Trial · NCT00593736

Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

NCT00593736, Phase 2, Completed, Takeda; results first posted 2010-03-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome. Trials, record NCT00593736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00593736

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
NCT number: NCT00593736
Status: Completed
Phases: Phase 2
Enrollment: 132 participants, actual
Lead sponsor: Takeda
Conditions: Sleep Disorders, Circadian Rhythm
Interventions: Ramelteon, Ramelteon, Ramelteon, Placebo
First posted: 2008-01-15
Last updated: 2012-02-28
Results first posted: 2010-03-09

Source ClinicalTrials.gov

Registered outcomes60

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Nights 6-7	The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Secondary	Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Nights 13-14	The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Secondary	Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Nights 6-7	The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep.
Secondary	Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Nights 13-14	The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep.
Secondary	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)	Nights 6-7	The total sleep time divided by time-in-bed, multiplied by 100.
Secondary	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)	Nights 13-14	The total sleep time divided by time-in-bed, multiplied by 100.
Secondary	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)	Nights 6-7	The total sleep time divided by time-in-bed, multiplied by 100.
Secondary	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)	Nights 13-14	The total sleep time divided by time-in-bed, multiplied by 100.
Secondary	Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Nights 6-7	The number of wake minutes after the onset of persistent sleep prior to the end of recording.
Secondary	Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Nights 13-14	The number of wake minutes after the onset of persistent sleep prior to the end of recording.

1 to 10 of 60Source ClinicalTrials.gov

See all 60 registered outcomes

Outcomes60

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Nights 6-7	Analysis was conducted on the full analysis set (FAS), which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Nights 13-14	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Nights 6-7	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Nights 13-14	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)	Nights 6-7	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	percentage of time asleep	LEAST_SQUARES_MEAN
SECONDARY	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)	Nights 13-14	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	percentage of time asleep	LEAST_SQUARES_MEAN
SECONDARY	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)	Nights 6-7	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	percentage of time asleep	LEAST_SQUARES_MEAN
SECONDARY	Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)	Nights 13-14	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	percentage of time asleep	LEAST_SQUARES_MEAN
SECONDARY	Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Nights 6-7	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	minutes	LEAST_SQUARES_MEAN
SECONDARY	Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Nights 13-14	Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.	minutes	LEAST_SQUARES_MEAN

1 to 10 of 60Source ClinicalTrials.gov

See all 60 outcomes

Results by group240

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Ramelteon 1 mg QD	59.30	Standard Error 6.684	minutes
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Ramelteon 4 mg QD	39.40	Standard Error 6.352	minutes
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Ramelteon 8 mg QD	55.94	Standard Error 6.482	minutes
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Placebo QD	55.12	Standard Error 6.871	minutes
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Ramelteon 1 mg QD	48.36	Standard Error 6.849	minutes
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Ramelteon 4 mg QD	38.61	Standard Error 6.611	minutes
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Ramelteon 8 mg QD	45.29	Standard Error 6.732	minutes
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)	Placebo QD	46.64	Standard Error 6.983	minutes
Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Ramelteon 1 mg QD	376.41	Standard Error 8.158	minutes
Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)	Ramelteon 4 mg QD	383.51	Standard Error 7.876	minutes

1 to 10 of 240Source ClinicalTrials.gov

See all 240 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Screening Period and Placebo Run-in	STARTED	Ramelteon 1 mg QD	0
Screening Period and Placebo Run-in	STARTED	Ramelteon 4 mg QD	0
Screening Period and Placebo Run-in	STARTED	Ramelteon 8 mg QD	0
Screening Period and Placebo Run-in	STARTED	Placebo QD	549
Screening Period and Placebo Run-in	COMPLETED	Ramelteon 1 mg QD	0
Screening Period and Placebo Run-in	COMPLETED	Ramelteon 4 mg QD	0
Screening Period and Placebo Run-in	COMPLETED	Ramelteon 8 mg QD	0
Screening Period and Placebo Run-in	COMPLETED	Placebo QD	132
Screening Period and Placebo Run-in	NOT COMPLETED	Ramelteon 1 mg QD	0
Screening Period and Placebo Run-in	NOT COMPLETED	Ramelteon 4 mg QD	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Blood Creatine Phosphokinase Increased	Investigations	Ramelteon 1 mg QD	1	32
other	Blood Creatine Phosphokinase Increased	Investigations	Ramelteon 4 mg QD	0	33
other	Blood Creatine Phosphokinase Increased	Investigations	Ramelteon 8 mg QD	2	35
other	Blood Creatine Phosphokinase Increased	Investigations	Placebo QD	1	32
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Ramelteon 1 mg QD	0	32
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Ramelteon 4 mg QD	2	33
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Ramelteon 8 mg QD	0	35
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Placebo QD	0	32
other	Headache	Nervous system disorders	Ramelteon 1 mg QD	4	32
other	Headache	Nervous system disorders	Ramelteon 4 mg QD	1	33

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ramelteon 1 mg QD
Total, all-cause mortality	Ramelteon 4 mg QD
Total, all-cause mortality	Ramelteon 8 mg QD
Total, all-cause mortality	Placebo QD
Total, other adverse events	Ramelteon 1 mg QD	7	32
Total, other adverse events	Ramelteon 4 mg QD	5	33
Total, other adverse events	Ramelteon 8 mg QD	6	35
Total, other adverse events	Placebo QD	4	32
Total, serious adverse events	Ramelteon 1 mg QD	0	32
Total, serious adverse events	Ramelteon 4 mg QD	0	33

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Symbol Coding	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00593736

GET https://conductscience.org/api/trials/v1/NCT00593736/registered?page=2

API reference For AI assistants