Trial Outcomes & Findings for A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall (NCT NCT00468143)
NCT ID: NCT00468143
Last Updated: 2016-06-02
Results Overview
Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.
COMPLETED
PHASE4
62 participants
The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
2016-06-02
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
First Intervention (3 Weeks)
STARTED
|
31
|
31
|
|
First Intervention (3 Weeks)
COMPLETED
|
28
|
27
|
|
First Intervention (3 Weeks)
NOT COMPLETED
|
3
|
4
|
|
Second Intervention (3 Weeks)
STARTED
|
28
|
27
|
|
Second Intervention (3 Weeks)
COMPLETED
|
25
|
24
|
|
Second Intervention (3 Weeks)
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
First Intervention (3 Weeks)
Withdrawal by Subject
|
3
|
4
|
|
Second Intervention (3 Weeks)
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
Baseline characteristics by cohort
| Measure |
All Participants
n=62 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.
|
|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
46 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)Population: These is the total of participants who completed the study.
Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.
Outcome measures
| Measure |
Adderall IR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
Adderall XR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
|---|---|---|
|
Medication Event Monitoring System (MEMS®) Dosage Adherence
|
42.7 percentage of participants adherent
|
66.2 percentage of participants adherent
|
PRIMARY outcome
Timeframe: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.
Outcome measures
| Measure |
Adderall IR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
Adderall XR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
|---|---|---|
|
Medication Event Monitoring System (MEMS®) Regimen Adherence
|
2.5 percentage of participants adherent
|
34.4 percentage of participants adherent
|
PRIMARY outcome
Timeframe: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.
Outcome measures
| Measure |
Adderall IR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
Adderall XR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
|---|---|---|
|
Medication Event Monitoring System (MEMS®) Time Adherence
|
4.5 percentage of participants adherent
|
43.7 percentage of participants adherent
|
SECONDARY outcome
Timeframe: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)Study staff counted unused medication at each weekly visit to yield a percentage of prescribed pills that were consumed. For each group, the number given will be the total number of consumed pills divided by total number of pill prescribed.
Outcome measures
| Measure |
Adderall IR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
Adderall XR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
|---|---|---|
|
Pill Count
|
90.4 percentage of pills consumed
|
96.9 percentage of pills consumed
|
SECONDARY outcome
Timeframe: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)Self-reported adherence was ascertained via retrospective self-report of daily regimen adherence. Participants were considered adherent for Adderall IR (Methamphetamine salts) if they took the first does in the morning within 30 minutes of waking, and then each subsequent dose in 5-hour intervals (within 30 minutes). For Adderall XR (Methamphetamine salts), participants were considered adherent if they took the single daily dose in the morning within 30 minutes of waking. The number given below represents the total number of self-reported adherent participants divided by the total number of participants per group, times 100 (to obtain percentage).
Outcome measures
| Measure |
Adderall IR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
Adderall XR (Methamphetamine Salts)
n=49 Participants
All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale \[ADHD-RS\] scores) and tolerability.
|
|---|---|---|
|
Self Report
|
92.6 percentage of participants adherent
|
98.8 percentage of participants adherent
|
Adverse Events
Extended Release
Immediate Release
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended Release
n=62 participants at risk
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.
|
Immediate Release
n=62 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Headache
|
6.5%
4/62 • Number of events 6
|
17.7%
11/62 • Number of events 11
|
|
General disorders
Insomnia
|
22.6%
14/62 • Number of events 15
|
30.6%
19/62 • Number of events 20
|
|
General disorders
Loss of Appetite/Anorexia
|
37.1%
23/62 • Number of events 26
|
8.1%
5/62 • Number of events 7
|
|
Psychiatric disorders
Anxiety
|
11.3%
7/62 • Number of events 8
|
6.5%
4/62 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
1.6%
1/62 • Number of events 1
|
3.2%
2/62 • Number of events 2
|
|
Psychiatric disorders
Feeling Speedy or Wired or Jittery
|
9.7%
6/62 • Number of events 6
|
6.5%
4/62 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/62
|
3.2%
2/62 • Number of events 2
|
|
General disorders
Dry Mouth
|
22.6%
14/62 • Number of events 15
|
16.1%
10/62 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place