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Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD (Daytsleep)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arie Ashkenasi, MD, Cox Health Systems
ClinicalTrials.gov Identifier:
NCT00989950
First received: September 30, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
Results First Received: March 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
INSOMNIA
Intervention: Drug: Daytrana

  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
No text entered.

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
Group Sequence 1 Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 2 Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 3 Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 4 Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun

Participant Flow for 2 periods

 Period 1:   Open Label Dose Optimization
    Group Sequence 1     Group Sequence 2     Group Sequence 3     Group Sequence 4  
STARTED     6     9     4     7  
COMPLETED     6     9     4     7  
NOT COMPLETED     0     0     0     0  

Period 2:   Randomized Phase
    Group Sequence 1     Group Sequence 2     Group Sequence 3     Group Sequence 4  
STARTED     6     9     4     7  
COMPLETED     5     8     4     7  
NOT COMPLETED     1     1     0     0  
Protocol Violation                 1                 0                 0                 0  
Adverse Event                 0                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Group Sequence 1 Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 2 Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 3 Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 4 Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Total Total of all reporting groups

Baseline Measures
    Group Sequence 1     Group Sequence 2     Group Sequence 3     Group Sequence 4     Total  
Number of Participants  
[units: participants]
 		  6     9     4     7     26  
Age  
[units: participants]
 		         
<=18 years     6     9     4     7     26  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Gender  
[units: participants]
 		         
Female     2     3     1     1     7  
Male     4     6     3     6     19  
Attention Deficit Hyperactivity Disorder (ADHD) Subtype [1]
[units: participants]
 		         
Combined Subtype     4     6     3     7     20  
Other Subtype     2     3     1     0     6  
Conner's Global Impression-Parent Scale [2]
[units: scores on scale]
Mean ± Standard Deviation 		  13.7  ± 7.6     20.1  ± 6.8     25  ± 2.3     20.3  ± 6.7     19.78  ± 6.8  
Attention Deficit Hyperactivity Disorder Rating Scale-IV Total Score [3]
[units: Score on scale]
Mean ± Standard Deviation 		  27  ± 11     37  ± 9.2     41  ± 10.2     33.7  ± 10.6     34.7  ± 11  
Sleep Latency [4]
[units: minutes]
Mean ± Standard Deviation 		  22.5  ± 12.6     23.3  ± 21.8     54.5  ± 64.8     50.7  ± 12.4     37.8  ± 27.9  
Total Sleep Time [5]
[units: hours]
Mean ± Standard Deviation 		  9.9  ± .9     9.5  ± .9     10.6  ± 1.2     9.6  ± 1.8     9.9  ± 1.8  
Sleep Quality [6]
[units: Score]
Mean ± Standard Deviation 		  4.3  ± .8     4  ± 1     4  ± .8     3.1  ± .7     3.9  ± .8  
[1] There are 3 subtypes of ADHD as defined by the DSM-IV-TR. Inattentive, Hyperactive/Impulsive and combined subtype (hyperactive/impulsive and inattentive). "Other subtype" refers to individuals who are not of the combined subtype but instead are either hyperactive/impulsive or inattentive type.
[2] Rating scale filled out by the parents/caregivers. Scale consists of 28 questions divided into four subscales of oppositional problems, cognitive problems, hyperactivity and an ADHD index. Questions scored on a 4 point scale (0-3; 84 points possible), where a higher score indicates more severe symptom presentation.
[3] An 18-item scale corresponding to the 18 items in the DSM-IV-TR that is divided into two subsclaes: hyperactivity/impulsivity and inattentiveness. Items scored on a 4-point frequency scale ranging from 0=never/rarely to 3=very often; 54 points possible with higher score indicating more severe symptoms. Rating scale is filled out by the caregiver.
[4] Sleep latency was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality)
[5] Total sleep time was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality)
[6] Sleep quality was documented by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality). Assessed on a 5 point scale (0-lowest quality; 5-highest quality)



  Outcome Measures

1.  Primary:   Sleep Latency   [ Time Frame: 9 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Group Sequence 1 Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 2 Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 3 Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 4 Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun

Other Adverse Events
    Group Sequence 1     Group Sequence 2     Group Sequence 3     Group Sequence 4  
Total, other (not including serious) adverse events          
# participants affected / at risk     2/6     5/9     1/4     4/7  
Nervous system disorders          
Hallucinations *        
# participants affected / at risk     0/6 (0.00%)     1/9 (11.11%)     0/4 (0.00%)     0/7 (0.00%)  
# events     0     1     0     0  
Skin and subcutaneous tissue disorders          
skin reactions *        
# participants affected / at risk     2/6 (33.33%)     5/9 (55.56%)     1/4 (25.00%)     4/7 (57.14%)  
# events     4     7     2     6  
* Events were collected by non-systematic assessment



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
Small sample size, did not permit an examination of more specific differences among patch wear time conditions. Small sample size resulted in weaker randomization to patch wear time sequences that was not completely balanced in baseline covariates.  


Results Point of Contact:  
Name/Title: Arie Ashkenasi, MD
Organization: CoxHealth
phone: 011 972 50 3007477
e-mail: ashkenasi1@gmail.com


Publications of Results:


Responsible Party: Arie Ashkenasi, MD, Cox Health Systems
ClinicalTrials.gov Identifier: NCT00989950     History of Changes
Other Study ID Numbers: cox002, shire IND#54,732
Study First Received: September 30, 2009
Results First Received: March 12, 2012
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration