De primary objective is to investigate the relationship between serum levels of before mentioned biochemical parameters (amino acid profile and monoaminergic parameters and the neurotrophic proteins BDNF and S-100B) and the symptomatology at…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The BPRS will be used as primary outcome measure. Secondary outcome measures
are the CGI-S and I. A clinical relevant improvement is defined as a reduction
of at least 40% on the BPRS total score..
Secondary outcome
Not applicable
Background summary
Since the introduction of the atypical antipsychotic risperidone, all
marketed novel antipsychotics have been evaluated for their efficacy in
patients with (relapsing) psychotic disorder of the schizophrenic type at the
Vincent van Gogh Institute for Psychiatry. In general, the efficacy of these
compounds appeared to be modest. With respect to biochemical parameters, at
baseline plasma levels of glutamate were demonstrated to be enhanced. This
increase persisted during the experimental period.
Over the past years the role of the neurotrophic proteins Brain Derived
Neurotrophic Factor (BDNF) and S-100B in the pathophysiology of psychotic
disorders has been investigated. . Serum levels of BDNF were found to be
decreased in patients with schizophrenic or bipolar spectrum disorders whereas
treatment with psychotropics resulted in an increase of it. (3,4). Serum
levels of S-100B appeared to be enhanced in patients with schizophrenia.
However, much is still unknown about the relationship between the neurotrophic
proteins BDNF and S-100B and the prognosis of psychotic disorders.
Study objective
De primary objective is to investigate the relationship between serum levels
of before mentioned biochemical parameters (amino acid profile and
monoaminergic parameters and the neurotrophic proteins BDNF and S-100B) and
the symptomatology at baseline and after 6 weeks standard treatment with an
antipsychotic. The secondary objective comprises a detailed evaluation of the
symptom profile and the effect of treatment in patients with schizophrenic or
bipolar spectrium disorders. The third objective is aimed to establish the
efficacy of treatment with antipsychotics in the patient group admitted for
(relapsing) psychosis in the psychiatric hospital Vincent van Gogh Institute
for Psychiatry.
Study design
Over a period of 2 years at least 100 patients admitted for a (relapse) of
their psychotic disorder will be evaluated during 6 weeks while receiving
treatment with psychotropics according to the treating psychiatrist. .
Selection of the patients will be performed by the treating psychiatrist and
the investigator. Symptom profile and effect of treatment will be assessed
by means of well known rating scales and will be related to the biochemical
parameters (monoamine metabolites and neurotrophic proteins)
Study burden and risks
The burden for participating patients will hardly be different from
non-participants, since the regular treatment of the psychiatric hospital will
be applied. In order to meet the exclusion criterion of a cytogenetic anomaly,
pictures will be taken that will be deleted after evaluation by the
clinical genetist. .
Stationsweg 46
5803 AC Venray
NL
Stationsweg 46
5803 AC Venray
NL
Listed location countries
Age
Inclusion criteria
age 18-65
psychotic disorder
legal competence
willing to participate
Exclusion criteria
unable to give informed consent
relevant somatic/neurologic disorder
cytogenetic aberration
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 | NL20469.097.07 |