Clinical trial NCT03304457: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Lurasidone
Olanzapine
Brain derived neurotrophic factor
Nerve growth factor
Neurotrophin 3
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, open label, active controlled study
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Serum brain derived neurotrophic factor (BDNF)
timeFrame: 6 weeks
Secondary outcomes:
measure: serum nerve growth factor (NGF)
timeFrame: 6 weeks
measure: Serum Neurotrophin 3 (NT3)
timeFrame: 6 weeks
measure: PANSS score
timeFrame: 6 weeks
measure: Social and occupational functioning assessment scale (SOFAS)
timeFrame: 6 weeks
measure: Serum hsCRP
timeFrame: 6 weeks
measure: Serum Insulin
timeFrame: 6 weeks
measure: LDL/HDL ratio
timeFrame: 6 weeks
measure: Fasting blood sugar
timeFrame: 6 weeks
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: 6 weeks
measure: High Density Lipoprotein (HDL)
timeFrame: 6 week
measure: Low Density Lipoprotein (LDL)
timeFrame: 6 week
measure: Very Low Density Lipoprotein (VLDL)
timeFrame: 6 week
measure: Serum Triglyceride
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bhubaneshwar
country: India
facility: AIIMS
state: Odisha
Study officials:
affiliation: Professor & Head
name: Debasish Hota, MD, DM
role: STUDY_DIRECTOR
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