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
  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
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 32
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

Responsible Party: Rachel Fargason, MD, Associate Professosr, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00622427     History of Changes
Other Study ID Numbers: F071204001
Study First Received: February 13, 2008
Results First Received: June 5, 2012
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014