Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia

• Status: Completed
• Trial end date: 2018-03-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Lurasidone Hydrochloride; Olanzapine

Criteria

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