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Completed

NCT Number: NCT00622427

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.

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Key information

Conditions

ADHD With Sleep Onset Insomnia

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramelteon

Drug

8 mg tablets every night for 2 weeks

Other names: Rozerem

Placebo

Drug

placebo tablets for every night for 2 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Takeda

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2008
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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