Schizophrenia Clinical Trial
Official title:
Dopaminergic Modulation of Prefrontal Functions in Schizophrenic Patients: Adjuvant Therapy With Pergolide
The objective of this study is to compare the modulation of pergolide, a D1/D2 receptor agonist, to placebo in non-acute schizophrenic subjects under concomitant therapy with atypical antipsychotics on specific PFC functions. Further aims are to assess the influence of pergolide on psychopathology and extrapyramidal symptoms in comparison to placebo.
Additionally to the desired treatment of positive symptoms, the administration of typical
neuroleptics can lead to undesired side effects such as increase of negative symptomatic and
cognitive deficits. The influence of atypical neuroleptics on cognition is still not very
well studied. Furthermore there is evidence that some cognitive symptoms seen in
schizophrenia are related to a disturbance in the prefrontal cortex PFC and involve specific
subtypes of dopamine receptors, namely D1 subtypes, which predominates in this area. It is
assumed that patients with this spectrum of cognitive deficits have the worse course and
prognosis. Furthermore these deficits are more therapy resistant to the conventional current
therapy approaches. There is however some evidence pointing to a positive influence of
dopamine agonists on these deficits, but the selective effect of dopamine sub-receptors is
still not well investigated. The aim of the study is to examine whether cognitive deficits
in higher cognitive functions of the PFC such as working memory, semantic association and
executive control improves under dopamine agonistic therapy in schizophrenia and whether
this is related to selective D1 modulation.
We predict that the modulation of D1 subtype receptors improve performance in each of these
tasks. Because there is no D1 agonist available for human research we decided to use a
design comparing a dopamine agonist with mixed D1 and D2 agonistic properties (pergolide) to
placebo under a stable D2 antagonistic continuous-therapy with atypical antipsychotics. With
this design the D2-component of pergolide can be antagonized by the atypical antipsychotics
and a D1 agonistic effect can be suggested, as well as protecting patients against a
psychotic re-exacerbation. With this study we aim to bring more insight in the therapy of
PFC cognitive deficits of schizophrenia by helping to elucidate the role of selective
agonists on cognition in schizophrenic patients. I
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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