Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-26 @ 11:05 AM
Study NCT ID:
NCT03304457
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2017-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D000069056', 'term': 'Lurasidone Hydrochloride'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D054833', 'term': 'Isoindoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, open label, active controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-28', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-10-06', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum brain derived neurotrophic factor (BDNF)', 'timeFrame': '6 weeks', 'description': 'the change in serum level of BDNF from baseline after treatment with lurasidone or olanzapine'}], 'secondaryOutcomes': [{'measure': 'serum nerve growth factor (NGF)', 'timeFrame': '6 weeks', 'description': 'the change in serum level of NGF from baseline after treatment with lurasidone or olanzapine'}, {'measure': 'Serum Neurotrophin 3 (NT3)', 'timeFrame': '6 weeks', 'description': 'the change in serum level of NT3 from baseline after treatment with lurasidone or olanzapine'}, {'measure': 'PANSS score', 'timeFrame': '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)', 'timeFrame': '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', 'timeFrame': '6 weeks', 'description': 'to assess cardiovascular risk in schizophrenia'}, {'measure': 'Serum Insulin', 'timeFrame': '6 weeks', 'description': 'to assess insulin resistance'}, {'measure': 'LDL/HDL ratio', 'timeFrame': '6 weeks', 'description': 'to assess dyslipidemia and cardiovascular risk'}, {'measure': 'Fasting blood sugar', 'timeFrame': '6 weeks', 'description': 'to assess dysglycemia'}, {'measure': 'Glycosylated Hemoglobin (HbA1c)', 'timeFrame': '6 weeks', 'description': 'to assess dysglycemia'}, {'measure': 'High Density Lipoprotein (HDL)', 'timeFrame': '6 week', 'description': 'to assess dyslipidemia'}, {'measure': 'Low Density Lipoprotein (LDL)', 'timeFrame': '6 week', 'description': 'to assess dyslipidemia'}, {'measure': 'Very Low Density Lipoprotein (VLDL)', 'timeFrame': '6 week', 'description': 'to assess dyslipidemia'}, {'measure': 'Serum Triglyceride', 'timeFrame': '6 weeks', 'description': 'to assess dyslipidemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lurasidone', 'Olanzapine', 'Brain derived neurotrophic factor', 'Nerve growth factor', 'Neurotrophin 3'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '18791076', 'type': 'RESULT', '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': '21639796', 'type': 'RESULT', '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': '21357874', 'type': 'RESULT', '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': '11383973', 'type': 'RESULT', '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': '17006758', 'type': 'RESULT', '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': '16829550', 'type': 'RESULT', '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': '25681004', 'type': 'RESULT', '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': '20218790', 'type': 'RESULT', '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': '17459549', 'type': 'RESULT', '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': '17159456', 'type': 'RESULT', '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': '24595507', 'type': 'RESULT', '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.'}, {'pmid': '20568658', 'type': 'RESULT', '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.'}, {'pmid': '32740676', 'type': 'DERIVED', 'citation': 'Jena M, Mishra A, Mishra BR, Nath S, Maiti R. Effect of lurasidone versus olanzapine on cardiometabolic parameters in unmedicated patients with schizophrenia: a randomized controlled trial. Psychopharmacology (Berl). 2020 Nov;237(11):3471-3480. doi: 10.1007/s00213-020-05628-3. Epub 2020 Aug 1.'}, {'pmid': '30782512', 'type': 'DERIVED', 'citation': 'Jena M, Ranjan R, Mishra BR, Mishra A, Nath S, Sahu P, Meher BR, Srinivasan A, Maiti R. Effect of lurasidone vs olanzapine on neurotrophic biomarkers in unmedicated schizophrenia: A randomized controlled trial. J Psychiatr Res. 2019 May;112:1-6. doi: 10.1016/j.jpsychires.2019.02.007. Epub 2019 Feb 12.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nLurasidone 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.', 'detailedDescription': '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.\n\nLurasidone 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.\n\nMost 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All treatment naive patients clinically diagnosed first episode of SCZ according to ICD-10\n* Patients of either sex with age range 18-45 years\n* Treatment naïve patients\n\nExclusion Criteria:\n\n* Other Psychotic spectrum disorders (F21- F29)\n* Highly agitated/ violent/ suicidal patients who need immediate treatment\n* Patients with comorbid substance abuse except Nicotine use or history of organicity\n* Patients with known history of diabetes mellitus, hypertension or any long standing significant medical illness/ significant neurological impairment/ clinical observable mental retardation\n* Pregnant and nursing women'}, 'identificationModule': {'nctId': 'NCT03304457', 'briefTitle': 'Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences, Bhubaneswar'}, 'officialTitle': 'Effect of Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in First Episode Untreated Schizophrenia: A Randomized, Open Label, Active Controlled Study', 'orgStudyIdInfo': {'id': 'T/IM-F/17-18/29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Olanzapine', 'description': 'Olanzapine will be prescribed at a dose of 10mg once daily orally for 6 weeks', 'interventionNames': ['Drug: Olanzapine']}, {'type': 'EXPERIMENTAL', 'label': 'Lurasidone', 'description': 'Lurasidone will be prescribed at a dose of 80mg/day once daily orally for 6 weeks', 'interventionNames': ['Drug: Lurasidone']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'description': 'Olanzapine 10mg once daily orally for 6 weeks', 'armGroupLabels': ['Olanzapine']}, {'name': 'Lurasidone', 'type': 'DRUG', 'description': 'Lurasidone 80mg once daily orally for 6 weeks', 'armGroupLabels': ['Lurasidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751019', 'city': 'Bhubaneshwar', 'state': 'Odisha', 'country': 'India', 'facility': 'AIIMS'}], 'overallOfficials': [{'name': 'Debasish Hota, MD, DM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor & Head'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences, Bhubaneswar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Monalisa Jena, M.D.', 'investigatorAffiliation': 'All India Institute of Medical Sciences, Bhubaneswar'}}}}