{"id":"aripiprazole-and-aripiprazole-once-monthly","safety":{"commonSideEffects":[{"rate":"10-25%","effect":"Akathisia"},{"rate":"10-20%","effect":"Headache"},{"rate":"5-15%","effect":"Anxiety"},{"rate":"5-15%","effect":"Insomnia"},{"rate":"5-10%","effect":"Nausea"},{"rate":"5-10%","effect":"Weight gain"},{"rate":"5-10%","effect":"Tremor"},{"rate":"5-15%","effect":"Injection site pain (once-monthly formulation)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Aripiprazole differs from typical antipsychotics by acting as a partial agonist rather than a full antagonist at dopamine D2 receptors. This mechanism allows it to modulate dopamine activity—increasing it when levels are low and decreasing it when levels are high—while also affecting serotonergic pathways. The once-monthly formulation is a long-acting injectable depot form that provides sustained therapeutic levels over an extended period.","oneSentence":"Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors, which stabilizes dopamine and serotonin neurotransmission in the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:02:24.058Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia"},{"name":"Bipolar I disorder (acute manic or mixed episodes)"},{"name":"Major depressive disorder (adjunctive treatment)"},{"name":"Irritability associated with autism spectrum disorder"}]},"trialDetails":[{"nctId":"NCT02431702","phase":"PHASE3","title":"A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2015-07-08","conditions":"Schizophrenia, Psychotic Disorders","enrollment":337},{"nctId":"NCT02237417","phase":"PHASE4","title":"Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism","status":"COMPLETED","sponsor":"University of Utah","startDate":"2014-09-01","conditions":"Schizophrenia","enrollment":47},{"nctId":"NCT04907279","phase":"","title":"Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)","status":"UNKNOWN","sponsor":"Otsuka Canada Pharmaceutical Inc.","startDate":"2021-11-01","conditions":"Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder","enrollment":200},{"nctId":"NCT03839251","phase":"PHASE4","title":"Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients","status":"COMPLETED","sponsor":"Chonbuk National University Hospital","startDate":"2018-06-01","conditions":"Schizophrenia","enrollment":82},{"nctId":"NCT02360319","phase":"PHASE4","title":"Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics","status":"COMPLETED","sponsor":"Vanguard Research Group","startDate":"2014-12-11","conditions":"Schizophrenia","enrollment":489},{"nctId":"NCT02146547","phase":"PHASE4","title":"European Long-acting Antipsychotics in Schizophrenia Trial","status":"COMPLETED","sponsor":"UMC Utrecht","startDate":"2015-02","conditions":"Schizophrenia","enrollment":536},{"nctId":"NCT02472652","phase":"PHASE4","title":"Aripiprazole, Abilify Maintena Collaborative Clinical Protocol","status":"TERMINATED","sponsor":"Gazda, Thomas D., M.D., PC","startDate":"2015-06","conditions":"Sexual Dysfunction","enrollment":2},{"nctId":"NCT01567527","phase":"PHASE3","title":"Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2012-08","conditions":"Bipolar I Disorder","enrollment":731},{"nctId":"NCT03005769","phase":"","title":"Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Europe Ltd","startDate":"2016-12","conditions":"Schizophrenia","enrollment":262},{"nctId":"NCT01795547","phase":"PHASE3","title":"Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia","status":"COMPLETED","sponsor":"H. Lundbeck A/S","startDate":"2013-02","conditions":"Schizophrenia","enrollment":295},{"nctId":"NCT02282085","phase":"PHASE4","title":"Treatment Study Comparing Aripiprazole Once Monthly With Standard of Care Medication in Outpatients With Schizophrenia","status":"UNKNOWN","sponsor":"Matt Byerly","startDate":"2014-12","conditions":"Schizophrenia","enrollment":200}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":137,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Aripiprazole: Abilify®","Aripiprazole (extended-release injectable suspension): Abilify Maintena®"],"phase":"phase_3","status":"active","brandName":"Aripiprazole and aripiprazole once-monthly","genericName":"Aripiprazole and aripiprazole once-monthly","companyName":"H. Lundbeck A/S","companyId":"h-lundbeck-a-s","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors, which stabilizes dopamine and serotonin neurotransmission in the brain. Used for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes), Major depressive disorder (adjunctive treatment).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}