
Measured: from baseline (T0) throughout all measurement points until 3 months follow-up (T9)
evaluation of the training programme
self-developed questionnaire at T7 (Range 1-5 with higher cores indicating more satisfaction with the training programme)
Measured: assessed at the post measurement of task performance within one week after the training (T7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start8 Sep 2020
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the baseline measure (T0) without tDCS, participants are randomized to either the group that receives 6 training sessions (T1-T6) with 2 milliampere (ma) anodal tDCS to the right dlPFC or the group that receives 6 training sessions and sham tDCS. After the six training sessions within 2 weeks a post measurement concerning task performance (T7) without tDCS takes place. 4 Weeks after treatment, the diagnostic post measurement (T8) will be executed. 3 months later, a follow-up via phone (T9) will be done.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Katrin Giel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Katrin Giel, University Hospital Tuebingen
- Investigators
- Katrin E Giel, Prof. Dr., Principal investigator, University Hospital TuebingenChristian Plewnia, Prof. Dr., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572087
- Sponsor's protocol ID
- GI 878/4-1
- Other IDs
- PL 525/7-1
- Acronym
- ACCElect
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2020
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Max SM, Plewnia C, Zipfel S, Giel KE, Schag K. Combined antisaccade task and transcranial direct current stimulation to increase response inhibition in binge eating disorder. Eur Arch Psychiatry Clin Neurosci. 2021 Feb;271(1):17-28. doi: 10.1007/s00406-020-01164-5. Epub 2020 Jul 13.
PubMed 32661703Schag K, Ince B, Zipfel S, Max S, Plewnia C, Giel K. [Non-Invasive Brain Stimulation in the Treatment of Eating Disorders - A Narrative Review]. Psychother Psychosom Med Psychol. 2020 Jun;70(6):246-251. doi: 10.1055/a-1156-8899. Epub 2020 Jun 9. German.
PubMed 32516813Giel KE, Schag K, Martus P, Max SM, Plewnia C. Ameliorating cognitive control in patients with binge eating disorder by electrical brain stimulation: study protocol of the randomized controlled ACCElect pilot trial. J Eat Disord. 2022 Feb 19;10(1):26. doi: 10.1186/s40337-022-00544-7.
PubMed 35183261
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorating Cognitive Control in Binge Eating Disorder by Electrical Brain Stimulation
- ClinicalTrials.gov ID
- NCT04572087
- Acronym / sponsor ID
- ACCElect / GI 878/4-1
- Conditions
- Binge-Eating Disorder
- Keywords
- Brain stimulation, cognitive control, behavioral training, binge eating disorder, response inhibition, eye tracking, eating disorder, impulsivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Prof. Dr. Katrin GielUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 1 Oct 2020 (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.
There is evidence that impairment of impulse regulation is involved in the development and maintenance of eating disorders, especially in Binge Eating Disorder (BED). BED is characterized by recurrent episodes of binge eating with experienced loss of control over eating. Controlling impulsive behaviour, cognitive flexibility, planning and decision making are key abilities of impulse regulation. Some of these impaired cognitive functions are linked to decreased activity of certain brain regions. Transcranial direct current stimulation (tDCS) is a well-established method to alter brain activity. In the current project, we explore if a computer-assisted training programme for patients with BED that is combined with tDCS is feasible and able to ameliorate impulse regulation and impulsive eating behaviour. We hypothesize that the cognitive training programme with additional tDCS will result in a greater decrease of BED symptoms and a stronger increase in impulse regulation skills compared with the cognitive training programme without tDCS by using a placebo stimulation.
Detailed description
Patients with BED form a subgroup of obese patients with a disinhibited eating pattern that is associated with major impairments in cognitive control. The dorsolateral prefrontal cortex (dlPFC) has been identified as a brain region closely tied to cognitive control processes and crucially involved in the control of eating behaviour. This suggests the dlPFC as a target for the modulation of cognitive control processes over eating in BED. This modulation can be achieved by both, a cognitive training task and by noninvasive brain stimulation using tDCS. In studies with healthy normal-weight participants, (1) different cognitive training task enhance control over eating behaviour, (2) tDCS is an effective tool to ameliorate cognitive control processes, and (3) has beneficial effects on motivational aspects of eating behaviour, i.e. food craving. Based on this evidence, we will use a combination of a cognitive control task and tDCS to enhance cognitive control over eating in patients with BED. This is to the best of our knowledge one of the first studies to use tDCS as an intervention to enhance cognitive control over eating in patients with BED.
- Sample size: We will allocate 40 patients in the trial, i.e. 20 patients in each study arm.
- Recruitment: Patients are recruited by announcements, mails to the distributor list of the university hospital, existing databases of patients, and current patients of the university hospital. Patients are screened by a standardized checklist. In- and exclusion criteria are checked during the screening procedure and during the baseline diagnostic before randomisation.
- Standard Operating Procedures: For the recruitment, diagnostic and experimental sessions, Standard Operating Procedures are documented for the experimenter. This includes the order of clinical interviews, questionnaires and operating with the technical measurement instruments. The experimenters are regularly supervised. All adverse events will be listed and severe adverse events will be reported immediately to the PIs.
- Quality assurance plan: Randomized allocation to the stimulation condition (verum vs. sahm) and statistical analyses is done externally by the Institute of Clinical Epidemiology and Applied Biometry, University Tübingen, Germany (ICEAB). Objective technical measurement instruments are mostly used to record data.
- Data checks: Data is recorded mostly by objective technical measurement instruments, so no external monitoring is needed. We will spot check entered questionnaire data, in particular binge eating frequency in the past four weeks will be double checked as this is the primary outcome (PO).
- Source data verification: Data are spot checked by comparing the entries in the source data with the entries in the database. Each PO entry will be double checked. There are pre-defined criteria for entering data into the database.
- Data dictionary:
A data dictionary that contains detailed descriptions of each variable and how to be entered is available.
- Plan for missing data: Missing data and invalid data as well as the reasons will be recorded.
- Statistical analysis plan: A mixed model approach will be used to analyze the PO and secondary outcomes (SOs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After the baseline measure (T0) without tDCS, participants are randomized to either the group that receives 6 training sessions (T1-T6) with 2 milliampere (ma) anodal tDCS to the right dlPFC or the group that receives 6 training sessions and sham tDCS. After the six training sessions within 2 weeks a post measurement concerning task performance (T7) without tDCS takes place. 4 Weeks after treatment, the diagnostic post measurement (T8) will be executed. 3 months later, a follow-up via phone (T9) will be done.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Control Training + Verum stimulation | Experimental | Other: Behavioral training and verum stimulationThis arm consists of the cognitive control training (six sessions) combined with 2mA anodal tDCS over the right dlPFC (F4) during the training for 20 minutes. |
| Cognitive Control Training + Sham stimulation | Active comparator | Other: Behavioral training and sham stimulationThis arm consists of cognitive control training (six sessions) with sham-tDCS. 2 mA Sham-tDCS (40 seconds of tDCS) is applied to the right dlPFC (F4) before the trainings starts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BED according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Legal age
- BMI above 20 kg/m2
Key exclusion criteria (9 listed)
- Insufficient knowledge of German language
- Current pregnancy or lactation period
- Current or lifetime psychotic disorder, bipolar-I disorder, current substance dependence, suicidality
- Past bariatric surgery
- Severe physical disease which influence weight or eating behaviour (e.g. severe diabetes) or neurologic disease
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 |
|---|---|---|
| Behavioral training and verum stimulationCognitive control training and verum tDCS | Other | Cognitive Control Training + Verum stimulation |
| Behavioral training and sham stimulationCognitive control training and sham tDCS | Other | Cognitive Control Training + Sham stimulation |
Primary outcome
Binge eating frequency
Time frame: assessed at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Change of the frequency of Binge eating episodes in the last 4 weeks according to the Eating Disorder Examination Interview (EDE) between baseline (T0) and diagnostic post assessment (T8). The EDE is a validated semi-structured clinical interview.
14 secondary outcomes
Binge eating frequency follow-up
Time frame: assessed at baseline (T0) and at 3 months follow-up (T9)
antisaccade task
Time frame: assessed at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
Go/No-Go task
Time frame: at baseline (T0) and at the post measurement of task performance within one week after the training (T7)
stimulus rating
Time frame: at baseline (T0) and and the post measurement of task performance within one week after the training (T7)
Eating disorder pathology (EDE)
Time frame: assessed at baseline (T0), at diagnostic post assessment four weeks after treatment (T8) and 3 months follow-up (T9)
eating behaviour (TFEQ)
Time frame: at baseline (T0), at the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
food craving (FCQ-S)
Time frame: at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
impulsive behaviours per week
Time frame: at baseline (T0), the six training sessions within two weeks (T1-T6), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
impulsivity (UPPS)
Time frame: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
well-being (WHO-5)
Time frame: at baseline (T0), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
depressive symptoms (BDI II)
Time frame: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Body Mass Index (BMI)
Time frame: at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
acceptance and feasibility
Time frame: from baseline (T0) throughout all measurement points until 3 months follow-up (T9)
evaluation of the training programme
Time frame: assessed at the post measurement of task performance within one week after the training (T7)
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 27 May 2022.
- Background: PubMed 32661703Max SM, Plewnia C, Zipfel S, Giel KE, Schag K. Combined antisaccade task and transcranial direct current stimulation to increase response inhibition in binge eating disorder. Eur Arch Psychiatry Clin Neurosci. 2021 Feb;271(1):17-28. doi: 10.1007/s00406-020-01164-5. Epub 2020 Jul 13.
- Background: PubMed 32516813Schag K, Ince B, Zipfel S, Max S, Plewnia C, Giel K. [Non-Invasive Brain Stimulation in the Treatment of Eating Disorders - A Narrative Review]. Psychother Psychosom Med Psychol. 2020 Jun;70(6):246-251. doi: 10.1055/a-1156-8899. Epub 2020 Jun 9. German.
- Background: PubMed 35183261Giel KE, Schag K, Martus P, Max SM, Plewnia C. Ameliorating cognitive control in patients with binge eating disorder by electrical brain stimulation: study protocol of the randomized controlled ACCElect pilot trial. J Eat Disord. 2022 Feb 19;10(1):26. doi: 10.1186/s40337-022-00544-7.
- research information of the University Tübingen, GermanyLink provided by the sponsor.
- 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.
Katrin E Giel, Prof. Dr. principal investigator
University Hospital Tuebingen
Christian Plewnia, Prof. Dr. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral training and verum stimulation in people with Binge-Eating Disorder, run by Prof. Dr. Katrin Giel at 1 site in Germany.
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 9 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 27 May 2022. 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 Germany. 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?
Binge eating frequency (time frame: assessed at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)). 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 NCT04572087, which also lists 3 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 27 May 2022.