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

March 28, 2020 updated by: Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneshwar, Odisha, India, 751019
        • AIIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Study Director: Debasish Hota, MD, DM, Professor & Head

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2017

Primary Completion (Actual)

March 12, 2018

Study Completion (Actual)

March 25, 2018

Study Registration Dates

First Submitted

October 3, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/IM-F/17-18/29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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