Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Olanzapine; Lurasidone
Intervention type(s): Drug; Drug
Intervention description(s): Olanzapine 10mg once daily orally for 6 weeks; Lurasidone 80mg once daily orally for 6 weeks
Intervention MeSH terms: Olanzapine; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, open label, active controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lurasidone; Olanzapine; Brain derived neurotrophic factor; Nerve growth factor; Neurotrophin 3