Effect of Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in First Episode Untreated Schizophrenia: A Randomized, Open Label, Active Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Serum brain derived neurotrophic factor (BDNF)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Olanzapine
Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks
Intervention: Olanzapine (Drug)
Lurasidone
Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks
Intervention: Lurasidone (Drug)
Outcomes
Primary Outcomes
Serum brain derived neurotrophic factor (BDNF)
Time Frame: 6 weeks
the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine
Secondary Outcomes
- serum nerve growth factor (NGF)(6 weeks)
- Social and occupational functioning assessment scale (SOFAS)(6 weeks)
- PANSS score(6 weeks)
- High Density Lipoprotein (HDL)(6 week)
- Serum Triglyceride(6 weeks)
- Glycosylated Hemoglobin (HbA1c)(6 weeks)
- Very Low Density Lipoprotein (VLDL)(6 week)
- Serum Neurotrophin 3 (NT3)(6 weeks)
- Serum Insulin(6 weeks)
- Fasting blood sugar(6 weeks)
- Low Density Lipoprotein (LDL)(6 week)
- LDL/HDL ratio(6 weeks)
- Serum hsCRP(6 weeks)
Investigators
Dr. Monalisa Jena, M.D.
Assistant Professor
All India Institute of Medical Sciences, Bhubaneswar