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A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00468143
First received: April 30, 2007
Last updated: April 26, 2016
Last verified: April 2016
Results First Received: April 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Adderall ® Immediate Release
Drug: Adderall XR ®

  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
Men or women, aged 18 to 55 years, who met the DSM-IV criteria for ADHD, as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) version 1.2, were eligible to participate. Participants were recruited from local advertising or from the pool of participants at the MHADRP at NYU School of Medicine and VA NY Harbor Healthcare System.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Individuals who were currently receiving amphetamine or methylphenidate treatment underwent a 7-day washout period before the baseline visit; those receiving atomoxetine or other medications for ADHD were required to undergo a 28-day washout period before the baseline visit. While 62 subjects started the study, only 49 finished the full study.

Reporting Groups
  Description
Extended Release First This group received the extended release medication during the first three weeks of treatment and then received the immediate release medication during the last 3 weeks of treatment.
Immediate Release First This group received the immediate release medication during the first three weeks of treatment and then received the extended release medication during the last 3 weeks of treatment.

Participant Flow for 2 periods

Period 1:   First Intervention (3 Weeks)
    Extended Release First     Immediate Release First  
STARTED     31     31  
COMPLETED     28     27  
NOT COMPLETED     3     4  
Withdrawal by Subject                 3                 4  

Period 2:   Second Intervention (3 Weeks)
    Extended Release First     Immediate Release First  
STARTED     28     27  
COMPLETED     25     24  
NOT COMPLETED     3     3  
Withdrawal by Subject                 3                 3  



  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.
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Reporting Groups
  Description
All Participants This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  62  
Age  
[units: years]
Mean (Standard Deviation)
  35.7  (10.3)  
Gender  
[units: participants]
 
Female     28  
Male     34  
Race/Ethnicity, Customized  
[units: Participants]
 
Caucasian     46  
African American     7  
Hispanic     5  
Asian     4  



  Outcome Measures
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1.  Primary:   Medication Event Monitoring System (MEMS®) Dosage Adherence   [ Time Frame: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) ]

2.  Primary:   Medication Event Monitoring System (MEMS®) Regimen Adherence   [ Time Frame: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) ]

3.  Primary:   Medication Event Monitoring System (MEMS®) Time Adherence   [ Time Frame: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) ]

4.  Secondary:   Pill Count   [ Time Frame: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) ]

5.  Secondary:   Self Report   [ Time Frame: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks) ]


  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:  
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.


Results Point of Contact:  
Name/Title: Dr. Lenard Adler
Organization: NYU School of Medicine
phone: (212) 263-3580
e-mail: lenard.adler@nyumc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00468143     History of Changes
Other Study ID Numbers: IR v XR
Study First Received: April 30, 2007
Results First Received: April 17, 2013
Last Updated: April 26, 2016
Health Authority: United States: Institutional Review Board