The aim of this study is to validate EEG prediction markers of antipsychotic treatment outcome in patients with psychosis. *
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the primary outcome, patients will be divided into a responder and a
non-responder group based on the Positive and Negative Symptoms Scale (PANSS)
scores and remission criteria as defined by Andreasen and others.
*
Secondary outcome
Secondary outcomes include improvement on questionnaires for the quality of
life, general and physical health and functional outcome. Tertiary outcome
includes continuous changes in psychosis symptom levels as measured by the
PANSS.
Background summary
Psychosis is a disorder of disturbed contact with reality, characterized by
hallucinations, delusions, and disorganization of speech and behavior. Recovery
from psychosis is highly variable: some patients may experience a psychotic
episode briefly and only once, while others suffer from recurrent episodes or
chronic symptoms. The time between onset of a first psychotic episode (FEP) and
start of treatment is an important and modifiable predictor of outcome.
Antipsychotics are the first-choice treatment for patients with FEP. However,
in up to 40% of patients, remission is not achieved in response to the first
prescribed antipsychotic drug. Non-response only becomes clear after ten weeks
of treatment and is unpredictable. Clozapine is an antipsychotic with superior
response rates, but is only considered after non-response to two other
antipsychotics because of potential severe side-effects. Clozapine could be
prescribed up to six years earlier if non-response to other antipsychotics
could be predicted. Development of biomarkers for response to antipsychotic
treatment is therefore a crucial step towards personalized care for patients
with FEP, as it will improve long-term outcomes, speed up remission of
psychosis and prevent unnecessary side-effects in non-responders.
Recent advances in artificial intelligence in combination with suitable
biomarkers now allow a personalized approach to diagnosis and treatment in
psychosis patients. Electroencephalography (EEG) is a feasible and
cost-effective candidate biomarker that directly measures electrophysiological
brain activity with high temporal resolution. A pilot study showed that
clozapine treatment response in otherwise treatment-resistant schizophrenia
patients could be predicted with 85% accuracy. We have also shown the merit of
machine learning of quantitative EEG characteristics in previous studies in
other disorders including dementia and delirium, and found diagnostic
accuracies based on this information up to 95%. To improve prediction and
identification of the underlying biological processes we will make use of the
ability to investigate changes in the regulation of gene transcription by
investigating changes in DNA methylation in whole blood as done previously in
treatment studies by our group.
Study objective
The aim of this study is to validate EEG prediction markers of antipsychotic
treatment outcome in patients with psychosis.
*
Study design
Study design: The study will be a mono-center observational cohort study, in
collaboration with referring clinical centers in the Utrecht area, Amsterdam
UMC, and UMC Groningen. Detailed patient information will be obtained at
baseline, before patients start with antipsychotic treatment. An EEG recording
and blood sample for DNA analysis will also be obtained at baseline. Follow-up
will be scheduled at clinical evaluation points after (1) 4-6 weeks and (2)
after 10-15 weeks of treatment-as-usual. Retrospectively, patients will be
divided in responders and non-responders based on these assessment. An
additional EEG recording and blood sample will be obtained at the second
follow-up visit.
*
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Most measurements included in this study are
non-invasive measurements, except for small blood samples we will draw, and
will not require additional patient visits. The visits for the standard of care
require additional time investment for questionnaires, EEG -data recording and
blood sampling. The burden and risks are low to very low. Patients will
receive 20 euro of compensation per visit for the participation in the study.
Also, patients who participate receive a detailed report of the measurements
(questionnaires, EEG). This can lead to a better understanding of their
complaints, functioning and if applicable, of their diagnosis. The main
objective is to develop prediction markers so future patients may have benefit
in their treatment success.
*
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Age between 16 and 55 years old
- Psychotic episode
- Patients who are going to start or recently have started antipsychotic
treatment (<2
weeks prior to baseline visit)
- The participant needs to understand the study and is able to provide written
informed consent.
Exclusion criteria
- Coercive measures. With exception of "zorg machtiging" if a patient wants to
start with antipsychotics voluntarily and the patient is competent of making
decisions.
- A history of mental retardation
- Organic brain damage
- Organic psychosis
- Patients who are pregnant or patients who are breastfeeding.
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 | NL74495.041.20 |
| Other | NL8725 |