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Effects of LDX on Functioning of College Students With ADHD

This study has been completed.
Sponsor:
Collaborator:
Lehigh University
Information provided by (Responsible Party):
Lisa Weyandt, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01342445
First received: April 21, 2011
Last updated: April 7, 2014
Last verified: March 2014
Results First Received: August 6, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention-deficit/Hyperactivity Disorder
Interventions: Drug: lisdexamfetamine dimesylate
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
Participants were recruited from student disabilities and health service offices at two univer- sities in the Northeastern United States (one public and one private).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Almost all participants completed all stages of the trial. One participant withdrew from the study after a possible adverse reaction.

Reporting Groups
  Description
Healthy Controls All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug.
Attention-deficit/Hyperactivity Disorder (ADHD) Participants All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg lisdexamfetamine dimesylate (LDX) in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. Each phase was conducted for 1 week, and therefore, the total trial took place over 5 weeks and was able to be completed during a single semester. Participants ingested one pill per day on awakening.

Participant Flow:   Overall Study
    Healthy Controls     Attention-deficit/Hyperactivity Disorder (ADHD) Participants  
STARTED     26     24  
COMPLETED     26     22  
NOT COMPLETED     0     2  
Experienced side effects                 0                 2  



  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
ADHD Participants All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition.
Healthy Controls All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline only and received no drug.
Total Total of all reporting groups

Baseline Measures
    ADHD Participants     Healthy Controls     Total  
Number of Participants  
[units: participants]
  24     26     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24     26     50  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  20.17  ± 1.2     20  ± 1.1     20.17  ± 1.2  
Gender  
[units: participants]
     
Female     9     12     21  
Male     15     14     29  
Race/Ethnicity, Customized [1]
[units: participants]
     
White non-Hispanic     22     21     43  
African American     1     0     1  
Hispanic     0     3     3  
Asian/Pacific Islander     1     1     2  
Indian     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     24     26     50  
Conners Adult Rating Scale [2]
[units: T score]
Mean ± Standard Deviation
  58.04  ± 7.51     36.12  ± 4.98     47.08  ± NA [3]
BRIEF [4]
[units: T score]
Mean ± Standard Deviation
  65.41  ± 11.661     44.31  ± 7.62     54.86  ± NA [5]
Year in College  
[units: participants]
     
Freshman     3     5     8  
Sophomore     7     6     13  
Junior     4     7     11  
Senior     10     8     18  
Father's level of education  
[units: participants]
     
Less than high school (HS)     0     0     0  
HS diploma or equivalent     6     6     12  
Some college     2     3     5  
Bachelor's degree     11     7     18  
Graduate degree     5     9     14  
Training program or certificate     0     1     1  
Mother's level of education  
[units: participants]
     
Less than high school (HS)     1     0     1  
HS diploma or equivalent     3     3     6  
Some college     5     4     9  
Bachelor's degree     9     8     17  
Graduate degree     6     9     15  
Training program or certificate     0     2     2  
[1] Not all ethnicity categories are covered, and a participant may be counted in more than one ethnicity
[2] The Conners was converted to a T score with a mean of 50 and standard deviation of 10. Higher scores represent more severe ADHD symptoms.
[3] The standard deviation was not pre-specified to be calculated.
[4] The BRIEF was converted to a T score with a mean of 50 and a standard deviation of 10. Higher scores represent poorer levels of functioning.
[5] The standard deviation was not prespecified to be calculated for the total sample.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Conners Adult ADHD Rating Scale - Short Version (CAARS)   [ Time Frame: after receiving Placebo or LDX for 1 week ]

2.  Primary:   Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)   [ Time Frame: after receiving Placebo or LDX for 1 week ]


  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
No notable limitations or caveats are noted.


  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. Lisa Weyandt
Organization: University of Rhode Island
phone: (401)874-2087
e-mail: lisaweyandt@uri.edu


Publications of Results:

Responsible Party: Lisa Weyandt, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01342445     History of Changes
Other Study ID Numbers: Shire-80000311112
Study First Received: April 21, 2011
Results First Received: August 6, 2013
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration