Eating DisordersNCT02829645
Evaluation of the Clinical, Neuropsychological and Psychosocial Situation of Patient With Eating Disorders.
A study testing Clinical assessment in people with Eating Disorders, run by University Hospital, Montpellier.
Trial summary
Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects in the quality of life of patients and thier relatives. Management of ED is very difficult : the prognosis remains relatively poor both in terms of remission rate and quality of life. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Clinical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Oct 2017
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- respond to DSM 4 criteria for ED
- Age 15 to 65 years
- Signing an informed consent.
- Affiliated to a social security scheme or being the beneficiary of such a scheme.
Who cannot join
- Manifest inability of the subject to understand / perform clinical and neuropsychological evaluations and tasks
- Major protected by law (guardianship)
- Privation of liberty by judicial or administrative decision
- Pregnant or lactating women
About this study
Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects in the quality of life of patients and thier relatives. Management of ED is very difficult : the prognosis remains relatively poor both in terms of remission rate and quality of life. In this context, the contribution of new strategies for pathophysiological exploration and the development of therapeutic options are crucial.
In this project the investigators aim to constitute un cohort of patients from a day unit specialized in the management of ED. A prospective follow-up will be offered to patients to assess their clinical and psycho-social evolution. The overall objective is to identify which factors are prognostic of clinical improvement of the ED. We also want to better characterize patients that will migrate from diagnosis to another.
Read the detailed description
The investigators propose to assess, with a cohort of patients with ED the prognostic value of cognitive abnormalities associated with ED (cognitive flexibility and central coherence) They will recruit 370 patients suffering from a current ED (anorexia, bulimia, binge eating disorder, Eating disorder not otherwise specified).
Each patient will be reassessed every year for 3 years.
- Conditions
- Eating Disorders
- Being tested
- Clinical assessment
- Keywords
- eating disoders, neuropsychology, pronostic
- 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.
Clinical assessmentOther
Clinical assessment with questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Eating disorders | Other | Not described Receives: Other: Clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of remission rates
study of remission rates frequency at 12 months depending on the Brixton score assessed at baseline (assessment of cognitive flexibility). Remission is defined as disappearance of ED Diagnostic and Statistical Manual (DSM) criteria.
Measured: At the inclusion and at 12, 24 and 36 months
Secondary outcomes (3)
score to another neuropsychological test (Iowa gambling task (IGT)
Study of remission rates frequency at 12 months depending on the IGT score (decision making) assessed at baseline
Measured: At the inclusion and at 12, 24 and 36 months
scores to another other neuropsychological test : Rey-Osterrieth complex figure
Study of remission rates frequency at 12 months depending on the Rey figure assessed at baseline
Measured: At the inclusion and at 12, 24 and 36 months
scores to another neuropsychological test : D2 test of attention
Study of remission rates frequency at 12 months depending on the D2 test (attention) assessed at baseline
Measured: At the inclusion and at 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startFeb 2012
- Primary completionOct 2014
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829645
- Sponsor's protocol ID
- UF 8854
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical, Neuropsychological and Psychosocial Situation of Patient With Eating Disorders.
- ClinicalTrials.gov ID
- NCT02829645
- Acronym / sponsor ID
- UF 8854
- Conditions
- Eating Disorders
- Keywords
- eating disoders, neuropsychology, pronostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 12 Jul 2016 (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.
Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects in the quality of life of patients and thier relatives. Management of ED is very difficult : the prognosis remains relatively poor both in terms of remission rate and quality of life. In this context, the contribution of new strategies for pathophysiological exploration and the development of therapeutic options are crucial.
In this project the investigators aim to constitute un cohort of patients from a day unit specialized in the management of ED. A prospective follow-up will be offered to patients to assess their clinical and psycho-social evolution. The overall objective is to identify which factors are prognostic of clinical improvement of the ED. We also want to better characterize patients that will migrate from diagnosis to another.
Detailed description
The investigators propose to assess, with a cohort of patients with ED the prognostic value of cognitive abnormalities associated with ED (cognitive flexibility and central coherence) They will recruit 370 patients suffering from a current ED (anorexia, bulimia, binge eating disorder, Eating disorder not otherwise specified).
Each patient will be reassessed every year for 3 years.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eating disorders | Other | Other: Clinical assessment |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- respond to DSM 4 criteria for ED
- Age 15 to 65 years
- Signing an informed consent.
- Affiliated to a social security scheme or being the beneficiary of such a scheme.
Key exclusion criteria (4 listed)
- Manifest inability of the subject to understand / perform clinical and neuropsychological evaluations and tasks
- Major protected by law (guardianship)
- Privation of liberty by judicial or administrative decision
- Pregnant or lactating women
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 |
|---|---|---|
| Clinical assessmentClinical assessment with questionnaires | Other | Eating disorders |
Primary outcome
Frequency of remission rates
Time frame: At the inclusion and at 12, 24 and 36 months
study of remission rates frequency at 12 months depending on the Brixton score assessed at baseline (assessment of cognitive flexibility). Remission is defined as disappearance of ED Diagnostic and Statistical Manual (DSM) criteria.
3 secondary outcomes
score to another neuropsychological test (Iowa gambling task (IGT)
Time frame: At the inclusion and at 12, 24 and 36 months
scores to another other neuropsychological test : Rey-Osterrieth complex figure
Time frame: At the inclusion and at 12, 24 and 36 months
scores to another neuropsychological test : D2 test of attention
Time frame: At the inclusion and at 12, 24 and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment in people with Eating Disorders, run by University Hospital, Montpellier.
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 4 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of remission rates (time frame: At the inclusion and at 12, 24 and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2016.