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New treatment option for Anorexia Nervosa
Official title Deep Brain Stimulation for Severe Anorexia Nervosa
ClinicalTrials.gov ID: NCT05245643
What this study is testing
- What it's testing
- The somatic complications as well as the suicidal risk make Anorexia Nervosa (AN) the psychiatric disease with the highest mortality rate: the standardized mortality ratio is higher than 4 and 1 in 5 patients with AN who dies has committed suicide. Approximately 20% of patients suffering from AN evolves into a chronic form without prolonged remission.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Diagnosis of Anorexia nervosa according to DSM V criteria.
- Age 18 to 65 years.
- Chronic, treatment-resistant anorexia nervosa, defined as:
- Anorexia nervosa evolving for at least 7 years.
- Inability to maintain a BMI ≥ 17kg/m² for 2 months following hospitalization in a center specialized for the management of patients suffering from...
You likely can't join if
- Presence of an Axis I disorder that is primary to anorexia nervosa.
- Presence of a personality disorder that could compromise compliance with post-surgical follow-up assessed by 2 independent experts
- Presence of severe neurological pathology or significant MRI abnormalities (excluding anorexia-related atrophy).
- Cognitive and intellectual ability to understand the risks and constraints of the technique or to give informed consent.
- Albumin levels \<30g/L.
- Presence of medical contraindications to undergo implantation of a DBS system or to realize an MRI (pacemaker).
See the full eligibility criteria
- Diagnosis of Anorexia nervosa according to DSM V criteria.
- Age 18 to 65 years.
- Chronic, treatment-resistant anorexia nervosa, defined as:
- Anorexia nervosa evolving for at least 7 years.
- Inability to maintain a BMI ≥ 17kg/m² for 2 months following hospitalization in a center specialized for the management of patients suffering from eating disorders according to the criteria of the French Federation of...
- Inability to maintain a BMI ≥ 17kg/m² for more than 3 consecutive months during an outpatient treatment conducted by a team specialized for the care of patients suffering from eating disorders according to the criteria...
- Impaired psychological, social and occupational functioning defined by a score ≤ 45 on the Global Assessment of Functioning Scale.
- Anorexia nervosa is judged to be the primary disorder if there are psychiatric comorbidities such as depression, anxiety disorder, obsessive-compulsive disorder, or personality disorder by at least two independent...
- The patient is able to comply with the operational and administrative requirements of the study and is able to complete the protocol forms.
- Patient provides written informed consent.
- Patient is drug-free or on a medication that has been stable for at least 6 weeks at the time of study entry.
- If female subject and of childbearing age: use of an effective method of contraception.
- Membership in a health insurance plan or beneficiary.
- Presence of an Axis I disorder that is primary to anorexia nervosa.
- Presence of a personality disorder that could compromise compliance with post-surgical follow-up assessed by 2 independent experts
- Presence of severe neurological pathology or significant MRI abnormalities (excluding anorexia-related atrophy).
- Cognitive and intellectual ability to understand the risks and constraints of the technique or to give informed consent.
- Albumin levels \<30g/L.
- Presence of medical contraindications to undergo implantation of a DBS system or to realize an MRI (pacemaker).
- Pregnant or breastfeeding woman.
- Previous DBS.
- Trusted person and/or family object to patient's participation.
- Contraindication to general anesthesia.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.