TOwaRds PrEcision Dosing of Olanzapine in anorexia nervosa patients
- Conditions
- Anorexia nervosa10014067
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
AN group
• Age 12 to 30 years
• Diagnosis according to DSM-5 criteria for anorexia nervosa
• Documented clinical indication for treatment with olanzapine
• Treatment with olanzapine (including current users and recent starters)
• Signed informed consent
Non-AN group
• Age 12 to 30 years
• Documented clinical indication for treatment with olanzapine
• Treatment with olanzapine (including current users and recent starters)
• Signed informed consent
AN group
• Co-medications: carbamazepine, lopinavir, rifampicin, ritonavir,
ciprofloxacin and fluvoxamine.
• Pregnancy
• The congenital or acquired syndrome is associated with changes in appetite,
body weight, or lipid profile (e.g. Prader Willi)
Non-AN group:
• Diagnosis according to DSM-5 criteria for anorexia nervosa
• Co-medications: carbamazepine, lopinavir, rifampicin, ritonavir,
ciprofloxacin and fluvoxamine.
• Pregnancy
• The congenital or acquired syndrome is associated with changes in appetite,
body weight, or lipid profile (e.g. Prader Willi)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: We aim to assess the pharmacokinetic<br /><br>parameters of olanzapine in AN patients. To this end, we will assess the<br /><br>pharmacokinetic differences of olanzapine between AN and non-AN patients, in<br /><br>adolescents and young adults.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In a second pharmacodynamic (PD) analysis we will investigate the relationship<br /><br>between the pharmacokinetic model and cardiac changes, extrapyramidal symptoms,<br /><br>metabolic abnormalities, somnolence, and clinical effectiveness. </p><br>