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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Olanzapine
Lurasidone
Sponsored by
All India Institute of Medical Sciences, Bhubaneswar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Lurasidone, Olanzapine, Brain derived neurotrophic factor, Nerve growth factor, Neurotrophin 3

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • AIIMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Olanzapine

Lurasidone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum brain derived neurotrophic factor (BDNF)
the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2017
Last Updated
March 28, 2020
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
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1. Study Identification

Unique Protocol Identification Number
NCT03304457
Brief Title
Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Bhubaneswar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Lurasidone, Olanzapine, Brain derived neurotrophic factor, Nerve growth factor, Neurotrophin 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized, open label, active controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Description
Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks
Arm Title
Lurasidone
Arm Type
Experimental
Arm Description
Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Olanzapine 10mg once daily orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Intervention Description
Lurasidone 80mg once daily orally for 6 weeks
Primary Outcome Measure Information:
Title
Serum brain derived neurotrophic factor (BDNF)
Description
the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
serum nerve growth factor (NGF)
Description
the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine
Time Frame
6 weeks
Title
Serum Neurotrophin 3 (NT3)
Description
the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine
Time Frame
6 weeks
Title
PANSS score
Description
To determine the association (if any) between change in serum neurotrophic factor and PANSS score
Time Frame
6 weeks
Title
Social and occupational functioning assessment scale (SOFAS)
Description
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
Title
Serum hsCRP
Description
to assess cardiovascular risk in schizophrenia
Time Frame
6 weeks
Title
Serum Insulin
Description
to assess insulin resistance
Time Frame
6 weeks
Title
LDL/HDL ratio
Description
to assess dyslipidemia and cardiovascular risk
Time Frame
6 weeks
Title
Fasting blood sugar
Description
to assess dysglycemia
Time Frame
6 weeks
Title
Glycosylated Hemoglobin (HbA1c)
Description
to assess dysglycemia
Time Frame
6 weeks
Title
High Density Lipoprotein (HDL)
Description
to assess dyslipidemia
Time Frame
6 week
Title
Low Density Lipoprotein (LDL)
Description
to assess dyslipidemia
Time Frame
6 week
Title
Very Low Density Lipoprotein (VLDL)
Description
to assess dyslipidemia
Time Frame
6 week
Title
Serum Triglyceride
Description
to assess dyslipidemia
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debasish Hota, MD, DM
Organizational Affiliation
Professor & Head
Official's Role
Study Director
Facility Information:
Facility Name
AIIMS
City
Bhubaneshwar
State/Province
Odisha
ZIP/Postal Code
751019
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
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Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia

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