Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
This study has been completed.
Sponsor:
University of Alabama at Birmingham
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: April 2, 2013
Last verified: April 2013
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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
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 Global Research & Development Center, Inc.
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 Attention Deficit Disorder with Hyperactivity Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders |
Nervous System Diseases Mental Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood |
ClinicalTrials.gov processed this record on May 23, 2013