Schizophrenia Clinical Trial
Official title:
Positron Emission Tomography(PET) With 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 Fluorine(F)]DOPA) Determinants and Predictors of Treatment Response in Psychosis
The first purpose of this study is to determine if dopamine synthesis capacity is significantly lower in treatment non-responders from illness onset relative to treatment responders. And the second purpose of this study is to determine the potential of [18 fluorine(F)]-DOPA to be used to predict treatment response to antipsychotic treatment in first episode psychosis.
Schizophrenia is amongst the leading causes of global disability in adults. A major factor
underlying this is that about 30% of patients show little or no response to first-line
antipsychotic drugs. There is one drug, clozapine, with proven efficacy in these patients.
However, currently there are no good predictors of treatment non-response and consequently
patients have to undergo empirical trials with first-line drugs. This contributes to the long
delays, on average 4-5 years, seen in identifying and starting patients on clozapine.
Furthermore, clozapine is poorly tolerated and has potentially life-threatening side-effects,
which mean that the investigators desperately need new, alternative drugs. Lack of
understanding of the neurobiological basis underlying non-response has impeded the
development of alternatives to clozapine in the past. However recently it has been shown that
non-responders show reduced dopamine synthesis capacity relative to patients who have
responded to antipsychotics. The effect size for this difference is very large, d>1.2. This
study was cross-sectional, in patients who had already received antipsychotic treatment for a
number of years. The key questions now are thus:
1. is dopamine synthesis capacity different at illness onset in drug naïve patients who
subsequently show non-response to antipsychotic treatment relative to drug naïve
patients who respond to treatment
2. is it possible to predict who will respond to treatment
To test this the investigators are going to investigate the relationship between presynaptic
dopamine dysfunction and antipsychotic responsiveness in a prospective study.
For this, the investigators are going to measure striatal dopamine synthesis capacity using
[18 fluorine(F)]DOPA positron emission tomography in drug-naïve first episode psychosis and
determine treatment response after 6 weeks of treatment with amisulpride. Response will be
defined as a >30% reduction in symptom ratings on the Positive and Negative Syndrome Scale.
The effect size in our cross-sectional study was d=1.3. Based on this effect size a sample
size of 12 per group will have >80% power to detect a group difference with p<0.05 2-tailed
using an independent t-test. Given a non-response rate of 30% the investigators will thus
require 40 patients at baseline to get 12 non-responders. To allow for 20% drop-outs we will
require 50 patients at baseline.
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