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Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

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ClinicalTrials.gov Identifier: NCT00622427
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : May 24, 2013
Last Update Posted : May 24, 2013
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Rachel Fargason, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
ADHD With Sleep Onset Insomnia Drug: Ramelteon Drug: Placebo Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Study Start Date : February 2008
Primary Completion Date : February 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Ramelteon
8 mg tablets every night for 2 weeks
Other Name: Rozerem
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.
Drug: Placebo
placebo tablets for every night for 2 weeks



Primary Outcome Measures :
  1. Change in Baseline to 2 Weeks ADHD Rating Scale [ Time Frame: day 1 to day 14 of study drug ]
    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.


Secondary Outcome Measures :
  1. Change in Clinical Global Impression (CGI) [ Time Frame: day 1 to day 14 of study drug ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622427


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
University of Alabama at Birmingham
Takeda

Responsible Party: Rachel Fargason, MD, Associate Professosr, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00622427     History of Changes
Other Study ID Numbers: F071204001
First Posted: February 25, 2008    Key Record Dates
Results First Posted: May 24, 2013
Last Update Posted: May 24, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders