Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

This study is enrolling participants by invitation only.

First Received: February 13, 2008 Last Updated: February 12, 2009 History of Changes

Sponsor:	University of Alabama at Birmingham
Collaborator:	Takeda Global Research & Development Center, Inc.
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00622427

Purpose

Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.

Condition	Intervention	Phase
ADHD With Sleep Onset Insomnia	Drug: ramelteon or placebo Drug: ramelteon	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Resource links provided by NLM:

Drug Information available for: Ramelteon

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

ADHD Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CGI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: ramelteon 8 mg nightly for 2 weeks
2: Placebo Comparator Active vs placebo, crossover	Drug: ramelteon or placebo 8 mg or placebo tablets every night for 2 weeks, then a 2 week washout,then crossover to 8 mg tablets or placebo for 2 weeks.

Detailed Description:

Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of ADHD and insomnia-
19-65 years of age
In good general health
Negative pregnancy test

Exclusion Criteria:

Current primary psychiatric diagnosis other than ADHD
Positive urine drug screen for any sedative hypnotic or drugs of abuse
Unstable medical condition
HIV positive
Seizure disorder
Known hypersensitivity to Ramelteon

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622427

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205

Sponsors and Collaborators

University of Alabama at Birmingham

Takeda Global Research & Development Center, Inc.

More Information

No publications provided

Responsible Party:	University of Alabama at Birmingham ( Rachel Fargason, M.D. )
Study ID Numbers:	F071204001
Study First Received:	February 13, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00622427 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 08, 2010