Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Rachel Fargason, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00622427
First received: February 13, 2008
Last updated: April 2, 2013
Last verified: April 2013

February 13, 2008
April 2, 2013
February 2008
February 2010   (final data collection date for primary outcome measure)
Change in Baseline to 2 Weeks ADHD Rating Scale [ Time Frame: day 1 to day 14 of study drug ] [ Designated as safety issue: No ]
It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.
ADHD Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00622427 on ClinicalTrials.gov Archive Site
Change in Clinical Global Impression (CGI) [ Time Frame: day 1 to day 14 of study drug ] [ Designated as safety issue: No ]
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.
CGI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ADHD With Sleep Onset Insomnia
  • Drug: Ramelteon
    8 mg tablets every night for 2 weeks
    Other Name: Rozerem
  • Drug: Placebo
    placebo tablets for every night for 2 weeks
  • Experimental: Ramelteon then placebo
    8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.
    Intervention: Drug: Ramelteon
  • Experimental: Placebo then Ramelteon
    placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622427
F071204001
No
Rachel Fargason, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Takeda
Not Provided
University of Alabama at Birmingham
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP