Nctid:
NCT06236451
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D028361", "term"=>"Mitochondrial Diseases"}, {"id"=>"D012559", "term"=>"Schizophrenia"}], "ancestors"=>[{"id"=>"D019967", "term"=>"Schizophrenia Spectrum and Other Psychotic Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}], "browseLeaves"=>[{"id"=>"M15376", "name"=>"Schizophrenia", "asFound"=>"Schizophrenia", "relevance"=>"HIGH"}, {"id"=>"M23341", "name"=>"Mitochondrial Diseases", "asFound"=>"Mitochondrial Dysfunction", "relevance"=>"HIGH"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M21838", "name"=>"Schizophrenia Spectrum and Other Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D018967", "term"=>"Risperidone"}, {"id"=>"D000068180", "term"=>"Aripiprazole"}], "ancestors"=>[{"id"=>"D012702", "term"=>"Serotonin Antagonists"}, {"id"=>"D018490", "term"=>"Serotonin Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D014150", "term"=>"Antipsychotic Agents"}, {"id"=>"D014149", "term"=>"Tranquilizing Agents"}, {"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D018492", "term"=>"Dopamine Antagonists"}, {"id"=>"D015259", "term"=>"Dopamine Agents"}, {"id"=>"D000928", "term"=>"Antidepressive Agents"}, {"id"=>"D018491", "term"=>"Dopamine Agonists"}, {"id"=>"D058825", "term"=>"Serotonin 5-HT1 Receptor Agonists"}, {"id"=>"D017366", "term"=>"Serotonin Receptor Agonists"}, {"id"=>"D058830", "term"=>"Serotonin 5-HT2 Receptor Antagonists"}, {"id"=>"D065127", "term"=>"Dopamine D2 Receptor Antagonists"}], "browseLeaves"=>[{"id"=>"M16904", "name"=>"Antipsychotic Agents", "relevance"=>"LOW"}, {"id"=>"M229", "name"=>"Aripiprazole", "asFound"=>"Reminders", "relevance"=>"HIGH"}, {"id"=>"M20999", "name"=>"Risperidone", "asFound"=>"Operation", "relevance"=>"HIGH"}, {"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M15513", "name"=>"Serotonin Antagonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M20596", "name"=>"Dopamine Antagonists", "relevance"=>"LOW"}, {"id"=>"M17962", "name"=>"Dopamine Agents", "relevance"=>"LOW"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M20595", "name"=>"Dopamine Agonists", "relevance"=>"LOW"}, {"id"=>"M29240", "name"=>"Serotonin 5-HT1 Receptor Agonists", "relevance"=>"LOW"}, {"id"=>"M19648", "name"=>"Serotonin Receptor Agonists", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-12", "completionDateStruct"=>{"date"=>"2025-11-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-12-17", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-19", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in Mitochondrial respiratory chain complex I activity", "timeFrame"=>"12 weeks", "description"=>"Mitochondrial respiratory chain complex I activity will be measured in platelets using a commercially available ELISA (enzyme-linked immunosorbent assay) kit at baseline and at 12 weeks of follow-up."}], "secondaryOutcomes"=>[{"measure"=>"Change in Serum lactate", "timeFrame"=>"12 weeks", "description"=>"Serum lactate will be measured using spectrophotometry at baseline and at 12 weeks follow up"}, {"measure"=>"Change in Serum creatine kinase", "timeFrame"=>"12 weeks", "description"=>"Serum creatine kinase will be measured using autoanalyzer at baseline and at 12 weeks"}, {"measure"=>"Change in Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores", "timeFrame"=>"12 weeks", "description"=>"Newcastle Mitochondrial Disease Adult Scale (NMDAS) scoring of all patients will be assessed at baseline and at 12 weeks of follow-up. The NMDAS offers a range of 0 to 5 points for each question. The results from each of the first three sections' questions are added together to determine each section's score. The more severe the ailment, the higher the score."}, {"measure"=>"Change in Positive and Negative Syndrome Scale (PANSS) scores", "timeFrame"=>"12 weeks", "description"=>"Positive and Negative Syndrome Scale (PANSS) scoring will be done at baseline and at 12 weeks follow-up. Out of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. The more severe the ailment, the higher the score."}, {"measure"=>"Responder rate", "timeFrame"=>"12 weeks", "description"=>"A patient with a reduction of Positive and Negative Syndrome Scale (PANSS) scores by ≥50% from baseline will be considered a 'responder'.."}, {"measure"=>"Change in Serum pyruvate", "timeFrame"=>"12 weeks", "description"=>"Serum pyruvate will be measured using spectrophotometry at baseline and at 12 weeks follow up."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Schizophrenia", "Mitochondrial electron transport chain complex", "Aripiprazole", "Risperidone", "Mitochondrial dysfunction"], "conditions"=>["Schizophrenia"]}, "referencesModule"=>{"references"=>[{"pmid"=>"37528429", "type"=>"RESULT", "citation"=>"Hardy RE, Chung I, Yu Y, Loh SHY, Morone N, Soleilhavoup C, Travaglio M, Serreli R, Panman L, Cain K, Hirst J, Martins LM, MacFarlane M, Pryde KR. The antipsychotic medications aripiprazole, brexpiprazole and cariprazine are off-target respiratory chain complex I inhibitors. Biol Direct. 2023 Aug 1;18(1):43. doi: 10.1186/s13062-023-00375-9."}, {"pmid"=>"34365585", "type"=>"RESULT", "citation"=>"Luptak M, Fisar Z, Hroudova J. Effect of Novel Antipsychotics on Energy Metabolism - In Vitro Study in Pig Brain Mitochondria. Mol Neurobiol. 2021 Nov;58(11):5548-5563. doi: 10.1007/s12035-021-02498-4. Epub 2021 Aug 8."}, {"pmid"=>"14661862", "type"=>"RESULT", "citation"=>"Modica-Napolitano JS, Lagace CJ, Brennan WA, Aprille JR. Differential effects of typical and atypical neuroleptics on mitochondrial function in vitro. Arch Pharm Res. 2003 Nov;26(11):951-9. doi: 10.1007/BF02980205."}, {"pmid"=>"26953070", "type"=>"RESULT", "citation"=>"Scaini G, Rochi N, Morais MO, Maggi DD, De-Nes BT, Quevedo J, Streck EL. In vitro effect of antipsychotics on brain energy metabolism parameters in the brain of rats. Acta Neuropsychiatr. 2013 Feb;25(1):18-26. doi: 10.1111/j.1601-5215.2012.00650.x."}, {"pmid"=>"17502776", "type"=>"RESULT", "citation"=>"Casademont J, Garrabou G, Miro O, Lopez S, Pons A, Bernardo M, Cardellach F. Neuroleptic treatment effect on mitochondrial electron transport chain: peripheral blood mononuclear cells analysis in psychotic patients. J Clin Psychopharmacol. 2007 Jun;27(3):284-8. doi: 10.1097/JCP.0b013e318054753e."}, {"pmid"=>"25446950", "type"=>"RESULT", "citation"=>"Rajasekaran A, Venkatasubramanian G, Berk M, Debnath M. Mitochondrial dysfunction in schizophrenia: pathways, mechanisms and implications. Neurosci Biobehav Rev. 2015 Jan;48:10-21. doi: 10.1016/j.neubiorev.2014.11.005. Epub 2014 Nov 15."}, {"pmid"=>"37175697", "type"=>"RESULT", "citation"=>"Fizikova I, Dragasek J, Racay P. Mitochondrial Dysfunction, Altered Mitochondrial Oxygen, and Energy Metabolism Associated with the Pathogenesis of Schizophrenia. Int J Mol Sci. 2023 Apr 28;24(9):7991. doi: 10.3390/ijms24097991."}, {"pmid"=>"16801664", "type"=>"RESULT", "citation"=>"Schaefer AM, Phoenix C, Elson JL, McFarland R, Chinnery PF, Turnbull DM. Mitochondrial disease in adults: a scale to monitor progression and treatment. Neurology. 2006 Jun 27;66(12):1932-4. doi: 10.1212/01.wnl.0000219759.72195.41."}, {"pmid"=>"17287825", "type"=>"RESULT", "citation"=>"Leucht S, Davis JM, Engel RR, Kane JM, Wagenpfeil S. Defining 'response' in antipsychotic drug trials: recommendations for the use of scale-derived cutoffs. Neuropsychopharmacology. 2007 Sep;32(9):1903-10. doi: 10.1038/sj.npp.1301325. Epub 2007 Feb 7."}, {"pmid"=>"22215558", "type"=>"RESULT", "citation"=>"Venegas V, Halberg MC. Measurement of mitochondrial DNA copy number. Methods Mol Biol. 2012;837:327-35. doi: 10.1007/978-1-61779-504-6_22."}]}, "descriptionModule"=>{"briefSummary"=>"Schizophrenia is a serious mental disorder with a global prevalence of 1%. The main cause of this condition is dysfunction in the signaling of neurotransmitters dopamine, serotonin, glutamate and Gamma-aminobutyric acid .According to recent research, a disturbed cellular energy state caused by mitochondrial dysfunction is thought to be a factor in the development of schizophrenia.\n\nThe aim of the treatment of schizophrenia is to reduce symptoms and is mainly based on the monoamine hypothesis. Atypical antipsychotics are the first-line of treatment.\n\nCertain typical and atypical antipsychotic medications have been shown in prior preclinical research to decrease mitochondrial respiratory chain complex I activity. In contrast to individuals who were drug-naive, Casademont et al. found a significant decrease in complex I activity with haloperidol and risperidone in one cross-sectional observational study. Also, there is evidence suggesting that mitochondrial dysfunction is linked to the extrapyramidal side effects seen with antipsychotics.\n\nTo date, there are no randomized controlled trials that assess the effect of these drugs on mitochondrial functions. Hence, the present randomized controlled trial has been planned to evaluate and compare the clinical and biochemical markers of mitochondrial dysfunction in schizophrenia patients treated with the atypical antipsychotics risperidone and aripiprazole."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients meeting the DSM-5 criteria for diagnosis of schizophrenia.\n* Treatment naıv̈ e patients or patients who had not taken any antipsychotic drugs for at least 4 weeks before recruitment.\n* Patients of either sex between the ages of 18 and 60 years.\n* Legally authorized representative (LAR) of patients consenting to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Patients diagnosed with other psychiatric disorders including schizoaffective disorder or schizophrenia with somatoform disorders.\n* Highly agitated patients who need immediate indoor-based treatment.\n* Patients with known mitochondrial disorders (MELAS, LHON, Leigh syndrome, KearnsSayre syndrome, MERRF etc.)\n* Patients with history of comorbidities like cardiovascular, renal, hepatic, neurological, respiratory or endocrinal diseases or malignancies.\n* Patients with history of substance abuse.\n* Pregnant or lactating mothers."}, "identificationModule"=>{"nctId"=>"NCT06236451", "briefTitle"=>"Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia", "organization"=>{"class"=>"OTHER", "fullName"=>"All India Institute of Medical Sciences, Bhubaneswar"}, "officialTitle"=>"A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia", "orgStudyIdInfo"=>{"id"=>"PGThesis/2023-24/100"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Aripiprazole group", "description"=>"Aripiprazole will be started at dose of 10 mg/day and increased to a stable dose of 20 mg/day over 2-3 weeks and will be continued till 12 weeks.", "interventionNames"=>["Drug: Aripiprazole"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Risperidone group", "description"=>"Risperidone will be started at dose of 2 mg/day and increased to a stable dose of 6 mg/day over 2-3 weeks and continued till 12 weeks.", "interventionNames"=>["Drug: Risperidone"]}], "interventions"=>[{"name"=>"Aripiprazole", "type"=>"DRUG", "description"=>"Aripiprazole will be started at dose of 10 mg/day and increased to a stable dose of 20 mg/day over 2-3 weeks and will be continued till 12 weeks.", "armGroupLabels"=>["Aripiprazole group"]}, {"name"=>"Risperidone", "type"=>"DRUG", "description"=>"Risperidone will be started at dose of 2 mg/day and increased to a stable dose of 6 mg/day over 2-3 weeks and continued till 12 weeks.", "armGroupLabels"=>["Risperidone group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"751019", "city"=>"Bhubaneswar", "state"=>"Odisha", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"RITUPARNA MAITI, MD", "role"=>"CONTACT", "email"=>"rituparnamaiti@gmail.com", "phone"=>"9438884191"}, {"name"=>"BISWA R MISHRA, MD", "role"=>"CONTACT", "email"=>"brm1678@gmail.com"}], "facility"=>"All India Institute of Medical Sciences (AIIMS)", "geoPoint"=>{"lat"=>20.27241, "lon"=>85.83385}}], "centralContacts"=>[{"name"=>"Rituparna Maiti, MD", "role"=>"CONTACT", "email"=>"pharm_rituparna@aiimsbhubaneswar.edu.in", "phone"=>"9438884191"}, {"name"=>"Biswa Ranjan Mishra, MD", "role"=>"CONTACT", "email"=>"psych_biswa@aiimsbhubaneswar.edu.in", "phone"=>"9438884220"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"All India Institute of Medical Sciences, Bhubaneswar", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"RITUPARNA MAITI", "investigatorAffiliation"=>"All India Institute of Medical Sciences, Bhubaneswar"}}}}
