{"id":"lithium-or-valproate-with-aripiprazole","safety":{"commonSideEffects":[{"rate":null,"effect":"Akathisia"},{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Weight gain"},{"rate":null,"effect":"Sedation"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea (valproate)"},{"rate":null,"effect":"Polyuria/polydipsia (lithium)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Aripiprazole's partial agonism at dopamine and serotonin receptors helps normalize neurotransmitter activity in psychotic and mood disorders. Lithium inhibits inositol monophosphatase and glycogen synthase kinase-3 (GSK-3), affecting intracellular signaling cascades critical for mood regulation. Valproate increases GABA levels and inhibits histone deacetylase, promoting neuroprotection and mood stabilization. The combination leverages complementary mechanisms for enhanced efficacy in bipolar disorder.","oneSentence":"Aripiprazole acts as a dopamine D2/D3 receptor partial agonist and serotonin 5-HT1A partial agonist, while lithium and valproate modulate intracellular signaling and gene expression to enhance mood stabilization and reduce manic/depressive symptoms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:41:17.438Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Bipolar I disorder, acute manic or mixed episodes"},{"name":"Bipolar disorder maintenance treatment"}]},"trialDetails":[{"nctId":"NCT06433635","phase":"PHASE4","title":"Sequential Multiple Assignment Randomized Trial for Bipolar Depression","status":"ACTIVE_NOT_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2024-10-01","conditions":"Bipolar I Disorder, Depression","enrollment":2726},{"nctId":"NCT00261443","phase":"PHASE4","title":"A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2005-09","conditions":"Bipolar Disorder","enrollment":1270},{"nctId":"NCT00665366","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2008-06","conditions":"Bipolar Disorder Mania","enrollment":493},{"nctId":"NCT00257972","phase":"PHASE3","title":"Study of Aripiprazole in Patients With Bipolar I Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2004-10","conditions":"Bipolar Disorder","enrollment":400}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":88209,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Abilify","BMS-337039"],"phase":"marketed","status":"active","brandName":"Lithium or Valproate with Aripiprazole","genericName":"Lithium or Valproate with Aripiprazole","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Aripiprazole acts as a dopamine D2/D3 receptor partial agonist and serotonin 5-HT1A partial agonist, while lithium and valproate modulate intracellular signaling and gene expression to enhance mood stabilization and reduce manic/depressive episodes. Used for Bipolar I disorder, acute manic or mixed episodes, Bipolar disorder maintenance treatment.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}