49 completed, 13 terminated, 7 unknown, 5 withdrawn. 31 Phase 4, 19 Phase 3, 14 Phase 2, 7 Not applicable, 3 Phase 1.
Follow ramelteon: new trials by email Literature Review of ramelteon trials Research Report on ramelteon
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty Doxepin 6 mg, Ramelteon 8 mg, Placebo Tablets - Sleep Quality Post-TKA, Postoperative Knee Function | Phase 4 | Not yet recruiting | University of Washington | 129 | 2026-06-01 | 2026-05-20 |
| A Study of Ramelteon in Chinese Patients With Chronic Insomnia Ramelteon, Ramelteon placebo - Chronic Insomnia | Phase 3 | Not yet recruiting | Nanjing Chia-tai Tianqing Pharmaceutical | 280 | 2024-08-01 | 2024-07-22 |
| Melatonin Agonist for Shift-time Workers. Ramelteon - Circadian Rhythm Disorders | Phase 4 | Completed | Tri-Service General Hospital (TSGH) | 61 | 2024-03-04 | 2026-02-03 |
| Delirium Reduction With Ramelteon Ramelteon 8mg - Delirium | Phase 4 | Unknown | Centennial Medical Center | 506 | 2023-03-26 | 2024-08-22 |
| Insomnia Prevalence and Treatment Impact on Systemic Hypertension Ramelteon (RozeremR), sleep hygiene - Insomnia, Hypertension | Phase 4 | Terminated | University of Sao Paulo | 5 | 2022-05-01 | 2022-12-29 |
| Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19 Ramelteon 8mg - Covid19, Lung Injury | Phase 2 | Unknown | Associação Fundo de Incentivo à Pesquisa | 100 | 2020-09-01 | 2020-07-24 |
| Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults Ramelteon, Placebo - Delirium in Old Age | Phase 4 | Withdrawn | Brigham and Women's Hospital | 2019-12-01 | 2020-01-22 | |
| The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU Ramelteon, Placebo - Cap - Delirium | Phase 4 | Completed | Rhode Island Hospital | 112 | 2019-05-09 | 2024-04-10 |
| The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia Ramelteon 8mg, Placebo - Chronic Insomnia | Phase 4 | Completed | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | 17 | 2018-02-06 | 2024-11-20 |
| Ramelteon for Complex Insomnia in Veterans With PTSD Ramelteon, Usual Care - Insomnia | Phase 4 | Withdrawn | State University of New York at Buffalo | 2018-01-01 | 2021-04-09 | |
| The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy Ramelteon - Insomnia, Major Depressive Disorder | Phase 4 | Completed | Takeda | 26 | 2017-05-09 | 2019-07-22 |
| Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia Risperidone, Risperidone and Ramelteon, Haloperidol - Schizophrenia | Phase 4 | Completed | All India Institute of Medical Sciences, Bhubaneswar | 120 | 2017-05-01 | 2019-05-03 |
| Ramelteon in the Prevention of Post-operative Delirium Ramelteon, Microcrystalline Cellulose, Riboflavin 100 mg - Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders | Phase 2 | Completed | Johns Hopkins University | 80 | 2017-03-24 | 2020-06-30 |
| Ramelteon Prevention of Delirium - RCT ramelteon, Placebo - Delirium | Phase 4 | Unknown | Hartford Hospital | 240 | 2017-02-23 | 2018-08-01 |
| Ramelteon for Treatment of Insomnia in Cirrhosis Ramelteon Pill - Cirrhosis | Phase 4 | Completed | Virginia Commonwealth University | 10 | 2017-02-01 | 2021-03-29 |
| Ramelteon and Citicoline for Delirium Ramelteon, Citicoline - Delirium | Phase 4 | Withdrawn | University of Texas Southwestern Medical Center | 2016-07-01 | 2017-11-09 | |
| The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery Ramelteon, Placebo - Delirium, Sleep Deprivation | Not applicable | Unknown | University of California, San Diego | 120 | 2016-02-01 | 2022-02-08 |
| Effect of Ramelteon on Smoking Abstinence Ramelteon, Placebo - Tobacco Use Disorder | Phase 2 | Completed | University of Pennsylvania | 140 | 2015-09-01 | 2019-11-04 |
| A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolar 1 Disorder Ramelteon SL (Dose 1), Ramelteon SL (Dose 2), Placebo - Bipolar Disorder | Phase 3 | Withdrawn | Takeda | 2012-09-01 | 2013-01-23 | |
| Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder Ramelteon, Placebo - Bipolar Disorder | Phase 3 | Terminated | Takeda | 535 | 2012-08-01 | 2016-03-16 |
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Sleep Initiation and Maintenance Disorders (43) · Sleep Wake Disorders (9) · Delirium (7) · Bipolar Disorder (4) · Sleep Disorders, Intrinsic (4) · Chronobiology Disorders (3) · Parasomnias (3) · Parkinson Disease (3) · Sleep Apnea, Obstructive (3) · Depressive Disorder, Major (2) · Lewy Body Disease (2) · Migraine Disorders (2) · Parkinsonian Disorders (2) · Pulmonary Disease, Chronic Obstructive (2) · REM Sleep Behavior Disorder (2)
Takeda (31) · Massachusetts General Hospital (3) · Brigham and Women's Hospital (2) · Johns Hopkins University (2) · Lehigh Valley Hospital (2) · Northwestern University (2) · Southern California Institute for Research and Education (2) · University of Pennsylvania (2) · University of Texas Southwestern Medical Center (2) · Accelerated Community Oncology Research Network (1) · All India Institute of Medical Sciences, Bhubaneswar (1) · Associação Fundo de Incentivo à Pesquisa (1) · Centennial Medical Center (1) · Charlottesville Neuroscience (1) · Duke University (1)
United States (56) · Japan (3) · Czechia (2) · Germany (2) · Russia (2) · United Kingdom (2) · Australia (1) · Belgium (1) · Brazil (1) · Bulgaria (1) · Canada (1) · Finland (1) · France (1) · India (1) · Italy (1)
Edward R. Norris, MD (2) · Aleksandar Videnovic, M.D. (1) · Ali El Solh, MD (1) · Andrew Krystal, MD (1) · Andrius Baskys, M.D. (1) · Anthony Lequerica, PhD (1) · Brandon S Lu, MD, MS (1) · Catherine S. Sassoon, MD (1) · Chin-Bin Yeh, M.D., Ph.D. (1) · Dalva Poyares, PhD (1)
PMID 19327100, PMID 17015817, PMID 11559786, PMID 14735295, PMID 15683149, PMID 16185814, PMID 16709464, PMID 17294232, PMID 17335321, PMID 17519067, PMID 17803013, PMID 17996657, PMID 18584227, PMID 18627623, PMID 18691937, PMID 18691991, PMID 18840034, PMID 18853704, PMID 19090503, PMID 19228178, PMID 19284927, PMID 19294955, PMID 19317379, PMID 1950621, PMID 20483660, PMID 20861739, PMID 21206545, PMID 21296508, PMID 21359104, PMID 21966064, PMID 21975110, PMID 22122006, PMID 22194182, PMID 22963894, PMID 24090266, PMID 25887111, PMID 25956235, PMID 2748771, PMID 31567351, PMID 32532654, PMID 33189083, PMID 3616518, PMID 36702822, PMID 3757924, PMID 8791041, PMID 9396013, PMID 9406042
2004 (2), R01AG028769 (1), R01DK087913 (1), R21AG050850 (1), R21DA025794 (1), R21DA040902 (1)