{"id":"methylphenidate-oral-product","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Insomnia"},{"rate":"10-20","effect":"Decreased appetite"},{"rate":"5-15","effect":"Headache"},{"rate":"5-10","effect":"Nervousness or anxiety"},{"rate":"5-10","effect":"Tachycardia"},{"rate":"5-10","effect":"Abdominal pain"}]},"_chembl":null,"_fixedAt":"2026-03-30T17:37:25.089790","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Methylphenidate is a sympathomimetic amine that inhibits the reuptake transporters (DAT and NET) for dopamine and norepinephrine, leading to increased concentrations of these neurotransmitters in the synaptic cleft. This enhanced dopaminergic and noradrenergic signaling improves attention, focus, and impulse control. The drug is a central nervous system stimulant commonly used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy.","oneSentence":"Methylphenidate blocks the reuptake of dopamine and norepinephrine in the central nervous system, increasing their availability at the synapse.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:21:03.172Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention-deficit/hyperactivity disorder (ADHD)"},{"name":"Narcolepsy"}]},"_fixedFields":["pubmed(2)"],"trialDetails":[{"nctId":"NCT03652740","phase":"PHASE1","title":"Effects of Commonly Used Medications on Mood and Choice","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2018-10-02","conditions":"Healthy","enrollment":25},{"nctId":"NCT06905587","phase":"PHASE3","title":"Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue","status":"RECRUITING","sponsor":"Odense University Hospital","startDate":"2025-09-02","conditions":"Brain Tumor, Pediatric, Cancer-related Fatigue, Methylphenidate","enrollment":50},{"nctId":"NCT04501653","phase":"EARLY_PHASE1","title":"Precision Functional Brain Mapping in Psilocybin","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2021-06-01","conditions":"Psilocybin","enrollment":11},{"nctId":"NCT05761756","phase":"NA","title":"Oxygen Toxicity: Mechanisms in Humans","status":"RECRUITING","sponsor":"Duke University","startDate":"2023-11-28","conditions":"Oxygen Toxicity, Hypercapnia, Seizures","enrollment":62},{"nctId":"NCT05978167","phase":"EARLY_PHASE1","title":"Targeting Drug Memories With Methylphenidate","status":"ACTIVE_NOT_RECRUITING","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2023-07-05","conditions":"Substance Use Disorder, Cocaine Use Disorder","enrollment":51},{"nctId":"NCT05880342","phase":"PHASE3","title":"The Role of the Brain in Mental and Physical Fatigue","status":"RECRUITING","sponsor":"Vrije Universiteit Brussel","startDate":"2023-05-03","conditions":"Fatigue","enrollment":62},{"nctId":"NCT03575403","phase":"PHASE1","title":"Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)","status":"COMPLETED","sponsor":"Craig Rush","startDate":"2018-09-01","conditions":"Alcohol Use Disorder","enrollment":19},{"nctId":"NCT05285683","phase":"PHASE2","title":"The Role of Brain Dopamine in Chronic Pain","status":"RECRUITING","sponsor":"University of Rochester","startDate":"2024-01-31","conditions":"Chronic Pain","enrollment":10},{"nctId":"NCT04603391","phase":"PHASE4","title":"Cannabidiol and CES1 Interactions in Healthy Subjects","status":"COMPLETED","sponsor":"University of Florida","startDate":"2021-02-25","conditions":"Drug Interaction","enrollment":14},{"nctId":"NCT02153944","phase":"PHASE4","title":"Cognitive vs. Emotional Psychopharmacological Manipulations of Fear vs. Anxiety","status":"COMPLETED","sponsor":"National Institute of Mental Health (NIMH)","startDate":"2014-06-16","conditions":"Anxiety Disorder","enrollment":142},{"nctId":"NCT04178993","phase":"PHASE1","title":"Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]","status":"COMPLETED","sponsor":"Craig Rush","startDate":"2019-09-01","conditions":"Methamphetamine Use Disorder","enrollment":8},{"nctId":"NCT04968522","phase":"PHASE4","title":"FASST - Fetal Alcohol Spectrum Stimulant Trial","status":"UNKNOWN","sponsor":"Monash Medical Centre","startDate":"2022-02-14","conditions":"Fetal Alcohol Spectrum Disorders","enrollment":20},{"nctId":"NCT05272397","phase":"NA","title":"Language & Cognitive Control","status":"COMPLETED","sponsor":"Donders Centre for Cognitive Neuroimaging","startDate":"2019-11-26","conditions":"Language, Methylphenidate of Undetermined Intent","enrollment":36},{"nctId":"NCT02361125","phase":"PHASE1","title":"Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2002-08-01","conditions":"Fatigue","enrollment":31},{"nctId":"NCT00901576","phase":"PHASE1","title":"A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers","status":"COMPLETED","sponsor":"Shire","startDate":"2009-05-18","conditions":"Healthy","enrollment":38},{"nctId":"NCT04138498","phase":"PHASE1, PHASE2","title":"CTx-1301 Comparative Bioavailability Study","status":"COMPLETED","sponsor":"Cingulate Therapeutics","startDate":"2019-12-06","conditions":"ADHD","enrollment":45},{"nctId":"NCT01616407","phase":"EARLY_PHASE1","title":"Effects of MDMA and Methylphenidate on Social Cognition","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2012-08","conditions":"Social Cognition","enrollment":30},{"nctId":"NCT02148783","phase":"PHASE2","title":"Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI","status":"TERMINATED","sponsor":"Uniformed Services University of the Health Sciences","startDate":"2014-09","conditions":"Traumatic Brain Injury","enrollment":11},{"nctId":"NCT03090269","phase":"PHASE2","title":"Methylphenidate for Cocaine Dependence","status":"WITHDRAWN","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2018-06-01","conditions":"Substance-Related Disorders","enrollment":""},{"nctId":"NCT01117181","phase":"PHASE2","title":"Apathy in Dementia Methylphenidate Trial (ADMET)","status":"COMPLETED","sponsor":"Johns Hopkins Bloomberg School of Public Health","startDate":"2010-06","conditions":"Apathy, Alzheimer's Disease","enrollment":60},{"nctId":"NCT01835548","phase":"PHASE3","title":"NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Neos Therapeutics, Inc","startDate":"2013-07","conditions":"Attention Deficit Hyperactivity Disorder (ADHD)","enrollment":87},{"nctId":"NCT00499746","phase":"PHASE1, PHASE2","title":"The Discriminative Effects of Tramadol in Humans","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"2007-11","conditions":"Opioid Abuse, Opioid Addiction, Stimulant Abuse","enrollment":20},{"nctId":"NCT00715520","phase":"NA","title":"Neurobiological Principles Applied to the Rehabilitation of Stroke Patients","status":"COMPLETED","sponsor":"Emory University","startDate":"2007-04","conditions":"Stroke","enrollment":33},{"nctId":"NCT02754258","phase":"PHASE3","title":"The Effects of Methylphenidate on Energy Intake and Energy Expenditure","status":"UNKNOWN","sponsor":"Children's Hospital of Eastern Ontario","startDate":"2017-01","conditions":"Obesity","enrollment":40},{"nctId":"NCT00223691","phase":"PHASE1","title":"Treatment of Orthostatic Hypotension in Autonomic Failure","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2002-03","conditions":"Autonomic Failure, Orthostatic Hypotension","enrollment":389},{"nctId":"NCT02704546","phase":"NA","title":"Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients","status":"UNKNOWN","sponsor":"Sheba Medical Center","startDate":"2016-04","conditions":"Methylphenidate","enrollment":20},{"nctId":"NCT01624649","phase":"","title":"A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2012-02","conditions":"Attention-deficit Hyperactivity Disorder","enrollment":289},{"nctId":"NCT01377662","phase":"PHASE2","title":"PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)","status":"COMPLETED","sponsor":"Tong Lee","startDate":"2011-08","conditions":"Methamphetamine Dependence, Cocaine Dependence","enrollment":30},{"nctId":"NCT01933880","phase":"PHASE4","title":"A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants","status":"COMPLETED","sponsor":"Xian-Janssen Pharmaceutical Ltd.","startDate":"2009-12","conditions":"Attention Deficit Hyperactivity Disorder (ADHD)","enrollment":194},{"nctId":"NCT00904670","phase":"PHASE3","title":"Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-04","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":45},{"nctId":"NCT02071615","phase":"NA","title":"Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","startDate":"2013-08","conditions":"Healthy","enrollment":48},{"nctId":"NCT00593138","phase":"PHASE1, PHASE2","title":"Study of Dopamine Transporter Receptor Occupancy With Long-acting Dex-methylphenidate","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2006-12","conditions":"Drug Binding to DAT Receptors","enrollment":23},{"nctId":"NCT01599975","phase":"PHASE3","title":"A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV","status":"UNKNOWN","sponsor":"University of California, Los Angeles","startDate":"2012-05","conditions":"HIV Dementia","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"recentPublications":[{"date":"2017 Jul","pmid":"28420586","title":"Impaired oral absorption of methylphenidate after Roux-en-Y gastric bypass.","journal":"Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery"},{"date":"2012 Sep","pmid":"22684402","title":"Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.","journal":"The AAPS journal"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Concerta, OROS-MPH","Central Nervous Systemt (CNS) stimulants"],"phase":"phase_3","status":"active","brandName":"Methylphenidate Oral Product","genericName":"Methylphenidate Oral Product","companyName":"Vrije Universiteit Brussel","companyId":"vrije-universiteit-brussel","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Methylphenidate blocks the reuptake of dopamine and norepinephrine in the central nervous system, increasing their availability at the synapse. Used for Attention-deficit/hyperactivity disorder (ADHD), Narcolepsy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}