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

Condition(s) targeted: Chronic Insomnia

Intervention: Ramelteon (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Sherry Weigand, MD, Study Director, Affiliation: Takeda Global Research & Development Center

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

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.

To assess rebound insomnia from via self-reported sleep latency during the single-blind run-out period.

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.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Phoenix, Arizona, United States

Tucson, Arizona, United States

Hot Springs, Arkansas, United States

Los Angeles area, California, United States

San Diego, California, United States

Colorado Springs, Colorado, United States

Denver area, Colorado, United States

Ocala, Florida, United States

Naples, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

Ft. Myers, Florida, United States

Delray Beach, Florida, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Kansas City area, Kansas, United States

Lexington, Kentucky, United States

Baton Rouge, Louisiana, United States

Auburn, Maine, United States

Baltimore area, Maryland, United States

Washington D.C. area, Maryland, United States

Hattiesburg, Mississippi, United States

St. Louis area, Missouri, United States

Albuquerque, New Mexico, United States

Long Island, New York, United States

Rochester, New York, United States

Staten Island, New York, United States

New York, New York, United States

Morganton, North Carolina, United States

Winston/Salem, North Carolina, United States

Charlotte, North Carolina, United States

Cleveland, Ohio, United States

Gallipolis, Ohio, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland area, Oregon, United States

Pittsburgh, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Clarkes Summitt, Pennsylvania, United States

Anderson, South Carolina, United States

Charleston area, South Carolina, United States

Houston, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

Norfolk, Virginia, United States

Spokane, Washington, United States

Seattle area, Washington, United States

Milwaukee, Wisconsin, United States

Starting date: October 2006
Ending date: November 2007
Last updated: June 10, 2008