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Completed

NCT Number: NCT03304457

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

Olanzapine 10mg once daily orally for 6 weeks

Lurasidone

Drug

Lurasidone 80mg once daily orally for 6 weeks

Primary outcomes

  1. 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

  1. serum nerve growth factor (NGF)

    Time frame: 6 weeks

    the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine

  2. Serum Neurotrophin 3 (NT3)

    Time frame: 6 weeks

    the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine

  3. PANSS score

    Time frame: 6 weeks

    To determine the association (if any) between change in serum neurotrophic factor and PANSS score

  4. 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

  5. Serum hsCRP

    Time frame: 6 weeks

    to assess cardiovascular risk in schizophrenia

  6. Serum Insulin

    Time frame: 6 weeks

    to assess insulin resistance

  7. LDL/HDL ratio

    Time frame: 6 weeks

    to assess dyslipidemia and cardiovascular risk

  8. Fasting blood sugar

    Time frame: 6 weeks

    to assess dysglycemia

  9. Glycosylated Hemoglobin (HbA1c)

    Time frame: 6 weeks

    to assess dysglycemia

  10. High Density Lipoprotein (HDL)

    Time frame: 6 week

    to assess dyslipidemia

  11. Low Density Lipoprotein (LDL)

    Time frame: 6 week

    to assess dyslipidemia

  12. Very Low Density Lipoprotein (VLDL)

    Time frame: 6 week

    to assess dyslipidemia

  13. Serum Triglyceride

    Time frame: 6 weeks

    to assess dyslipidemia

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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