Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00889915
First received: April 27, 2009
Last updated: July 30, 2013
Last verified: July 2013
Results First Received: January 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Drug: Methylphenidate transdermal system
Drug: Lisdexamfetamine dimesylate
Drug: Osmotic-release oral system methylphenidate (OROS MPH)
Drug: Mixed amphetamine salts extended release

  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
Recruitment period was April to October 2009. Recruitment occurred at Child and Adolescent Psychiatry clinics in the USA.

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
Daytrana (Methylphenidate Transdermal System

Participants will receive methylphenidate transdermal system.

Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care.

Vyvanse (Lisdexamfetamine Dimesylate)

Participants will receive lisdexamfetamine dimesylate.

Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care.

Concerta (Osmotic-release Oral System Methylphenidate)

Participants will receive osmotic-release oral system methylphenidate (OROS MPH).

Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care.

Adderall (Mixed Amphetamine Salts Extended Release)

Participants will receive mixed amphetamine salts extended release.

Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care.


Participant Flow:   Overall Study
    Daytrana (Methylphenidate Transdermal System     Vyvanse (Lisdexamfetamine Dimesylate)     Concerta (Osmotic-release Oral System Methylphenidate)     Adderall (Mixed Amphetamine Salts Extended Release)  
STARTED     37     76     67     48  
COMPLETED     35     71     54     40  
NOT COMPLETED     2     5     13     8  



  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
Daytrana (Methylphenidate Transdermal System

Participants will receive methylphenidate transdermal system. Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:

Dose form as 10, 15, 20, 30 mg patches. Typical starting dose is 10 mg patch every day then titrate up by patch strength.

The FDA maximum dose per day is 30 mg and the off label maximum dose per day is 40 mg.

The patch should be applied to the hip area, avoiding the waistline and the patch application should be alternated between hips.

Vyvanse (Lisdexamfetamine Dimesylate)

Participants will receive lisdexamfetamine dimesylate.

Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:

Dose form is 20, 30, 40, 50, 60, 70 mg ivory body/ivory cap. The typical starting dose is 30 mg every day in the morning; dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals.

The FDA maximum dose per day is 70 mg. Afternoon doses should be avoided because of the potential for insomnia. Vyvanse may be taken with or without food. Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. The solution should be consumed immediately and should not be stored. The dose of a single capsule should not be divided.

Concerta (Osmotic-release Oral System Methylphenidate)

Participants will receive osmotic-release oral system methylphenidate (OROS MPH).

Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:

Dose form is 18, 27, 36, 54 mg capsules. The typical starting dose is 18 mg every morning. The FDA maximum dose per day is 54 mg in children or 72 mg in adolescents. The off label maximum dose is 108 mg. Longer acting stimulants offer greater convenience, confidentiality, and compliance with single daily dosing, but may have greater problematic effects on evening appetite and sleep. Its nonabsorbable tablet shell may appear in the stool.

Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care.

Adderall (Mixed Amphetamine Salts Extended Release)

Participants will receive mixed amphetamine salts extended release.

Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:

The dose form for is 5, 10, 15, 20, 25, 30 mg capsules. The typical starting dose for children greater than or equal to 6 years of age is 10 mg every day.

The FDA maximum dose per day is 30 mg if weight is greater than 50 kilograms. The off label maximum dose per day is 60 mg. The capsule may be opened and sprinkled on soft foods.

Total Total of all reporting groups

Baseline Measures
    Daytrana (Methylphenidate Transdermal System     Vyvanse (Lisdexamfetamine Dimesylate)     Concerta (Osmotic-release Oral System Methylphenidate)     Adderall (Mixed Amphetamine Salts Extended Release)     Total  
Number of Participants  
[units: participants]
  37     76     67     48     228  
Age  
[units: participants]
         
<=18 years     37     76     67     48     228  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  10.3  ± 3.2     10.6  ± 3.1     10.0  ± 3.2     10.4  ± 3.0     10.3  ± 3.1  
Gender  
[units: participants]
         
Female     10     21     25     16     72  
Male     27     55     42     32     156  
Region of Enrollment  
[units: participants]
         
United States     37     76     67     48     228  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale   [ Time Frame: Measured at each participant's last visit, which can occur at or before Week 6 ]

2.  Secondary:   Clinical Global Impressions-Improvement (CGI-I) Scale   [ Time Frame: Measured at each participant's last visit, which can occur at or before Week 6 ]

3.  Secondary:   Clinical Global Improvements-Acceptability (CGI-A) Scale   [ Time Frame: Measured at each participant's last visit, which can occur at or before Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: John S. March, MD, MPH
Organization: Duke Clinical Research Institute - Duke University School of Medicine
phone: 919-668-7818
e-mail: john.march@duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00889915     History of Changes
Other Study ID Numbers: Pro00014075, P30MH066386-02, DSIR CTM 4571; Pro00014075
Study First Received: April 27, 2009
Results First Received: January 22, 2013
Last Updated: July 30, 2013
Health Authority: United States: Federal Government