Anorexia nervosa
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: We aim to assess the pharmacokinetic parameters of olanzapine in AN patients. To this end, we will assess the pharmacokinetic differences of olanzapine between AN and non-AN patients, in adolescents and young adults. | — |
Secondary
| Measure | Time frame |
|---|---|
| In a second pharmacodynamic (PD) analysis we will investigate the relationship between the pharmacokinetic model and cardiac changes, extrapyramidal symptoms, metabolic abnormalities, somnolence, and clinical effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactB.C.M. Winter
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed