Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

This study has been completed.

Sponsor:

Collaborator:

Takeda Global Research & Development Center, Inc.

Information provided by (Responsible Party):

Rachel Fargason, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00622427

First received: February 13, 2008

Last updated: March 15, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 13, 2008
Last Updated Date	March 15, 2012
Start Date ^ICMJE	February 2008
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 22, 2008)	ADHD Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00622427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 22, 2008)	CGI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Official Title ^ICMJE	Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Brief Summary	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.
Detailed Description	Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	ADHD With Sleep Onset Insomnia
Intervention ^ICMJE	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. Other Name: Rozerem Drug: ramelteon 8 mg nightly for 2 weeks Other Name: Rozerem
Study Arm (s)	Active Comparator: 1 Intervention: Drug: ramelteon Placebo Comparator: 2 Active vs placebo, crossover Intervention: Drug: ramelteon or placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	December 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	19 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00622427
Other Study ID Numbers ^ICMJE	F071204001
Has Data Monitoring Committee	No
Responsible Party	Rachel Fargason, MD, University of Alabama at Birmingham
Study Sponsor ^ICMJE	University of Alabama at Birmingham
Collaborators ^ICMJE	Takeda Global Research & Development Center, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	University of Alabama at Birmingham
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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