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

Sponsor

All India Institute of Medical Sciences, Bhubaneswar (Other)

Overall Status

Completed

CT.gov ID

NCT03304457

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Olanzapine Drug: Lurasidone	Phase 4

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.

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

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized, open label, active controlled studyA randomized, open label, active controlled study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in First Episode Untreated Schizophrenia: A Randomized, Open Label, Active Controlled Study

Actual Study Start Date :

Aug 25, 2017

Actual Primary Completion Date :

Mar 12, 2018

Actual Study Completion Date :

Mar 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Olanzapine Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks	Drug: Olanzapine Olanzapine 10mg once daily orally for 6 weeks
Experimental: Lurasidone Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks	Drug: Lurasidone Lurasidone 80mg once daily orally for 6 weeks

Arm

Intervention/Treatment

Active Comparator: Olanzapine

Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks

Drug: Olanzapine

Olanzapine 10mg once daily orally for 6 weeks

Experimental: Lurasidone

Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks

Drug: Lurasidone

Lurasidone 80mg once daily orally for 6 weeks

Outcome Measures

Primary Outcome Measures

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

serum nerve growth factor (NGF) [6 weeks]
the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine
Serum Neurotrophin 3 (NT3) [6 weeks]
the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine
PANSS score [6 weeks]
To determine the association (if any) between change in serum neurotrophic factor and PANSS score
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
Serum hsCRP [6 weeks]
to assess cardiovascular risk in schizophrenia
Serum Insulin [6 weeks]
to assess insulin resistance
LDL/HDL ratio [6 weeks]
to assess dyslipidemia and cardiovascular risk
Fasting blood sugar [6 weeks]
to assess dysglycemia
Glycosylated Hemoglobin (HbA1c) [6 weeks]
to assess dysglycemia
High Density Lipoprotein (HDL) [6 week]
to assess dyslipidemia
Low Density Lipoprotein (LDL) [6 week]
to assess dyslipidemia
Very Low Density Lipoprotein (VLDL) [6 week]
to assess dyslipidemia
Serum Triglyceride [6 weeks]
to assess dyslipidemia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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