Trial Outcomes & Findings for Effects of LDX on Functioning of College Students With ADHD (NCT NCT01342445)
NCT ID: NCT01342445
Last Updated: 2025-04-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
after receiving Placebo or LDX for 1 week
Results posted on
2025-04-24
Participant Flow
Participants were recruited from student disabilities and health service offices at two univer- sities in the Northeastern United States (one public and one private).
Almost all participants completed all stages of the trial. One participant withdrew from the study after a possible adverse reaction.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Experienced side effects
|
0
|
2
|
Baseline Characteristics
Effects of LDX on Functioning of College Students With ADHD
Baseline characteristics by cohort
| Measure |
ADHD Participants
n=24 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
n=26 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 only and received no drug.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20.17 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
20 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
20.17 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Conners Adult Rating Scale
|
58.04 T score
STANDARD_DEVIATION 7.51 • n=5 Participants
|
36.12 T score
STANDARD_DEVIATION 4.98 • n=7 Participants
|
47.08 T score
STANDARD_DEVIATION NA • n=5 Participants
|
|
BRIEF
|
65.41 T score
STANDARD_DEVIATION 11.661 • n=5 Participants
|
44.31 T score
STANDARD_DEVIATION 7.62 • n=7 Participants
|
54.86 T score
STANDARD_DEVIATION NA • n=5 Participants
|
|
Year in College
Freshman
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Year in College
Sophomore
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Year in College
Junior
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Year in College
Senior
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Father's level of education
Less than high school (HS)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Father's level of education
HS diploma or equivalent
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Father's level of education
Some college
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Father's level of education
Bachelor's degree
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Father's level of education
Graduate degree
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Father's level of education
Training program or certificate
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Mother's level of education
Less than high school (HS)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Mother's level of education
HS diploma or equivalent
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Mother's level of education
Some college
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Mother's level of education
Bachelor's degree
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Mother's level of education
Graduate degree
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Mother's level of education
Training program or certificate
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after receiving Placebo or LDX for 1 weekCAARS 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).
Outcome measures
| Measure |
Placebo
n=22 Participants
All participants receiving Placebo for 1 week in a double-blind, crossover design
|
LDX 30-mg
n=22 Participants
All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
|
LDX 50-mg
n=22 Participants
All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
|
LDX 70-mg
n=22 Participants
All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
|
|---|---|---|---|---|
|
Conners Adult ADHD Rating Scale - Short Version (CAARS)
|
50.59 T score
Standard Deviation 10.975
|
46.86 T score
Standard Deviation 9.939
|
47.32 T score
Standard Deviation 10.092
|
45.36 T score
Standard Deviation 10.790
|
PRIMARY outcome
Timeframe: after receiving Placebo or LDX for 1 weekBRIEF-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.
Outcome measures
| Measure |
Placebo
n=22 Participants
All participants receiving Placebo for 1 week in a double-blind, crossover design
|
LDX 30-mg
n=22 Participants
All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
|
LDX 50-mg
n=22 Participants
All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
|
LDX 70-mg
n=22 Participants
All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
|
|---|---|---|---|---|
|
Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)
|
65.91 T score
Standard Deviation 13.023
|
59.23 T score
Standard Deviation 14.088
|
57.64 T score
Standard Deviation 14.012
|
54.91 T score
Standard Deviation 13.219
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LDX 30-mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LDX 50-mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LDX 70-mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=24 participants at risk
All participants receiving Placebo for 1 week in a double-blind, crossover design
|
LDX 30-mg
n=24 participants at risk
All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
|
LDX 50-mg
n=24 participants at risk
All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
|
LDX 70-mg
n=24 participants at risk
All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
|
|---|---|---|---|---|
|
Cardiac disorders
Possible Heart Palpitations
|
0.00%
0/24 • Adverse event data was collected and updated on a daily basis during the 1 week receiving placebo or LDX.
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
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected and updated on a daily basis during the 1 week receiving placebo or LDX.
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
|
0.00%
0/24 • Adverse event data was collected and updated on a daily basis during the 1 week receiving placebo or LDX.
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
|
0.00%
0/24 • Adverse event data was collected and updated on a daily basis during the 1 week receiving placebo or LDX.
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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place