Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia
- Registration Number
- NCT03304457
- Lead Sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- All treatment naive patients clinically diagnosed first episode of SCZ according to ICD-10
- Patients of either sex with age range 18-45 years
- Treatment naïve patients
- Other Psychotic spectrum disorders (F21- F29)
- Highly agitated/ violent/ suicidal patients who need immediate treatment
- Patients with comorbid substance abuse except Nicotine use or history of organicity
- Patients with known history of diabetes mellitus, hypertension or any long standing significant medical illness/ significant neurological impairment/ clinical observable mental retardation
- Pregnant and nursing women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine Olanzapine Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks Lurasidone Lurasidone Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks
- Primary Outcome Measures
Name Time Method Serum brain derived neurotrophic factor (BDNF) 6 weeks the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine
- Secondary Outcome Measures
Name Time Method serum nerve growth factor (NGF) 6 weeks the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine
Social and occupational functioning assessment scale (SOFAS) 6 weeks To determine the association (if any) between change in serum neurotrophic factor and SOFAS (Social and occupational functioning assessment scale) score
PANSS score 6 weeks To determine the association (if any) between change in serum neurotrophic factor and PANSS score
High Density Lipoprotein (HDL) 6 week to assess dyslipidemia
Serum Triglyceride 6 weeks to assess dyslipidemia
Glycosylated Hemoglobin (HbA1c) 6 weeks to assess dysglycemia
Very Low Density Lipoprotein (VLDL) 6 week to assess dyslipidemia
Serum Neurotrophin 3 (NT3) 6 weeks the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine
Serum Insulin 6 weeks to assess insulin resistance
Fasting blood sugar 6 weeks to assess dysglycemia
Low Density Lipoprotein (LDL) 6 week to assess dyslipidemia
LDL/HDL ratio 6 weeks to assess dyslipidemia and cardiovascular risk
Serum hsCRP 6 weeks to assess cardiovascular risk in schizophrenia
Trial Locations
- Locations (1)
AIIMS
🇮🇳Bhubaneshwar, Odisha, India