Objective: In this study we propose elucidating the pharmacokinetics of olanzapine in AN patients, to optimize the dosing strategy, to the extent of increasing the efficacy and reducing the risk of side effects. To this end, we will assess the…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Rationale: Anorexia nervosa (AN) is a debilitating eating disorder with one of
the highest mortality rates of all psychiatric disorders. In the Netherlands,
over 5.600 patients suffer from AN. The incidence rate is 1300 per year and
this number is still increasing. The path toward full recovery is often long
and only half of the patients recover completely after 10 years. As part of the
treatment of AN, olanzapine is frequently used to reduce severe anxiety,
agitation, and obsessive compulsions. Due to a dearth of pharmacokinetic
studies on olanzapine in this population with altered body composition, and the
limitations of side effects, doctors often doses low out of precaution. This
may result in subtherapeutic treatment and elongates the progression and the
treatment.
Study objective
Objective: In this study we propose elucidating the pharmacokinetics of
olanzapine in AN patients, to optimize the dosing strategy, to the extent of
increasing the efficacy and reducing the risk of side effects. To this end, we
will assess the pharmacokinetic differences of olanzapine between AN, and
non-AN patients, in adolescents and young adults.
We will investigate the relationship between the plasma levels of olanzapine in
steady state and side effects such as extrapyramidal symptoms (SAS), cardiac
abnormalities (ECG), sedation, and metabolic changes (full lipids spectrum).
Study design
Study design: We will conduct a multicenter cross-sectional study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit, and group relatedness:
This study is a non-interventional, observational study. The extra burden for
the participant includes 3 finger pricks and extra questionnaires (depending on
the questionnaires that are standard care in the participating center). Besides
local irritations of the finger pricks, the overall risks of these measurements
are negligible. The intensified and standardized follow-up might facilitate
early detection of side effects in participating patients. Moreover, should the
study succeed in demonstrating a relationship between drug plasma levels and
side effects, side effects in this vulnerable group may be limited in the
future by personalized therapeutic drug monitoring. Given the promising
position of olanzapine in the treatment of this persisting and debilitating
disease, this might be of high societal benefit.
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82751.078.23 |