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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition ADHD With Sleep Onset Insomnia
Interventions Drug: Ramelteon
Drug: Placebo
Enrollment 32

Recruitment Details Subjects were screened by medical and psychiatric history after responding to solicitation with advertisements in local newspapers and from existing clinic populations.
Pre-assignment Details  
Arm/Group Title Ramelteon Then Placebo (8 mg) Placebo Then Ramelteon (8 mg)
Hide Arm/Group Description QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
Period Title: Overall Study
Started 16 16
Completed 16 [1] 16 [2]
Not Completed 0 0
[1]
each subject received 2 weeks of Ramelteon, then 2 weeks of placebo after a two week wash out period
[2]
each subject received 2 weeks of placebo, then 2 weeks of Ramelteon after a two week wash out period
Arm/Group Title Ramelteon Then Placebo (8 mg) Placebo Then Ramelteon (8 mg) Total
Hide Arm/Group Description QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
16
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
9
  56.3%
6
  37.5%
15
  46.9%
Male
7
  43.8%
10
  62.5%
17
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Change in Baseline to 2 Weeks ADHD Rating Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ramelteon Placebo
Hide Arm/Group Description:
QD for 14 days prior to sleep first
QD for 14 days prior to sleep first
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of change
0  (0) 0  (0)
2.Secondary Outcome
Title Change in Clinical Global Impression (CGI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ramelteon Placebo
Hide Arm/Group Description:
QD for 14 days prior to sleep
QD for 14 days prior to sleep
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of change
0  (0) 0  (0)
Time Frame Length of study--average of 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ramelteon Then Placebo (8 mg) Placebo Then Ramelteon (8 mg)
Hide Arm/Group Description QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
All-Cause Mortality
Ramelteon Then Placebo (8 mg) Placebo Then Ramelteon (8 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ramelteon Then Placebo (8 mg) Placebo Then Ramelteon (8 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ramelteon Then Placebo (8 mg) Placebo Then Ramelteon (8 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/16 (18.75%)      4/16 (25.00%)    
Nervous system disorders     
Drowsiness *  2/16 (12.50%)  2 3/16 (18.75%)  3
Dizziness *  0/16 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Hives *  1/16 (6.25%)  1 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rachel Fargason
Organization: University of Alabama at Birmingham
Phone: 205-934-5151
Responsible Party: Rachel Fargason, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00622427     History of Changes
Other Study ID Numbers: F071204001
First Submitted: February 13, 2008
First Posted: February 25, 2008
Results First Submitted: June 5, 2012
Results First Posted: May 24, 2013
Last Update Posted: May 24, 2013