search
Back to results

Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Primary Purpose

ADHD With Sleep Onset Insomnia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD With Sleep Onset Insomnia

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ramelteon then placebo

Placebo then Ramelteon

Arm Description

8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.

placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.

Outcomes

Primary Outcome Measures

Change in Baseline to 2 Weeks ADHD Rating Scale
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)
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.

Full Information

First Posted
February 13, 2008
Last Updated
April 2, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT00622427
Brief Title
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Official Title
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD With Sleep Onset Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramelteon then placebo
Arm Type
Experimental
Arm Description
8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.
Arm Title
Placebo then Ramelteon
Arm Type
Experimental
Arm Description
placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
8 mg tablets every night for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablets for every night for 2 weeks
Primary Outcome Measure Information:
Title
Change in Baseline to 2 Weeks ADHD Rating Scale
Description
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.
Time Frame
day 1 to day 14 of study drug
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression (CGI)
Description
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.
Time Frame
day 1 to day 14 of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

We'll reach out to this number within 24 hrs