Schizophrenia Clinical Trial
Official title:
Effect of Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in First Episode Untreated Schizophrenia: A Randomized, Open Label, Active Controlled Study
Schizophrenia (SCZ) is a chronic, severe and disabling mental disorder with unclear etiology
and pathophysiology concerned with neuro-developmental,neurodegenerative abnormalities and
cognitive impairmentslinked to behavioural changes.According to neurotrophic hypothesis, the
changes result due to the abnormal regulation of neurotrophic factor, especially the
decreased serum brain derived neurotrophic factor (BDNF) validated by several meta-analyses.
However, the regulation of nerve growth factor (NGF) in SCZ remains unclear because of the
inconsistent findings from the previous clinical studies.
Lurasidone is a novel antipsychotic drug approved for adult SCZ and for affective
symptomatology & cognitive deficits. Principal advantages over some other second-generation
antipsychotics are its highly favourable metabolic profile and once daily dosing regimen.
Some of the studies indicate that risperidone, olanzapine, clozapine & aripiprazole might not
alter BDNF levels, at least within 8 weeks of treatment.While other two studies with
olanzapine suggest that BDNF might influence the response to monotherapy in SCZ patients.All
these previous studies are non-conclusive & contradictory to each other which draw our
attention for doing the research further to reach a conclusive result about the effect of
olanzapine and lurasidone on neurotrophic biomarkers in SCZ.
Schizophrenia (SCZ) is a chronic, severe and disabling mental disorder with unclear aetiology
and pathophysiology concerned with neuro-developmental,neurodegenerative abnormalities and
cognitive impairments linked to behavioural changes.According to neurotrophic hypothesis, the
changes result due to the abnormal regulation of neurotrophic factor, especially the
decreased serum brain derived neurotrophic factor (BDNF) validated by several meta-analyses.
However, the regulation of nerve growth factor (NGF) in SCZ remains unclear because of the
inconsistent findings from the previous clinical studies.
Lurasidone is a novel antipsychotic drug approved for adult SCZ and for affective
symptomatology & cognitive deficits. Principal advantages over some other second-generation
antipsychotics are its highly favourable metabolic profile and once daily dosing regimen.
Some of the studies indicate that risperidone, olanzapine, clozapine & aripiprazole might not
alter BDNF levels, at least within 8 weeks of treatment.While other two studies with
olanzapine suggest that BDNF might influence the response to monotherapy in SCZ patients.All
these previous studies are non-conclusive & contradictory to each other which draw our
attention for doing the research further to reach a conclusive result about the effect of
olanzapine and lurasidone on neurotrophic biomarkers in SCZ.
Most of the antipsychotic drugs prescribed for SCZ are based on the dopamine hypothesis. In
recent times, neurotrophic hypothesis gained importance in the pathophysiology of SCZ. So,
our study may enable psychiatrist to choose a better antipsychotic drug having effect on both
dopamine as well as neurotrophic factors. Previously there were no studies on effect of
lurasidone on neurotrophic factors in SCZ & also there was no head-on comparison of
lurasidone and olanzapine
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