Nctid:
NCT06229977
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003863", "term"=>"Depression"}, {"id"=>"D000003866", "term"=>"Depressive Disorder"}, {"id"=>"D000001714", "term"=>"Bipolar Disorder"}], "ancestors"=>[{"id"=>"D000001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D000019964", "term"=>"Mood Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000068105", "term"=>"Bipolar and Related Disorders"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "asFound"=>"Depression", "relevance"=>"HIGH"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "asFound"=>"Depression", "relevance"=>"HIGH"}, {"id"=>"M4996", "name"=>"Bipolar Disorder", "asFound"=>"Bipolar Depression", "relevance"=>"HIGH"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M21835", "name"=>"Mood Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M226", "name"=>"Bipolar and Related Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000005958", "term"=>"Palmidrol"}], "ancestors"=>[{"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000894", "term"=>"Anti-Inflammatory Agents, Non-Steroidal"}, {"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000063386", "term"=>"Cannabinoid Receptor Agonists"}, {"id"=>"D000063385", "term"=>"Cannabinoid Receptor Modulators"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000006728", "term"=>"Hormones"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}], "browseLeaves"=>[{"id"=>"M340341", "name"=>"Palmidrol", "asFound"=>"Bulimia", "relevance"=>"HIGH"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4218", "name"=>"Anti-Inflammatory Agents, Non-Steroidal", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-05-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in depression as assessed by the Hamilton Depression rating Scale (HAM-D)", "timeFrame"=>"Baseline, 6 weeks follow up", "description"=>"This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome"}], "secondaryOutcomes"=>[{"measure"=>"Percentage of participants that show a remission of depressive symptoms as assessed by the HAM-D scale.", "timeFrame"=>"from baseline to end of study (6 week follow up)", "description"=>"Remission of depressive symptoms are defined by a score of ≤7 on the HAM-D. This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome"}, {"measure"=>"Percentage of participants that show a response as assessed by the HAM-D scale", "timeFrame"=>"from baseline to end of study (6 week follow up)", "description"=>"Response rate is defined by ≥ 50 % reduction in depression score(HAM-D). This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome"}, {"measure"=>"Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score", "timeFrame"=>"From baseline to week 2 visit", "description"=>"This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome"}, {"measure"=>"Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)", "timeFrame"=>"Baseline, 6 weeks follow up", "description"=>"This is a 10 item questionnaire and each is scored from 0 -6 for a maximum score of 60, higher score indicating worse outcome"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["cytokine levels"], "conditions"=>["Bipolar Depression"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D\n* currently in use of at least one FDA approved mood stabilizer with or without antidepressant\n* medically and neurologically healthy on the basis of medical history, physical examination\n\nExclusion Criteria:\n\n* Cannabis misuse according to clinical judgement\n* unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects\n* active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)\n* acute high suicidal risk\n* in a manic episode\n* current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination\n* pregnant or nursing women\n* unstable medical conditions\n* clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available"}, "identificationModule"=>{"nctId"=>"NCT06229977", "briefTitle"=>"A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression", "organization"=>{"class"=>"OTHER", "fullName"=>"The University of Texas Health Science Center, Houston"}, "officialTitle"=>"A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression", "orgStudyIdInfo"=>{"id"=>"HSC-MS-21-0989"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"PEA plus Treatment as Usual (TAU)", "interventionNames"=>["Drug: Palmitoylethanolamide (PEA)", "Drug: Treatment as Usual (TAU)"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo plus Treatment as Usual (TAU)", "interventionNames"=>["Drug: Placebo", "Drug: Treatment as Usual (TAU)"]}], "interventions"=>[{"name"=>"Palmitoylethanolamide (PEA)", "type"=>"DRUG", "description"=>"Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.", "armGroupLabels"=>["PEA plus Treatment as Usual (TAU)"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks", "armGroupLabels"=>["Placebo plus Treatment as Usual (TAU)"]}, {"name"=>"Treatment as Usual (TAU)", "type"=>"DRUG", "description"=>"subjects will receive a mood stabilizer per usual care", "armGroupLabels"=>["PEA plus Treatment as Usual (TAU)", "Placebo plus Treatment as Usual (TAU)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc", "role"=>"CONTACT", "email"=>"Rodrigo.MachadoVieira@uth.tmc.edu", "phone"=>"(713) 486-2581"}, {"name"=>"Abdul Haseeb", "role"=>"CONTACT", "email"=>"Abdul.Haseeb@uth.tmc.edu", "phone"=>"(713) 486-2700"}], "facility"=>"The University of Texas Health Science Center at Houston", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "centralContacts"=>[{"name"=>"Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc", "role"=>"CONTACT", "email"=>"Rodrigo.MachadoVieira@uth.tmc.edu", "phone"=>"(713) 486-2581"}, {"name"=>"Abdul Haseeb", "role"=>"CONTACT", "email"=>"Abdul.Haseeb@uth.tmc.edu", "phone"=>"(713) 486-2700"}], "overallOfficials"=>[{"name"=>"Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"The University of Texas Health Science Center, Houston"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The University of Texas Health Science Center, Houston", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Baszucki Brain Research Fund", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Rodrigo Machado-Vieira, MD, PhD, MSc", "investigatorAffiliation"=>"The University of Texas Health Science Center, Houston"}}}}
