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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: ramelteon Clear all
Terminated Phase 3 Interventional Results available

Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder

NCT01467713
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Ramelteon SL, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 75 Years
Enrollment
642 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
138
States / cities
Birmingham, Alabama • Dothan, Alabama • Muscle Shoals, Alabama + 134 more
Source: ClinicalTrials.gov public record
Updated May 15, 2016 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 2 Interventional

Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease

NCT00325728
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
55 Years and older
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
72
States / cities
Alabaster, Alabama • Huntsville, Alabama • Phoenix, Arizona + 69 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2017 · Synced Sep 21, 2026, 5:50 AM EDT
Terminated Phase 4 Interventional Accepts healthy volunteers

A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

NCT00391755
View directory record Official record
Conditions
Migraine Headache
Interventions
ramelteon
Drug
Lead sponsor
Charlottesville Neuroscience
Other
Eligibility
18 Years to 65 Years
Enrollment
4 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2009
U.S. locations
1
States / cities
Charlottesville, Virginia
Source: ClinicalTrials.gov public record
Updated Feb 9, 2012 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 4 Interventional

The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU

NCT03931070
View directory record Official record
Conditions
Delirium
Interventions
Ramelteon, Placebo - Cap
Drug
Lead sponsor
Rhode Island Hospital
Other
Eligibility
18 Years and older
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Apr 9, 2024 · Synced Sep 21, 2026, 5:50 AM EDT
Not listed Phase 3 Interventional

Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.

NCT01128582
View directory record Official record
Conditions
Gastroesophageal Reflux Disease, Chronic Insomnia
Interventions
Rozerem (ramelteon), placebo
Drug
Lead sponsor
Southern Arizona VA Health Care System
Federal
Eligibility
Up to 82 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Tucson, Arizona
Source: ClinicalTrials.gov public record
Updated May 11, 2011 · Synced Sep 21, 2026, 5:50 AM EDT
Terminated Phase 4 Interventional Results available

Treating Chronic Insomnia in Breast Cancer Patients

NCT00337272
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Placebo, Ramelteon
Drug
Lead sponsor
Accelerated Community Oncology Research Network
Other
Eligibility
21 Years to 60 Years · Female only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
10
States / cities
Hot Springs, Arkansas • La Verne, California • Norwich, Connecticut + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 21, 2011 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 3 Interventional

Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia

NCT00656994
View directory record Official record
Conditions
Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 45 Years
Enrollment
122 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2004
U.S. locations
29
States / cities
Birmingham, Alabama • Jasper, Alabama • Mesa, Arizona + 26 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Not applicable Interventional

Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

NCT00811746
View directory record Official record
Conditions
Obstructive Sleep Apnea
Interventions
Rozerem (Ramelteon), Lunesta (Eszopiclone), Historical Controls
Drug · Other
Lead sponsor
Southern California Institute for Research and Education
Other
Eligibility
18 Years to 65 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Long Beach, California
Source: ClinicalTrials.gov public record
Updated May 29, 2013 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 3 Interventional

Ramelteon in Adults With Chronic Insomnia

NCT00671567
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 64 Years
Enrollment
848 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2003
U.S. locations
70
States / cities
Birmingham, Alabama • Mobile, Alabama • Mesa, Arizona + 67 more
Source: ClinicalTrials.gov public record
Updated Nov 19, 2012 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 2 Interventional Results available

Ramelteon in the Prevention of Post-operative Delirium

NCT02324153
View directory record Official record
Conditions
Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia, Cognitive Disorders
Interventions
Ramelteon, Microcrystalline Cellulose, Riboflavin 100 mg
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
65 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 29, 2020 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 4 Interventional

Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

NCT00414102
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 64 Years
Enrollment
552 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
52
States / cities
Phoenix, Arizona • Tucson, Arizona • Hot Springs, Arkansas + 49 more
Source: ClinicalTrials.gov public record
Updated Jun 27, 2016 · Synced Sep 21, 2026, 5:50 AM EDT
Terminated Phase 3 Interventional Results available

Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

NCT00642694
View directory record Official record
Conditions
Major Depressive Disorder, Insomnia
Interventions
Escitalopram, Ramelteon, Placebo
Drug · Other
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 70 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jul 25, 2019 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 3 Interventional

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.

NCT00671294
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon and Placebo (9 possible combinations total)
Drug
Lead sponsor
Takeda
Industry
Eligibility
65 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2003
U.S. locations
18
States / cities
Hot Springs, Arkansas • Irvine, California • Palm Springs, California + 15 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 21, 2026, 5:50 AM EDT
Withdrawn Phase 4 Interventional

Ramelteon and Citicoline for Delirium

NCT02840591
View directory record Official record
Conditions
Delirium
Interventions
Ramelteon, Citicoline
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Nov 8, 2017 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

NCT00507546
View directory record Official record
Conditions
Insomnia, Spinal Cord Injury, Tetraplegia, Sleep Disorders
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
US Department of Veterans Affairs
Federal
Eligibility
18 Years to 65 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2011
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated May 21, 2014 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 3 Interventional

Efficacy of Ramelteon in Subjects With Chronic Insomnia

NCT00671086
View directory record Official record
Conditions
Sleep Initiation and Maintenance Disorders
Interventions
Ramelteon
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
1,213 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2004
U.S. locations
122
States / cities
Birmingham, Alabama • Mobile, Alabama • Phoenix, Arizona + 119 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 21, 2026, 5:50 AM EDT
Terminated Not applicable Interventional Results available

Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism

NCT00745030
View directory record Official record
Conditions
REM Behavior Disorder, Parkinsonism
Interventions
Rozerem, Placebo
Drug
Lead sponsor
Northwestern University
Other
Eligibility
Not listed
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jan 8, 2024 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 4 Interventional

Safety of Ramelteon in Elderly Subjects

NCT00568789
View directory record Official record
Conditions
Insomnia
Interventions
Ramelteon, zolpidem and placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
65 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
6
States / cities
Costa Mesa, California • San Diego, California • Miami, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 21, 2026, 5:50 AM EDT
Terminated Phase 3 Interventional

Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance

NCT00585208
View directory record Official record
Conditions
Insomnia, Bipolar Disorder
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Lindner Center of HOPE
Other
Eligibility
18 Years to 65 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Mason, Ohio
Source: ClinicalTrials.gov public record
Updated May 9, 2013 · Synced Sep 21, 2026, 5:50 AM EDT
Not listed Phase 4 Interventional

Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia

NCT01180855
View directory record Official record
Conditions
Insomnia
Interventions
Placebo, Rozerem 8mg, Rozerem 8mg in combination with Multi Component Behavior Therapy
Drug · Other
Lead sponsor
University of Arizona
Other
Eligibility
18 Years to 64 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Tucson, Arizona
Source: ClinicalTrials.gov public record
Updated Aug 11, 2010 · Synced Sep 21, 2026, 5:50 AM EDT
Terminated Not applicable Interventional Results available

Clinical Management of Neuropathic Pain With Ramelteon

NCT00753623
View directory record Official record
Conditions
Neuropathic Pain
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 14, 2017 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 3 Interventional

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

NCT00671255
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
65 Years and older
Enrollment
829 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2004
U.S. locations
102
States / cities
Columbiana, Alabama • Mobile, Alabama • Muscle Shoals, Alabama + 99 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 21, 2026, 5:50 AM EDT
Not listed Phase 4 Interventional

Delirium Reduction With Ramelteon

NCT05069428
View directory record Official record
Conditions
Delirium
Interventions
Ramelteon 8mg
Drug
Lead sponsor
Centennial Medical Center
Other
Eligibility
18 Years and older
Enrollment
506 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Aug 21, 2024 · Synced Sep 21, 2026, 5:50 AM EDT
Completed Phase 4 Interventional Results available

Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

NCT00595504
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 12, 2012 · Synced Sep 21, 2026, 5:50 AM EDT