<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03304457</url>
  </required_header>
  <id_info>
    <org_study_id>T/IM-F/17-18/29</org_study_id>
    <nct_id>NCT03304457</nct_id>
  </id_info>
  <brief_title>Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, Bhubaneswar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, Bhubaneswar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schizophrenia (SCZ) is a chronic, severe and disabling mental disorder with unclear etiology&#xD;
      and pathophysiology concerned with neuro-developmental,neurodegenerative abnormalities and&#xD;
      cognitive impairmentslinked to behavioural changes.According to neurotrophic hypothesis, the&#xD;
      changes result due to the abnormal regulation of neurotrophic factor, especially the&#xD;
      decreased serum brain derived neurotrophic factor (BDNF) validated by several meta-analyses.&#xD;
      However, the regulation of nerve growth factor (NGF) in SCZ remains unclear because of the&#xD;
      inconsistent findings from the previous clinical studies.&#xD;
&#xD;
      Lurasidone is a novel antipsychotic drug approved for adult SCZ and for affective&#xD;
      symptomatology &amp; cognitive deficits. Principal advantages over some other second-generation&#xD;
      antipsychotics are its highly favourable metabolic profile and once daily dosing regimen.&#xD;
      Some of the studies indicate that risperidone, olanzapine, clozapine &amp; aripiprazole might not&#xD;
      alter BDNF levels, at least within 8 weeks of treatment.While other two studies with&#xD;
      olanzapine suggest that BDNF might influence the response to monotherapy in SCZ patients.All&#xD;
      these previous studies are non-conclusive &amp; contradictory to each other which draw our&#xD;
      attention for doing the research further to reach a conclusive result about the effect of&#xD;
      olanzapine and lurasidone on neurotrophic biomarkers in SCZ.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schizophrenia (SCZ) is a chronic, severe and disabling mental disorder with unclear aetiology&#xD;
      and pathophysiology concerned with neuro-developmental,neurodegenerative abnormalities and&#xD;
      cognitive impairments linked to behavioural changes.According to neurotrophic hypothesis, the&#xD;
      changes result due to the abnormal regulation of neurotrophic factor, especially the&#xD;
      decreased serum brain derived neurotrophic factor (BDNF) validated by several meta-analyses.&#xD;
      However, the regulation of nerve growth factor (NGF) in SCZ remains unclear because of the&#xD;
      inconsistent findings from the previous clinical studies.&#xD;
&#xD;
      Lurasidone is a novel antipsychotic drug approved for adult SCZ and for affective&#xD;
      symptomatology &amp; cognitive deficits. Principal advantages over some other second-generation&#xD;
      antipsychotics are its highly favourable metabolic profile and once daily dosing regimen.&#xD;
      Some of the studies indicate that risperidone, olanzapine, clozapine &amp; aripiprazole might not&#xD;
      alter BDNF levels, at least within 8 weeks of treatment.While other two studies with&#xD;
      olanzapine suggest that BDNF might influence the response to monotherapy in SCZ patients.All&#xD;
      these previous studies are non-conclusive &amp; contradictory to each other which draw our&#xD;
      attention for doing the research further to reach a conclusive result about the effect of&#xD;
      olanzapine and lurasidone on neurotrophic biomarkers in SCZ.&#xD;
&#xD;
      Most of the antipsychotic drugs prescribed for SCZ are based on the dopamine hypothesis. In&#xD;
      recent times, neurotrophic hypothesis gained importance in the pathophysiology of SCZ. So,&#xD;
      our study may enable psychiatrist to choose a better antipsychotic drug having effect on both&#xD;
      dopamine as well as neurotrophic factors. Previously there were no studies on effect of&#xD;
      lurasidone on neurotrophic factors in SCZ &amp; also there was no head-on comparison of&#xD;
      lurasidone and olanzapine&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Actual">March 25, 2018</completion_date>
  <primary_completion_date type="Actual">March 12, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A randomized, open label, active controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum brain derived neurotrophic factor (BDNF)</measure>
    <time_frame>6 weeks</time_frame>
    <description>the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum nerve growth factor (NGF)</measure>
    <time_frame>6 weeks</time_frame>
    <description>the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Neurotrophin 3 (NT3)</measure>
    <time_frame>6 weeks</time_frame>
    <description>the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PANSS score</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine the association (if any) between change in serum neurotrophic factor and PANSS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social and occupational functioning assessment scale (SOFAS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine the association (if any) between change in serum neurotrophic factor and SOFAS (Social and occupational functioning assessment scale) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum hsCRP</measure>
    <time_frame>6 weeks</time_frame>
    <description>to assess cardiovascular risk in schizophrenia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Insulin</measure>
    <time_frame>6 weeks</time_frame>
    <description>to assess insulin resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL/HDL ratio</measure>
    <time_frame>6 weeks</time_frame>
    <description>to assess dyslipidemia and cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood sugar</measure>
    <time_frame>6 weeks</time_frame>
    <description>to assess dysglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycosylated Hemoglobin (HbA1c)</measure>
    <time_frame>6 weeks</time_frame>
    <description>to assess dysglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Density Lipoprotein (HDL)</measure>
    <time_frame>6 week</time_frame>
    <description>to assess dyslipidemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low Density Lipoprotein (LDL)</measure>
    <time_frame>6 week</time_frame>
    <description>to assess dyslipidemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Very Low Density Lipoprotein (VLDL)</measure>
    <time_frame>6 week</time_frame>
    <description>to assess dyslipidemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Triglyceride</measure>
    <time_frame>6 weeks</time_frame>
    <description>to assess dyslipidemia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Olanzapine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lurasidone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olanzapine</intervention_name>
    <description>Olanzapine 10mg once daily orally for 6 weeks</description>
    <arm_group_label>Olanzapine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lurasidone</intervention_name>
    <description>Lurasidone 80mg once daily orally for 6 weeks</description>
    <arm_group_label>Lurasidone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All treatment naive patients clinically diagnosed first episode of SCZ according to&#xD;
             ICD-10&#xD;
&#xD;
          -  Patients of either sex with age range 18-45 years&#xD;
&#xD;
          -  Treatment naïve patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other Psychotic spectrum disorders (F21- F29)&#xD;
&#xD;
          -  Highly agitated/ violent/ suicidal patients who need immediate treatment&#xD;
&#xD;
          -  Patients with comorbid substance abuse except Nicotine use or history of organicity&#xD;
&#xD;
          -  Patients with known history of diabetes mellitus, hypertension or any long standing&#xD;
             significant medical illness/ significant neurological impairment/ clinical observable&#xD;
             mental retardation&#xD;
&#xD;
          -  Pregnant and nursing women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Debasish Hota, MD, DM</last_name>
    <role>Study Director</role>
    <affiliation>Professor &amp; Head</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AIIMS</name>
      <address>
        <city>Bhubaneshwar</city>
        <state>Odisha</state>
        <zip>751019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <results_reference>
    <citation>van Os J, Rutten BP, Poulton R. Gene-environment interactions in schizophrenia: review of epidemiological findings and future directions. Schizophr Bull. 2008 Nov;34(6):1066-82. doi: 10.1093/schbul/sbn117. Epub 2008 Sep 12.</citation>
    <PMID>18791076</PMID>
  </results_reference>
  <results_reference>
    <citation>Gejman PV, Sanders AR, Kendler KS. Genetics of schizophrenia: new findings and challenges. Annu Rev Genomics Hum Genet. 2011;12:121-44. doi: 10.1146/annurev-genom-082410-101459.</citation>
    <PMID>21639796</PMID>
  </results_reference>
  <results_reference>
    <citation>Owen MJ, O'Donovan MC, Thapar A, Craddock N. Neurodevelopmental hypothesis of schizophrenia. Br J Psychiatry. 2011 Mar;198(3):173-5. doi: 10.1192/bjp.bp.110.084384.</citation>
    <PMID>21357874</PMID>
  </results_reference>
  <results_reference>
    <citation>Ashe PC, Berry MD, Boulton AA. Schizophrenia, a neurodegenerative disorder with neurodevelopmental antecedents. Prog Neuropsychopharmacol Biol Psychiatry. 2001 May;25(4):691-707. doi: 10.1016/s0278-5846(01)00159-2.</citation>
    <PMID>11383973</PMID>
  </results_reference>
  <results_reference>
    <citation>Perez-Neri I, Ramirez-Bermudez J, Montes S, Rios C. Possible mechanisms of neurodegeneration in schizophrenia. Neurochem Res. 2006 Oct;31(10):1279-94. doi: 10.1007/s11064-006-9162-3. Epub 2006 Sep 28.</citation>
    <PMID>17006758</PMID>
  </results_reference>
  <results_reference>
    <citation>Matza LS, Buchanan R, Purdon S, Brewster-Jordan J, Zhao Y, Revicki DA. Measuring changes in functional status among patients with schizophrenia: the link with cognitive impairment. Schizophr Bull. 2006 Oct;32(4):666-78. doi: 10.1093/schbul/sbl004. Epub 2006 Jul 7.</citation>
    <PMID>16829550</PMID>
  </results_reference>
  <results_reference>
    <citation>Ahmed AO, Mantini AM, Fridberg DJ, Buckley PF. Brain-derived neurotrophic factor (BDNF) and neurocognitive deficits in people with schizophrenia: a meta-analysis. Psychiatry Res. 2015 Mar 30;226(1):1-13. doi: 10.1016/j.psychres.2014.12.069. Epub 2015 Jan 28.</citation>
    <PMID>25681004</PMID>
  </results_reference>
  <results_reference>
    <citation>Yoshimura R, Ueda N, Hori H, Ikenouchi-Sugita A, Umene-Nakano W, Nakamura J. Different patterns of longitudinal changes in plasma levels of catecholamine metabolites and brain-derived neurotrophic factor after administration of atypical antipsychotics in first episode untreated schizophrenic patients. World J Biol Psychiatry. 2010 Mar;11(2 Pt 2):256-61. doi: 10.3109/15622970802309617.</citation>
    <PMID>20218790</PMID>
  </results_reference>
  <results_reference>
    <citation>Yoshimura R, Hori H, Sugita A, Ueda N, Kakihara S, Umene W, Nakano Y, Shinkai K, Mitoma M, Ohta M, Shinkai T, Nakamura J. Treatment with risperidone for 4 weeks increased plasma 3-methoxy-4-hydroxypnenylglycol (MHPG) levels, but did not alter plasma brain-derived neurotrophic factor (BDNF) levels in schizophrenic patients. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jun 30;31(5):1072-7. doi: 10.1016/j.pnpbp.2007.03.010. Epub 2007 Mar 24.</citation>
    <PMID>17459549</PMID>
  </results_reference>
  <results_reference>
    <citation>Hori H, Yoshimura R, Yamada Y, Ikenouchi A, Mitoma M, Ida Y, Nakamura J. Effects of olanzapine on plasma levels of catecholamine metabolites, cytokines, and brain-derived neurotrophic factor in schizophrenic patients. Int Clin Psychopharmacol. 2007 Jan;22(1):21-7. doi: 10.1097/YIC.0b013e3280103593.</citation>
    <PMID>17159456</PMID>
  </results_reference>
  <results_reference>
    <citation>Nikolac Perkovic M, Nedic Erjavec G, Zivkovic M, Sagud M, Uzun S, Mihaljevic-Peles A, Kozumplik O, Muck-Seler D, Pivac N. Association between the brain-derived neurotrophic factor Val66Met polymorphism and therapeutic response to olanzapine in schizophrenia patients. Psychopharmacology (Berl). 2014 Sep;231(18):3757-64. doi: 10.1007/s00213-014-3515-4. Epub 2014 Mar 5.</citation>
    <PMID>24595507</PMID>
  </results_reference>
  <results_reference>
    <citation>Gonzalez-Pinto A, Mosquera F, Palomino A, Alberich S, Gutierrez A, Haidar K, Vega P, Barbeito S, Ortiz A, Matute C. Increase in brain-derived neurotrophic factor in first episode psychotic patients after treatment with atypical antipsychotics. Int Clin Psychopharmacol. 2010 Jul;25(4):241-5. doi: 10.1097/yic.0b013e328338bc5a.</citation>
    <PMID>20568658</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 28, 2020</last_update_submitted>
  <last_update_submitted_qc>March 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, Bhubaneswar</investigator_affiliation>
    <investigator_full_name>Dr. Monalisa Jena, M.D.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Lurasidone</keyword>
  <keyword>Olanzapine</keyword>
  <keyword>Brain derived neurotrophic factor</keyword>
  <keyword>Nerve growth factor</keyword>
  <keyword>Neurotrophin 3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olanzapine</mesh_term>
    <mesh_term>Lurasidone Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03304457
org study id: T/IM-F/17-18/29
nct id: NCT03304457
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized, open label, active controlled study
primary purpose: Treatment
masking: None (Open Label)
measure: Serum brain derived neurotrophic factor (BDNF)
time frame: 6 weeks
description: the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine
measure: serum nerve growth factor (NGF)
time frame: 6 weeks
description: the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine
measure: Serum Neurotrophin 3 (NT3)
time frame: 6 weeks
description: the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine
measure: PANSS score
time frame: 6 weeks
description: To determine the association (if any) between change in serum neurotrophic factor and PANSS score
measure: Social and occupational functioning assessment scale (SOFAS)
time frame: 6 weeks
description: To determine the association (if any) between change in serum neurotrophic factor and SOFAS (Social and occupational functioning assessment scale) score
measure: Serum hsCRP
time frame: 6 weeks
description: to assess cardiovascular risk in schizophrenia
measure: Serum Insulin
time frame: 6 weeks
description: to assess insulin resistance
measure: LDL/HDL ratio
time frame: 6 weeks
description: to assess dyslipidemia and cardiovascular risk
measure: Fasting blood sugar
time frame: 6 weeks
description: to assess dysglycemia
measure: Glycosylated Hemoglobin (HbA1c)
time frame: 6 weeks
description: to assess dysglycemia
measure: High Density Lipoprotein (HDL)
time frame: 6 week
description: to assess dyslipidemia
measure: Low Density Lipoprotein (LDL)
time frame: 6 week
description: to assess dyslipidemia
measure: Very Low Density Lipoprotein (VLDL)
time frame: 6 week
description: to assess dyslipidemia
measure: Serum Triglyceride
time frame: 6 weeks
description: to assess dyslipidemia
arm group label: Olanzapine
arm group type: Active Comparator
description: Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks
arm group label: Lurasidone
arm group type: Experimental
description: Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks
intervention type: Drug
intervention name: Olanzapine
description: Olanzapine 10mg once daily orally for 6 weeks
arm group label: Olanzapine
intervention type: Drug
intervention name: Lurasidone
description: Lurasidone 80mg once daily orally for 6 weeks
arm group label: Lurasidone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Debasish Hota, MD, DM
role: Study Director
affiliation: Professor & Head
facility: 
country: India
citation: van Os J, Rutten BP, Poulton R. Gene-environment interactions in schizophrenia: review of epidemiological findings and future directions. Schizophr Bull. 2008 Nov;34(6):1066-82. doi: 10.1093/schbul/sbn117. Epub 2008 Sep 12.
PMID: 18791076
citation: Gejman PV, Sanders AR, Kendler KS. Genetics of schizophrenia: new findings and challenges. Annu Rev Genomics Hum Genet. 2011;12:121-44. doi: 10.1146/annurev-genom-082410-101459.
PMID: 21639796
citation: Owen MJ, O'Donovan MC, Thapar A, Craddock N. Neurodevelopmental hypothesis of schizophrenia. Br J Psychiatry. 2011 Mar;198(3):173-5. doi: 10.1192/bjp.bp.110.084384.
PMID: 21357874
citation: Ashe PC, Berry MD, Boulton AA. Schizophrenia, a neurodegenerative disorder with neurodevelopmental antecedents. Prog Neuropsychopharmacol Biol Psychiatry. 2001 May;25(4):691-707. doi: 10.1016/s0278-5846(01)00159-2.
PMID: 11383973
citation: Perez-Neri I, Ramirez-Bermudez J, Montes S, Rios C. Possible mechanisms of neurodegeneration in schizophrenia. Neurochem Res. 2006 Oct;31(10):1279-94. doi: 10.1007/s11064-006-9162-3. Epub 2006 Sep 28.
PMID: 17006758
citation: Matza LS, Buchanan R, Purdon S, Brewster-Jordan J, Zhao Y, Revicki DA. Measuring changes in functional status among patients with schizophrenia: the link with cognitive impairment. Schizophr Bull. 2006 Oct;32(4):666-78. doi: 10.1093/schbul/sbl004. Epub 2006 Jul 7.
PMID: 16829550
citation: Ahmed AO, Mantini AM, Fridberg DJ, Buckley PF. Brain-derived neurotrophic factor (BDNF) and neurocognitive deficits in people with schizophrenia: a meta-analysis. Psychiatry Res. 2015 Mar 30;226(1):1-13. doi: 10.1016/j.psychres.2014.12.069. Epub 2015 Jan 28.
PMID: 25681004
citation: Yoshimura R, Ueda N, Hori H, Ikenouchi-Sugita A, Umene-Nakano W, Nakamura J. Different patterns of longitudinal changes in plasma levels of catecholamine metabolites and brain-derived neurotrophic factor after administration of atypical antipsychotics in first episode untreated schizophrenic patients. World J Biol Psychiatry. 2010 Mar;11(2 Pt 2):256-61. doi: 10.3109/15622970802309617.
PMID: 20218790
citation: Yoshimura R, Hori H, Sugita A, Ueda N, Kakihara S, Umene W, Nakano Y, Shinkai K, Mitoma M, Ohta M, Shinkai T, Nakamura J. Treatment with risperidone for 4 weeks increased plasma 3-methoxy-4-hydroxypnenylglycol (MHPG) levels, but did not alter plasma brain-derived neurotrophic factor (BDNF) levels in schizophrenic patients. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jun 30;31(5):1072-7. doi: 10.1016/j.pnpbp.2007.03.010. Epub 2007 Mar 24.
PMID: 17459549
citation: Hori H, Yoshimura R, Yamada Y, Ikenouchi A, Mitoma M, Ida Y, Nakamura J. Effects of olanzapine on plasma levels of catecholamine metabolites, cytokines, and brain-derived neurotrophic factor in schizophrenic patients. Int Clin Psychopharmacol. 2007 Jan;22(1):21-7. doi: 10.1097/YIC.0b013e3280103593.
PMID: 17159456
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responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, Bhubaneswar
investigator full name: Dr. Monalisa Jena, M.D.
investigator title: Assistant Professor
mesh term: Schizophrenia
mesh term: Olanzapine
mesh term: Lurasidone Hydrochloride
sharing ipd: No