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Showing 1–24 of 58 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Ramelteon Clear all
Not listed Phase 4 Interventional

Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

NCT01207050
View directory record Official record
Conditions
Insomnia, Brain Injury
Interventions
Ramelteon, Placebo
Drug · Dietary Supplement
Lead sponsor
Kessler Foundation
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
1
States / cities
West Orange, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 8, 2014 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 3 Interventional

Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

NCT00247390
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
451 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
19
States / cities
Birmingham, Alabama • Hot Springs, Arkansas • Los Angeles, California + 16 more
Source: ClinicalTrials.gov public record
Updated Jun 2, 2010 · Synced Sep 2, 2026, 5:22 AM EDT
Terminated Phase 3 Interventional

Efficacy of Ramelteon in Adults With Chronic Insomnia

NCT00672724
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 64 Years
Enrollment
1,081 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005
U.S. locations
43
States / cities
Mesa, Arizona • Phoenix, Arizona • Scottsdale, Arizona + 40 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 2, 2026, 5:22 AM EDT
Terminated Phase 3 Interventional Results available

Ramelteon for Insomnia Comorbid With Asthma

NCT00869167
View directory record Official record
Conditions
Insomnia, Asthma
Interventions
Ramelteon
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years to 60 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 30, 2013 · Synced Sep 2, 2026, 5:22 AM EDT
Terminated Phase 3 Interventional Results available

Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

NCT01677182
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 75 Years
Enrollment
535 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
41
States / cities
Birmingham, Alabama • Anaheim, California • Glendale, California + 38 more
Source: ClinicalTrials.gov public record
Updated Mar 15, 2016 · Synced Sep 2, 2026, 5:22 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 2, 2026, 5:22 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

NCT00492011
View directory record Official record
Conditions
Circadian Dysregulation
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 50 Years
Enrollment
110 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007
U.S. locations
4
States / cities
Miami, Florida • Pembroke Pines, Florida • Honolulu, Hawaii + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 2, 2026, 5:22 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 2, 2026, 5:22 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 2, 2026, 5:22 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 2, 2026, 5:22 AM EDT
Terminated Not applicable Interventional Results available

Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety

NCT00746239
View directory record Official record
Conditions
Panic Disorder, Insomnia
Interventions
Placebo and Escitalopram, Ramelteon and Escitalopram
Drug
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
18 Years to 50 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 29, 2018 · Synced Sep 2, 2026, 5:22 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 2, 2026, 5:22 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 2, 2026, 5:22 AM EDT
Completed Phase 4 Interventional Results available

Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

NCT00492232
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon and zolpidem, Placebo and zolpidem
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
41
States / cities
Hot Springs, Arkansas • Anaheim, California • Fountain Valley, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2010 · Synced Sep 2, 2026, 5:22 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 2, 2026, 5:22 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 2, 2026, 5:22 AM EDT
Completed Phase 4 Interventional Results available

Ramelteon for Treatment of Insomnia in Cirrhosis

NCT03091738
View directory record Official record
Conditions
Cirrhosis
Interventions
Ramelteon Pill
Drug
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
21 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Mar 28, 2021 · Synced Sep 2, 2026, 5:22 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 2, 2026, 5:22 AM EDT
Terminated Phase 3 Interventional Results available

Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

NCT01467700
View directory record Official record
Conditions
Acute Depressive Episode
Interventions
Ramelteon SL, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 75 Years
Enrollment
490 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
141
States / cities
Birmingham, Alabama • Dothan, Alabama • Muscle Shoals, Alabama + 137 more
Source: ClinicalTrials.gov public record
Updated May 15, 2016 · Synced Sep 2, 2026, 5:22 AM EDT
Not listed Phase 4 Interventional

Ramelteon Prevention of Delirium - RCT

NCT02564939
View directory record Official record
Conditions
Delirium
Interventions
ramelteon, Placebo
Drug
Lead sponsor
Hartford Hospital
Other
Eligibility
65 Years and older
Enrollment
240 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Hartford, Connecticut
Source: ClinicalTrials.gov public record
Updated Jul 31, 2018 · Synced Sep 2, 2026, 5:22 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 2, 2026, 5:22 AM EDT
Withdrawn Phase 4 Interventional

Ramelteon for Complex Insomnia in Veterans With PTSD

NCT03265951
View directory record Official record
Conditions
Insomnia
Interventions
Ramelteon, Usual Care
Drug · Other
Lead sponsor
State University of New York at Buffalo
Other
Eligibility
18 Years to 70 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Apr 8, 2021 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 4 Interventional

Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder

NCT01401413
View directory record Official record
Conditions
REM Sleep Behavior Disorder
Interventions
ramelteon, placebo
Drug
Lead sponsor
Sleep Medicine Centers of WNY
Other
Eligibility
18 Years to 80 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
West Seneca, New York
Source: ClinicalTrials.gov public record
Updated Jul 24, 2011 · Synced Sep 2, 2026, 5:22 AM EDT
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 2, 2026, 5:22 AM EDT