A Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep n a "Home Setting" in Adults With Chronic Insomnia. - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00414102

Purpose

This is a study to demonstrate the subjective treatment effects of 8 mg of ramelteon on sleep in adult subjects with chronic insomnia.

Condition	Intervention	Phase
Chronic Insomnia	Drug: Ramelteon Drug: Placebo	Phase IV

Drug Information available for: Ramelteon

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep Using a Post Sleep Questionnaire - Interactive Voice Response System (PSQ-IVRS) in an "At-Home Setting" in an Adult Population With Chronic Insomnia

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

To demonstrate the effects of ramelteon 8 mg on subjective assessment of sleep latency in an "at-home setting" in an adult population with chronic insomnia. [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure subjective sleep latency, subjective wake time after sleep onset, number of awakenings, quality of sleep and subjective total sleep time using the postsleep questionnaire-interactive voice recording system. [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
To assess rebound insomnia from via self-reported sleep latency during the single-blind run-out period. [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Enrollment:	552
Study Start Date:	October 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Inpatient	Drug: Ramelteon 8 mg ramelteon tablet, orally, once nightly for 21 nights. Drug: Placebo Placebo tablet, orally, once nightly for 21 nights.
2: Experimental Outpatient	Drug: Ramelteon 8 mg ramelteon tablet, orally, once nightly for 21 nights. Drug: Placebo Placebo tablet, orally, once nightly for 21 nights.

Detailed Description:

Subjects participating in this study are assigned to one of two groups: an inpatient group and an outpatient group. For the inpatient group, subjects undergo a polysomnography screening in a sleep laboratory for two nights. For the outpatient group, subjects visit a clinic briefly to receive their study medication. For both groups, a postsleep questionnaire-interactive voice recording system questionnaire is completed within 60 minutes of awakening each morning.

Subjects who meet all inclusion criteria and none of the exclusion criteria are then randomly assigned to receive either 8 mg of ramelteon or a placebo taken once nightly for 21 nights. Inpatient subjects undergo an additional 3 nights of polysomnography screening. For the duration of the treatment period, both inpatient and outpatient subjects are required to complete the PSQ-IVRS questionnaire each morning within 60 minutes of awakening.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject is between the ages of 18 and 64, inclusive; female subjects of childbearing potential must be non-pregnant and non-lactating.
The subject is fluent in English (speaking, writing, and reading).
Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:
- The predominant complaint is difficulty initiating or maintaining sleep, or non-restorative sleep, for at least 3 months.
- The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
- The sleep disturbance does not occur exclusively during the course of Narcolepsy, Breathing-Related Sleep Disorder, Circadian Rhythm Sleep Disorder, or a Parasomnia.
- The disturbance does not occur exclusively during the course of another mental disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder, and Delirium).
- The disturbance is not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition.

Exclusion Criteria:

The subject has sleep schedule changes required by employment (eg. shift worker) within three months prior to the administration of single-blind study medication.
The subject has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
The subject has ever had a history of seizures; sleep apnoea, restless leg syndrome (RLS), periodic leg movement syndrome (PLMS), chronic obstructive pulmonary disease (COPD) or fibromyalgia.
The subject has a history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414102

Show 52 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Sherry Weigand, MD

Takeda Global Research & Development Center

More Information

Responsible Party:	Takeda Global Research & Development Center, Inc. ( VP, Clinical Science )
Study ID Numbers:	01-05-TL-375-069
Study First Received:	December 19, 2006
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00414102
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Chronic Insomnia
Sleep Initiation and Maintenance Disorder
Drug Therapy

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009