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
Results First Received: June 5, 2012  
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
Condition: ADHD With Sleep Onset Insomnia
Interventions: Drug: Ramelteon
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ramelteon Then Placebo (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
Placebo Then Ramelteon (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep

Participant Flow:   Overall Study
    Ramelteon Then Placebo (8 mg)     Placebo Then Ramelteon (8 mg)  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ramelteon Then Placebo (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
Placebo Then Ramelteon (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
Total Total of all reporting groups

Baseline Measures
    Ramelteon Then Placebo (8 mg)     Placebo Then Ramelteon (8 mg)     Total  
Number of Participants  
[units: participants]
  16     16     32  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     16     32  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     9     6     15  
Male     7     10     17  
Region of Enrollment  
[units: participants]
     
United States     16     16     32  



  Outcome Measures
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1.  Primary:   Change in Baseline to 2 Weeks ADHD Rating Scale   [ Time Frame: day 1 to day 14 of study drug ]

2.  Secondary:   Change in Clinical Global Impression (CGI)   [ Time Frame: day 1 to day 14 of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: mfargason@uab.edu


No publications provided


Responsible Party: Rachel Fargason, MD, 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