A Phase 4 interventional study of Olanzapine and Lurasidone in Schizophrenia, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Completed at 1 site in India. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Phase 4, Interventional, and Treatment
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
Exclusion Criteria:
Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks
Drug: Olanzapine
Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks
Drug: Lurasidone
Olanzapine 10mg once daily orally for 6 weeks
Lurasidone 80mg once daily orally for 6 weeks
Serum brain derived neurotrophic factor (BDNF)
the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine
Time frame: 6 weeks
serum nerve growth factor (NGF)
the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine
Time frame: 6 weeks
Serum Neurotrophin 3 (NT3)
the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine
Time frame: 6 weeks
PANSS score
To determine the association (if any) between change in serum neurotrophic factor and PANSS score
Time frame: 6 weeks
Social and occupational functioning assessment scale (SOFAS)
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
Serum hsCRP
to assess cardiovascular risk in schizophrenia
Time frame: 6 weeks
Serum Insulin
to assess insulin resistance
Time frame: 6 weeks
LDL/HDL ratio
to assess dyslipidemia and cardiovascular risk
Time frame: 6 weeks
Fasting blood sugar
to assess dysglycemia
Time frame: 6 weeks
Glycosylated Hemoglobin (HbA1c)
to assess dysglycemia
Time frame: 6 weeks
High Density Lipoprotein (HDL)
to assess dyslipidemia
Time frame: 6 week
Low Density Lipoprotein (LDL)
to assess dyslipidemia
Time frame: 6 week
Very Low Density Lipoprotein (VLDL)
to assess dyslipidemia
Time frame: 6 week
Serum Triglyceride
to assess dyslipidemia
Time frame: 6 weeks
Plan to share: No
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All India Institute of Medical Sciences, Bhubaneswar