{"id":"placebo-plus-lithium","safety":{"commonSideEffects":[{"rate":"25-50","effect":"Tremor"},{"rate":"20-40","effect":"Polyuria and polydipsia"},{"rate":"15-30","effect":"Cognitive dulling"},{"rate":"20-30","effect":"Weight gain"},{"rate":"10-20","effect":"Nausea"},{"rate":"5-10","effect":"Hypothyroidism"},{"rate":"5-10","effect":"Nephrogenic diabetes insipidus"}]},"_chembl":{"chemblId":"CHEMBL1201333","moleculeType":"Small molecule","molecularWeight":"6.94"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Placebo plus Lithium","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:38:32.412988+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:38:37.404399+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Placebo plus Lithium","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:38:37.814716+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201333/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:38:38.849247+00:00"}},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Lithium is a mood stabilizer that works through multiple mechanisms including inhibition of inositol monophosphatase and GSK-3, which affects intracellular signaling cascades involved in neuroplasticity and neuroprotection. It also modulates serotonin and norepinephrine neurotransmission. The 'placebo plus' designation indicates this is a combination study design comparing lithium with placebo control.","oneSentence":"Lithium modulates intracellular signaling pathways, particularly inhibiting glycogen synthase kinase-3 (GSK-3) and affecting monoamine neurotransmitter systems to stabilize mood.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:01:20.200Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:38:40.447868+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"name":"Bipolar disorder (acute mania and maintenance treatment)"},{"name":"Major depressive disorder (augmentation therapy)"},{"name":"Suicidal behavior prevention in mood disorders"}]},"trialDetails":[{"nctId":"NCT07459959","phase":"PHASE1, PHASE2","title":"LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response","status":"NOT_YET_RECRUITING","sponsor":"Johns Hopkins University","startDate":"2026-06-01","conditions":"Alzheimer s Disease","enrollment":40},{"nctId":"NCT07140913","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-10-08","conditions":"Mania, Bipolar Disorder","enrollment":424},{"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":"NCT04623398","phase":"PHASE3","title":"Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency)","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-02-21","conditions":"Autism Spectrum Disorder","enrollment":22},{"nctId":"NCT03185208","phase":"PHASE4","title":"Lithium As a Treatment to Prevent Impairment of Cognition in Elders","status":"COMPLETED","sponsor":"Ariel Gildengers, MD","startDate":"2018-02-02","conditions":"Mild Cognitive Impairment","enrollment":83},{"nctId":"NCT06339034","phase":"PHASE1, PHASE2","title":"Repurposing Lithium for Parkinson's Disease: a RCT","status":"ACTIVE_NOT_RECRUITING","sponsor":"State University of New York at Buffalo","startDate":"2024-07-03","conditions":"Parkinson Disease","enrollment":20},{"nctId":"NCT06008249","phase":"PHASE3","title":"Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)","status":"RECRUITING","sponsor":"Stichting TRICALS Foundation","startDate":"2021-08-09","conditions":"Amyotrophic Lateral Sclerosis","enrollment":171},{"nctId":"NCT05363293","phase":"PHASE1, PHASE2","title":"Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects","status":"COMPLETED","sponsor":"Alzamend Neuro, Inc.","startDate":"2022-05-04","conditions":"Alzheimer's Disease, Healthy Non-elderly and Elderly Adults","enrollment":65},{"nctId":"NCT05044611","phase":"PHASE4","title":"AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium","status":"ACTIVE_NOT_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-01-11","conditions":"Bipolar Disorder","enrollment":148},{"nctId":"NCT02862210","phase":"PHASE2","title":"Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia","status":"COMPLETED","sponsor":"Columbia University","startDate":"2017-01-27","conditions":"Frontotemporal Dementia (FTD)","enrollment":17},{"nctId":"NCT06662526","phase":"PHASE4","title":"Lithium for Prevention of Cognitive Declining in Mood Illnesses","status":"NOT_YET_RECRUITING","sponsor":"University of Chile","startDate":"2024-11-01","conditions":"Dementia, Bipolar Disorder (BD), Depression - Major Depressive Disorder","enrollment":250},{"nctId":"NCT03864094","phase":"PHASE4","title":"Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.","status":"COMPLETED","sponsor":"Helse Fonna","startDate":"2022-03-15","conditions":"Hemodynamic Instability, Anesthesia, General, Anesthesia, Intravenous","enrollment":128},{"nctId":"NCT05457036","phase":"NA","title":"Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile","status":"COMPLETED","sponsor":"Bone Health Technologies, Inc.","startDate":"2022-09-01","conditions":"Osteopenia, Low Bone Density","enrollment":94},{"nctId":"NCT02129348","phase":"PHASE2","title":"Treatment of Psychosis and Agitation in Alzheimer's Disease","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2014-06","conditions":"Alzheimer's Disease, Psychosis, Agitation","enrollment":77},{"nctId":"NCT06374043","phase":"PHASE4","title":"Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin.","status":"COMPLETED","sponsor":"University Medical Center Groningen","startDate":"2021-05-11","conditions":"Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2 With Proteinuria, Diabetes Mellitus","enrollment":20},{"nctId":"NCT06051240","phase":"PHASE2","title":"Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy","status":"RECRUITING","sponsor":"Region Stockholm","startDate":"2024-02-16","conditions":"Cognitive Impairment, Cognitive Decline, Radiotherapy Side Effect","enrollment":84},{"nctId":"NCT02870699","phase":"NA","title":"Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.","status":"COMPLETED","sponsor":"Institut de Cancérologie de Lorraine","startDate":"2011-10","conditions":"Breast Carcinoma","enrollment":50},{"nctId":"NCT01644747","phase":"PHASE2","title":"tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Besancon","startDate":"2012-07-19","conditions":"Resistant Depression, Moods Disorders, Unipolar Depression","enrollment":87},{"nctId":"NCT02600507","phase":"PHASE3","title":"Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2016-03-07","conditions":"Bipolar Depression","enrollment":529},{"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":"NCT05221593","phase":"PHASE3","title":"Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients","status":"COMPLETED","sponsor":"Al-Azhar University","startDate":"2020-08-01","conditions":"Neutropenia","enrollment":50},{"nctId":"NCT00312494","phase":"PHASE3","title":"3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects","status":"COMPLETED","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","startDate":"2006-04","conditions":"Bipolar Disorder","enrollment":680},{"nctId":"NCT00483548","phase":"PHASE3","title":"Adjunctive Ziprasidone in the Treatment of Bipolar I Depression","status":"COMPLETED","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","startDate":"2007-10","conditions":"Bipolar Disorder, Depression, Bipolar","enrollment":298},{"nctId":"NCT00961961","phase":"PHASE4","title":"Prevention of Relapse & Recurrence of Bipolar Depression","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2009-07-01","conditions":"Bipolar Disorder","enrollment":177},{"nctId":"NCT02967653","phase":"PHASE2","title":"Atorvastatin for the Treatment of Lithium-Induced Nephrogenic Diabetes Insipidus","status":"COMPLETED","sponsor":"Lady Davis Institute","startDate":"2017-07-13","conditions":"Lithium Use, Nephrogenic Diabetes Insipidus","enrollment":60},{"nctId":"NCT03204500","phase":"PHASE2","title":"Dual Treatment With Lithium and Valproate in ALS.","status":"COMPLETED","sponsor":"El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez","startDate":"2016-05","conditions":"Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis, Sporadic","enrollment":43},{"nctId":"NCT02630888","phase":"PHASE2","title":"Efficacy of Memantine add-on in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Patients","status":"UNKNOWN","sponsor":"University of Sao Paulo","startDate":"2014-08","conditions":"Bipolar Disorder","enrollment":44},{"nctId":"NCT03965247","phase":"NA","title":"Lithium Effects on Reward Processing and Reappraisal in Healthy Volunteers","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2011-10-31","conditions":"Healthy","enrollment":37},{"nctId":"NCT00643123","phase":"PHASE4","title":"Allopurinol Add-on Treatment for Refractory Mania","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","startDate":"2007-09","conditions":"Bipolar Disorder, Mixed Mania, Treatment-Resistant Mania","enrollment":40},{"nctId":"NCT03290963","phase":"PHASE2","title":"Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine","status":"WITHDRAWN","sponsor":"William V. Bobo, M.D.","startDate":"2017-11-30","conditions":"Treatment Resistant Depression","enrollment":""},{"nctId":"NCT01880593","phase":"PHASE2","title":"Ketamine Plus Lithium in Treatment-Resistant Depression","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2013-07","conditions":"Depression","enrollment":34},{"nctId":"NCT00183443","phase":"PHASE3","title":"Treatment of Mania Symptoms With Drug Therapy","status":"COMPLETED","sponsor":"Palo Alto Veterans Institute for Research","startDate":"2005-02","conditions":"Bipolar Disorder, Schizophrenia","enrollment":75},{"nctId":"NCT01797575","phase":"PHASE2","title":"N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2013-01","conditions":"Bipolar Disorder","enrollment":38},{"nctId":"NCT02039479","phase":"NA","title":"Randomized, Placebo-controlled Multicenter Trial of Lithium Plus Treatment as Usual (TAU) for Acute Suicidal Ideation and Behavior in Patients With Suicidal Major Depressive Episode","status":"UNKNOWN","sponsor":"Technische Universität Dresden","startDate":"2014-01","conditions":"Suicidal Ideation/Behavior, Depression","enrollment":254},{"nctId":"NCT00194129","phase":"PHASE3","title":"Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder","status":"COMPLETED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"1997-11","conditions":"Bipolar Disorder","enrollment":31},{"nctId":"NCT00000439","phase":"PHASE2","title":"Drug Treatment for Alcoholics With Bipolar Disorder","status":"COMPLETED","sponsor":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","startDate":"2000-10","conditions":"Alcoholism, Bipolar Disorder","enrollment":72},{"nctId":"NCT02593643","phase":"EARLY_PHASE1","title":"Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression.","status":"COMPLETED","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2016-01","conditions":"Major Depressive Disorder, Bipolar I Disorder, Bipolar II Disorder","enrollment":9},{"nctId":"NCT00224510","phase":"PHASE3","title":"A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2002-08","conditions":"Bipolar Disorder, Bipolar Depression","enrollment":120},{"nctId":"NCT01665950","phase":"PHASE2","title":"Simvastatin Augmentation of Lithium Treatment in Bipolar Depression","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2012-08","conditions":"Bipolar Disorder","enrollment":4},{"nctId":"NCT01784666","phase":"PHASE2","title":"Adjunctive Isradipine for the Treatment of Bipolar Depression","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2013-02","conditions":"Bipolar Disorder","enrollment":2},{"nctId":"NCT00562861","phase":"PHASE2, PHASE3","title":"Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram","status":"COMPLETED","sponsor":"Tufts Medical Center","startDate":"2007-11","conditions":"Bipolar Disorder, Bipolar Depression","enrollment":119},{"nctId":"NCT00063362","phase":"PHASE3","title":"Combination Therapy for the Treatment of Bipolar Disorders","status":"TERMINATED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2002-02","conditions":"Bipolar Disorder","enrollment":49},{"nctId":"NCT01669369","phase":"PHASE4","title":"Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2013-01","conditions":"Osteosarcoma","enrollment":400},{"nctId":"NCT00240110","phase":"PHASE1, PHASE2","title":"Valproate Efficacy in Cocaine-Bipolar Comorbidity","status":"COMPLETED","sponsor":"University of Miami","startDate":"2006-03","conditions":"Bipolar Disorder, Cocaine Dependence","enrollment":152},{"nctId":"NCT01358357","phase":"PHASE3","title":"Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2011-06","conditions":"Bipolar I Disorder","enrollment":965},{"nctId":"NCT00560079","phase":"PHASE4","title":"Efficacy of Allopurinol and Dypiridamole in Acute Mania","status":"COMPLETED","sponsor":"Hospital Espirita de Porto Alegre","startDate":"2003-11","conditions":"Mania","enrollment":180},{"nctId":"NCT01467700","phase":"PHASE3","title":"Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder","status":"TERMINATED","sponsor":"Takeda","startDate":"2011-12","conditions":"Acute Depressive Episode","enrollment":490},{"nctId":"NCT01134731","phase":"PHASE4","title":"Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2010-05","conditions":"Major Depressive Disorder, Suicidal Ideation","enrollment":54},{"nctId":"NCT01855594","phase":"PHASE2","title":"Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain","status":"COMPLETED","sponsor":"China Spinal Cord Injury Network","startDate":"2013-05","conditions":"Neuropathic Pain, Neuralgia, Spinal Cord Injuries","enrollment":60},{"nctId":"NCT00272025","phase":"PHASE1","title":"Treatment Resistant Bipolar Depression","status":"TERMINATED","sponsor":"Queen's University","startDate":"2006-10","conditions":"Bipolar Depression","enrollment":1},{"nctId":"NCT01977300","phase":"PHASE3","title":"Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2003-01","conditions":"Bipolar I Disorder","enrollment":159},{"nctId":"NCT02213614","phase":"NA","title":"Lithium Water in Gun Violence Prevention","status":"UNKNOWN","sponsor":"American Society Of Thermalism And Climatology Inc","startDate":"2014-08","conditions":"Assault by Handgun Discharge, Violence, Homicide","enrollment":400},{"nctId":"NCT02204969","phase":"PHASE1, PHASE2","title":"LIWA for Treatment of Alzheimer Patients","status":"UNKNOWN","sponsor":"American Society Of Thermalism And Climatology Inc","startDate":"2015-01","conditions":"Alzheimer Disease","enrollment":100},{"nctId":"NCT00221975","phase":"PHASE3","title":"Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling","status":"COMPLETED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2002-07","conditions":"Bipolar Disorder","enrollment":98},{"nctId":"NCT00868452","phase":"PHASE3","title":"Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2009-04","conditions":"Bipolar Depression","enrollment":348},{"nctId":"NCT01583023","phase":"PHASE4","title":"Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression","status":"UNKNOWN","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2014-04","conditions":"Bipolar Disorder","enrollment":45},{"nctId":"NCT01495156","phase":"PHASE4","title":"Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania","status":"WITHDRAWN","sponsor":"Northwell Health","startDate":"2011-09","conditions":"Bipolar I Disorder","enrollment":""},{"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":"NCT01284517","phase":"PHASE3","title":"Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2010-11","conditions":"Bipolar Depression","enrollment":356},{"nctId":"NCT01166425","phase":"PHASE2, PHASE3","title":"Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.","status":"COMPLETED","sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","startDate":"2010-06","conditions":"Bipolar Disorder","enrollment":81},{"nctId":"NCT00251316","phase":"PHASE2","title":"Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2005-11","conditions":"Thyroid Cancer, Differentiated Thyroid Carcinoma","enrollment":34},{"nctId":"NCT01096082","phase":"PHASE2, PHASE3","title":"Safety and Efficacy of Lithium Carbonate in Patients With Spinocerebellar Ataxia Type 3","status":"COMPLETED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2011-05","conditions":"Spinocerebellar Ataxia Type 3, Machado Joseph Disease","enrollment":62},{"nctId":"NCT00114686","phase":"PHASE3","title":"Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2006-01","conditions":"Bipolar I Disorder, Alcohol Dependence","enrollment":350},{"nctId":"NCT00206141","phase":"PHASE3","title":"Seroquel in Bipolar Depression Versus Lithium","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2005-08","conditions":"Bipolar Disorder, Bipolar Depression, Depression","enrollment":672},{"nctId":"NCT01257867","phase":"NA","title":"Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants","status":"TERMINATED","sponsor":"University of British Columbia","startDate":"2011-03","conditions":"Oxidative Stress","enrollment":5},{"nctId":"NCT00931723","phase":"PHASE4","title":"Adult Bipolar Mania","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2009-06","conditions":"Acute Mania","enrollment":356},{"nctId":"NCT01189812","phase":"PHASE2","title":"Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms","status":"COMPLETED","sponsor":"Columbia Northwest Pharmaceuticals","startDate":"2010-03","conditions":"Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified","enrollment":80},{"nctId":"NCT00035230","phase":"PHASE3","title":"A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2001-07","conditions":"Bipolar Disorder","enrollment":338},{"nctId":"NCT00309686","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-04","conditions":"Affective Psychosis, Bipolar, Bipolar Disorder, Mania","enrollment":300},{"nctId":"NCT00037674","phase":"PHASE3","title":"A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2001-01","conditions":"Bipolar Disorder","enrollment":434},{"nctId":"NCT00818389","phase":"PHASE2, PHASE3","title":"Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2009-01","conditions":"Amyotrophic Lateral Sclerosis","enrollment":84},{"nctId":"NCT01191918","phase":"PHASE4","title":"The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania","status":"COMPLETED","sponsor":"Shanghai Mental Health Center","startDate":"2005-05","conditions":"Bipolar Disorder, Mania","enrollment":40},{"nctId":"NCT01055392","phase":"PHASE2","title":"Disease-modifying Properties of Lithium in the Neurobiology of Alzheimer's Disease","status":"UNKNOWN","sponsor":"University of Sao Paulo","startDate":"2007-03","conditions":"Cognitive Impairment, Alzheimer Disease","enrollment":80},{"nctId":"NCT00107731","phase":"PHASE3","title":"Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2004-04","conditions":"Bipolar I Disorder","enrollment":710},{"nctId":"NCT00081380","phase":"PHASE3","title":"Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2004-03","conditions":"Bipolar Disorder","enrollment":710}],"_emaApprovals":[],"_faersSignals":[],"crossReferences":{"chemblId":"CHEMBL1201333"},"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Placebo plus Lithium","genericName":"Placebo plus Lithium","companyName":"Shanghai Mental Health Center","companyId":"shanghai-mental-health-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lithium carbonate was studied in combination with treatment as usual (TAU) for acute suicidal ideation and behavior in patients with suicidal major depressive episode. The study also included a placebo control group, indicating that the efficacy of lithium carbonate in this context was being compared to a placebo.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:38:40.447868+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}