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Effects of LDX on Functioning of College Students With ADHD

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ClinicalTrials.gov Identifier: NCT01342445
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
Sponsor:
Collaborator:
Lehigh University
Information provided by (Responsible Party):
Lisa Weyandt, University of Rhode Island

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention-deficit/Hyperactivity Disorder
Interventions Drug: lisdexamfetamine dimesylate
Drug: Placebo
Enrollment 50
Recruitment Details 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 Almost all participants completed all stages of the trial. One participant withdrew from the study after a possible adverse reaction.
Arm/Group Title Healthy Controls Attention-deficit/Hyperactivity Disorder (ADHD) Participants
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 26 24
Completed 26 22
Not Completed 0 2
Reason Not Completed
Experienced side effects             0             2
Arm/Group Title ADHD Participants Healthy Controls Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
26
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 26 participants 50 participants
20.17  (1.2) 20  (1.1) 20.17  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Female
9
  37.5%
12
  46.2%
21
  42.0%
Male
15
  62.5%
14
  53.8%
29
  58.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 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
[1]
Measure Description: Not all ethnicity categories are covered, and a participant may be counted in more than one ethnicity
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 26 participants 50 participants
24 26 50
Conners Adult Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  T score
Number Analyzed 24 participants 26 participants 50 participants
58.04  (7.51) 36.12  (4.98) 47.08 [2]   (NA)
[1]
Measure Description: 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.
[2]
The standard deviation was not pre-specified to be calculated.
BRIEF   [1] 
Mean (Standard Deviation)
Unit of measure:  T score
Number Analyzed 24 participants 26 participants 50 participants
65.41  (11.661) 44.31  (7.62) 54.86 [2]   (NA)
[1]
Measure Description: 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.
[2]
The standard deviation was not prespecified to be calculated for the total sample.
Year in College  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Freshman 3 5 8
Sophomore 7 6 13
Junior 4 7 11
Senior 10 8 18
Father's level of education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 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.Primary Outcome
Title Conners Adult ADHD Rating Scale - Short Version (CAARS)
Hide Description CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).
Time Frame after receiving Placebo or LDX for 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo LDX 30-mg LDX 50-mg LDX 70-mg
Hide Arm/Group Description:
All participants receiving Placebo for 1 week in a double-blind, crossover design
All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
Overall Number of Participants Analyzed 22 22 22 22
Mean (Standard Deviation)
Unit of Measure: T score
50.59  (10.975) 46.86  (9.939) 47.32  (10.092) 45.36  (10.790)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, LDX 30-mg, LDX 50-mg, LDX 70-mg
Comments This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.
Method ANOVA
Comments

F(4, 84) = 10.9

This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX).

Method of Estimation Estimation Parameter Partial eta squared
Estimated Value .34
Estimation Comments [Not Specified]
2.Primary Outcome
Title Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)
Hide Description BRIEF-A is a standardized self-report measure that captures adults’ views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.
Time Frame after receiving Placebo or LDX for 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo LDX 30-mg LDX 50-mg LDX 70-mg
Hide Arm/Group Description:
All participants receiving Placebo for 1 week in a double-blind, crossover design
All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
Overall Number of Participants Analyzed 22 22 22 22
Mean (Standard Deviation)
Unit of Measure: T score
65.91  (13.023) 59.23  (14.088) 57.64  (14.012) 54.91  (13.219)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, LDX 30-mg, LDX 50-mg, LDX 70-mg
Comments This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.
Method ANOVA
Comments

F(4, 84) = 8.14

This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX).

Method of Estimation Estimation Parameter partial eta squared
Estimated Value 0.28
Estimation Comments [Not Specified]
Time Frame Adverse event data was collected and updated on a daily basis during the 1 week receiving placebo or LDX.
Adverse Event Reporting Description If an adverse event occurred, the prescribing nurse would review with the participant and review risks. Adverse Events were only collected for the 24 participants who actually met inclusion criteria for ADHD and thus qualified for the medication trial
 
Arm/Group Title Placebo LDX 30-mg LDX 50-mg LDX 70-mg
Hide Arm/Group Description All participants receiving Placebo for 1 week in a double-blind, crossover design All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
All-Cause Mortality
Placebo LDX 30-mg LDX 50-mg LDX 70-mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo LDX 30-mg LDX 50-mg LDX 70-mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo LDX 30-mg LDX 50-mg LDX 70-mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      2/24 (8.33%)      0/24 (0.00%)      0/24 (0.00%)    
Cardiac disorders         
Possible Heart Palpitations * 1 [1]  0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Other
[1]
This was the adverse event for both participants. This occurred during week 1 of the medication trial in which both participants were taking an active dosage of 30mg.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Lisa Weyandt
Organization: University of Rhode Island
Phone: (401)874-2087
EMail: lisaweyandt@uri.edu
Layout table for additonal information
Responsible Party: Lisa Weyandt, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01342445     History of Changes
Other Study ID Numbers: Shire-80000311112
First Submitted: April 21, 2011
First Posted: April 27, 2011
Results First Submitted: August 6, 2013
Results First Posted: April 8, 2014
Last Update Posted: April 8, 2014