AIIMS
Bhubaneswar, Odisha, 751019, India
NCT Number: NCT03304457
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 4
Bhubaneswar, Odisha, 751019, India
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Olanzapine 10mg once daily orally for 6 weeks
Lurasidone 80mg once daily orally for 6 weeks
Time frame: 6 weeks
the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine
Time frame: 6 weeks
the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine
Time frame: 6 weeks
the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine
Time frame: 6 weeks
To determine the association (if any) between change in serum neurotrophic factor and PANSS score
Time frame: 6 weeks
To determine the association (if any) between change in serum neurotrophic factor and SOFAS (Social and occupational functioning assessment scale) score
Time frame: 6 weeks
to assess cardiovascular risk in schizophrenia
Time frame: 6 weeks
to assess insulin resistance
Time frame: 6 weeks
to assess dyslipidemia and cardiovascular risk
Time frame: 6 weeks
to assess dysglycemia
Time frame: 6 weeks
to assess dysglycemia
Time frame: 6 week
to assess dyslipidemia
Time frame: 6 week
to assess dyslipidemia
Time frame: 6 week
to assess dyslipidemia
Time frame: 6 weeks
to assess dyslipidemia
All India Institute of Medical Sciences, Bhubaneswar
Other
Effect of Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in First Episode Untreated Schizophrenia: A Randomized, Open Label, Active Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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