Trial Outcomes & Findings for Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD (NCT NCT00506285)
NCT ID: NCT00506285
Last Updated: 2015-01-16
Results Overview
This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
92 participants
Primary outcome timeframe
Double-blind endpoints during MTS and placebo arms
Results posted on
2015-01-16
Participant Flow
Subjects (n=92) were recruited from 4-16-2007 through 10-24-2008. They were seen at the Psychiatry Research Clinic at the University of Utah School of Medicine.
There were 3 screening visits. Subjects met DSM-IV \&/or Utah criteria for adult ADHD, experiencing at least moderate impairment. Most DSM-IV axis-I disorders were excluded. Of 92 subjects enrolled, 65 were randomized and produced double-blind data. The assessment procedure was more extensive than normal, leading to a high dropout rate.
Participant milestones
| Measure |
A) MTS Arm Was 1st and PBO Arm Was 2nd
MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
|
B) PBO Arm Was 1st and MTS Arm Was 2nd
Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
|
|---|---|---|
|
3 Week Screening Phase
STARTED
|
46
|
46
|
|
3 Week Screening Phase
COMPLETED
|
29
|
36
|
|
3 Week Screening Phase
NOT COMPLETED
|
17
|
10
|
|
Double Blind Cross-Over Phase
STARTED
|
29
|
36
|
|
Double Blind Cross-Over Phase
Received at Least 1 Dose MTS
|
29
|
31
|
|
Double Blind Cross-Over Phase
COMPLETED
|
20
|
31
|
|
Double Blind Cross-Over Phase
NOT COMPLETED
|
9
|
5
|
|
6-month Open Label Phase
STARTED
|
20
|
31
|
|
6-month Open Label Phase
COMPLETED
|
10
|
19
|
|
6-month Open Label Phase
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
A) MTS Arm Was 1st and PBO Arm Was 2nd
MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
|
B) PBO Arm Was 1st and MTS Arm Was 2nd
Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
|
|---|---|---|
|
3 Week Screening Phase
Withdrawal by Subject
|
17
|
10
|
|
Double Blind Cross-Over Phase
Withdrawal by Subject
|
4
|
3
|
|
Double Blind Cross-Over Phase
Lost to Follow-up
|
5
|
2
|
|
6-month Open Label Phase
Lost to Follow-up
|
1
|
7
|
|
6-month Open Label Phase
Withdrawal by Subject
|
9
|
5
|
Baseline Characteristics
Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD
Baseline characteristics by cohort
| Measure |
a) Methylphenidate Transdermal System Was Taken First
n=29 Participants
Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm
|
B Placebo Patch Was Used First
n=36 Participants
Placebo patch was used in the first treatment arm and MTS in the second treatment arm.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
40.4 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
35.2 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
36 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Wender-Reimherr Adult Attention Deficit Disorder Scale
|
21.5 units on a scale
STANDARD_DEVIATION 4.2 • n=99 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 4.1 • n=107 Participants
|
21.4 units on a scale
STANDARD_DEVIATION 4.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: Double-blind endpoints during MTS and placebo armsPopulation: All subjects given active treatment "last observation carried forward" using a mixed models design.
This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.
Outcome measures
| Measure |
Scores in MTS Arm
n=49 Participants
Average WRAADDS scores at end of active treatment (MTS) arm
|
Scores in Placebo Arm
n=49 Participants
Average WRAADDS scores at end of placebo arm
|
|---|---|---|
|
Wender Reimherr Adult Attention Deficit Disorder Scale
|
11.0 units on a scale
Standard Deviation 7.4
|
17.9 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Double-blind endpoints for MTS and placebo armsMeasures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.
Outcome measures
| Measure |
Scores in MTS Arm
n=49 Participants
Average WRAADDS scores at end of active treatment (MTS) arm
|
Scores in Placebo Arm
n=49 Participants
Average WRAADDS scores at end of placebo arm
|
|---|---|---|
|
Conners' Adult ADHD Rating Scales (CAARS)
|
30.8 units on a scale
Standard Deviation 19.1
|
49.5 units on a scale
Standard Deviation 18.8
|
Adverse Events
MTS Arm
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MTS Arm
n=61 participants at risk
Adverse events and Serious AEs during active treatment (MTS) arm
|
Placebo Arm
n=58 participants at risk
Adverse events and Serious AEs during placebo arm
|
|---|---|---|
|
General disorders
insomnia/sleep
|
31.1%
19/61 • Number of events 19 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
6.9%
4/58 • Number of events 4 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
|
General disorders
dry eyes, nose, mouth
|
13.1%
8/61 • Number of events 8 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
|
General disorders
headache
|
13.1%
8/61 • Number of events 8 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
6.9%
4/58 • Number of events 4 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
|
General disorders
anxiety
|
11.5%
7/61 • Number of events 7 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
|
Gastrointestinal disorders
decreased appetite
|
11.5%
7/61 • Number of events 7 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
3.4%
2/58 • Number of events 2 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
|
Psychiatric disorders
anger/irritability
|
11.5%
7/61 • Number of events 7 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
5.2%
3/58 • Number of events 3 • Adverse event data were collected during both double-blind treatment arms. Each arm was 4 weeks long. Subjects who did not complete the double-blind phase were included in the assessment.
A list of likely AEs were assessed at each visit. In addition, the investigator recorded any additional concerns by the subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place