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Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR

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ClinicalTrials.gov Identifier: NCT00393042
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mark Stein, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Dexmethylphenidate
Drug: Mixed Amphetamine Salts, ER
Drug: placebo
Enrollment 77
Recruitment Details Eligible participants were recruited from the investigators' practices, clinic referrals, and radio advertisements. Participants were enrolled between January 2007 and January 2009.
Pre-assignment Details 7 participants didn't want to participate after screening, 1 didn't meet criteria, 1 ADHD was not the primary condition, 1 showed an abnormal lab/physical/EKG, 1 was unable to swallow pills, 1 had an exclusionary medical condition, 1 was removed due to protocol violations.
Arm/Group Title Focalin XR Then Adderall XR Adderall XR Then Focalin XR
Hide Arm/Group Description Focalin XR first for 4 weeks (3 dose levels and placebo) then Adderall XR for 4 weeks (3 dose levels and placebo). Adderall XR first for 4 weeks (3 dose levels and placebo) then Focalin XR for 4 weeks (3 dose levels and placebo).
Period Title: First Intervention
Started 31 33
Completed the Placebo Dosage 27 29
Completed 10mg Dosage 29 29
Completed 20 mg Dosage 26 28
Completed 25/30mg Dosage 27 27
Completed 26 27
Not Completed 5 6
Reason Not Completed
Withdrawal by Subject             1             2
Lost to Follow-up             3             3
Protocol Violation             1             0
Adverse Event             0             1
Period Title: Second Intervetion
Started 26 27
Completed Placebo Dosage 25 21
Completed 10 mg Dosage 26 24
Completed the 20mg Dosage 24 21
Completed 25/30 mg Dosage 24 20
Completed 24 19
Not Completed 2 8
Reason Not Completed
Adverse Event             0             3
Withdrawal by Subject             0             2
Lack of Efficacy             1             0
Lost to Follow-up             0             2
Protocol Violation             1             1
Arm/Group Title Overall Study
Hide Arm/Group Description Participants either Adderall XR or Focalin XR for four weeks (3 dose levels and placebo) followed by four weeks (3 dose levels and placebo) of the opposite medication they received the first four weeks. Baseline Measures are based off all participants that were randomized regardless of the order they received the medication. Since we were interested in evaluating efficacy and adverse events at all dose conditions, participants were included in analysis if they received at least 2 weeks of study drug to insure that all participants had been exposed to at least one week of active drug
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
77 individuals were screened , 13 patients were excluded, 64 patients were randomized. Of the 64 randomized, 21 discontinued at various points during the trial.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
<=18 years
64
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants
11.7  (2.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
17
  26.6%
Male
47
  73.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants
64
1.Primary Outcome
Title Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.
Hide Description Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.
Time Frame 8-10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with complete and valid actigraphy (n = 37) and sleep diaries were used to calculate sleep onset latency and sleep duration.
Arm/Group Title Placebo 10mg of Either Focalin XR or Adderall XR 20mg of Either Focalin XR or Adderall XR 25/30mg of Either Focalin XR or Adderall XR Adderall XR All Dose Levels Focalin XR All Dose Levels
Hide Arm/Group Description:
Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
Overall Number of Participants Analyzed 37 37 37 37 37 37
Mean (Standard Deviation)
Unit of Measure: HHMM.SS
Sleep start time 2249  (0012.19) 2304  (0010.40) 2319  (0012.21) 2325  (0011.17) 2309  (0011.05) 2309  (0011.19)
Sleep End time 0742  (0015.36) 0728  (0009.54) 0735  (0010.46) 0732  (0011.09) 0735  (0010.40) 0734  (0010.04)
2.Primary Outcome
Title Sleep Duration
Hide Description Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.
Time Frame 8-10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with sufficient sleep actigraphy data for analysis (n=37)
Arm/Group Title Placebo 10mg of Either Focalin XR or Adderall XR 20 mg of Either Focalin XR or Adderall XR 25/30mg of Either Focalin XR or Adderall XR Adderall XR All Dose Levels Focalin XR All Dose Levels
Hide Arm/Group Description:
Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
Each participant received 25/30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
Overall Number of Participants Analyzed 37 37 37 37 37 37
Mean (Standard Deviation)
Unit of Measure: minutes
459.6  (73.6) 446.7  (63.58) 432.17  (64.6) 425.5  (61.5) 438.82  (67.2) 443.2  (66.9)
3.Secondary Outcome
Title ADHD Parent Rating Scale-IV
Hide Description Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.
Time Frame completed weekly over 8-10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adderall XR - Placebo Adderall XR - 10 mg Adderall XR - 20 mg Adderall XR - 25/30mg Focalin XR - Placebo Focalin XR - 10 mg Focalin XR - 20 mg Focalin XR - 25/30mg
Hide Arm/Group Description:
This is the placebo dosage week for the Adderall XR medication.
This is the 10 mg dosage week for the Adderall XR medication.
This is the 20 mg dosage week for the Adderall XR medication.
This is the 25/30 mg dosage week for the Adderall XR medication.
This is the placebo dosage week for the Focalin XR medication.
This is the 10 mg dosage week for the Focalin XR medication.
This is the 20 mg dosage week for the Focalin XR medication.
This is the 25/30 mg dosage week for the Focalin XR medication.
Overall Number of Participants Analyzed 48 53 47 47 54 55 52 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
Inattention Symptom Subscale Scores 16.61  (7.8) 6.40  (8.55) 12.2  (8.08) 12.74  (8.38) 17.31  (8.23) 17.51  (7.03) 13.33  (7.08) 12.11  (8.72)
Hyperactivity/Impulsivity Symptom subscale scores 11.41  (8.55) 10.78  (7.60) 7.92  (6.78) 7.67  (6.62) 13.24  (8.91) 10.84  (7.37) 8.49  (7.37) 8.49  (6.70)
Total Symptoms scores 28.02  (15.15) 27.15  (14.49) 20.12  (13.87) 20.40  (13.68) 30.58  (15.33) 28.35  (12.74) 21.82  (12.72) 20.41  (13.61)
4.Secondary Outcome
Title Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms
Hide Description Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele. The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication. The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level. The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms. The subscales are summed to calculate the total score which can range from 0 to 54. The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.
Time Frame 8-10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed differs from the participant flow because some participants refused to provide a DNA sample for analysis or some participants did not have the allele type that was being observed. Of those that provided a DNA sample, 6 had the 9/9 allele on the DAT 1 gene, 15 had the 9/10 allele and 30 had the 10/10 allele.
Arm/Group Title 9/9 Allele: Placebo of Adderall XR 9/9 Allele: 10 mg of Adderall XR 9/9 Allele: 20 mg Adderall XR 9/9 Allele: 25/30mg of Adderall XR 9/9 Allele: Placebo of Focalin XR 9/9 Allele: 10 mg of Focalin XR 9/9 Allele: 20 mg of Focalin XR 9/9 Allele: 25/30 mg of Focalin XR 9/10 Allele: Placebo of Adderall XR 9/10 Allele: 10 mg of Adderall XR 9/10 Allele: 20 mg of Adderall XR 9/10 Allele: 25/30 mg of Adderall XR 9/10 Allele: Placebo of Focalin XR 9/10 Allele: 10 mg of Focalin XR 9/10 Allele: 20 mg of Focalin XR 9/10 Allele: 25/30 mg of Focalin XR 10/10 Allele: Placebo of Adderall XR 10/10 Allele: 10 mg of Adderall XR 10/10 Allele: 20 mg of Adderall XR 10/10 Allele: 25/30 mg of Adderall XR 10/10 Allele: Placebo of Focalin XR 10/10 Allele: 10 mg of Focalin XR 10/10 Allele: 20 mg of Focalin XR 10/10 Allele: 25/30mg of Focaling XR
Hide Arm/Group Description:
This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/9 allele
This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
This is the placebo dosage of Focalin XR medication phase for the participants with the 9/9 allele
This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele
This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele
This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele
This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele
This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
Overall Number of Participants Analyzed 5 6 5 5 3 5 4 4 14 15 14 14 13 15 12 10 30 30 29 26 27 27 27 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
ADHD-RS Inattention subscale score 18.60  (9.61) 18.83  (10.59) 19.00  (8.51) 15.40  (9.18) 19.33  (7.51) 22.20  (4.76) 16.75  (8.81) 12.50  (9.81) 18.64  (6.55) 16.27  (7.33) 15.86  (6.71) 13.43  (7.95) 18.08  (8.51) 16.93  (5.59) 13.36  (8.27) 13.70  (9.86) 15.07  (8.14) 16.13  (9.35) 9.36  (7.88) 11.96  (8.65) 16.44  (8.44) 16.56  (7.92) 12.56  (6.64) 11.15  (8.61)
ADHD-RS Hyperactivity/Impulsivity subscale score 12.80  (8.90) 18.33  (10.03) 14.80  (8.07) 10.40  (9.96) 17.33  (2.52) 17.40  (4.77) 14.00  (9.13) 9.00  (7.07) 9.36  (8.95) 10.67  (7.74) 8.36  (7.04) 6.43  (6.95) 8.92  (9.38) 8.27  (7.23) 6.73  (7.04) 7.00  (7.02) 11.87  (8.76) 9.63  (6.83) 7.07  (6.18) 7.50  (5.70) 13.74  (9.19) 10.63  (7.14) 8.41  (6.34) 8.65  (6.46)
ADHD-RS total score 31.40  (18.06) 37.17  (20.55) 33.80  (16.33) 25.80  (19.03) 36.67  (6.43) 39.60  (8.44) 30.75  (17.63) 24.00  (17.19) 28.00  (13.59) 26.80  (13.14) 24.21  (13.01) 19.86  (12.84) 27.08  (15.71) 25.20  (11.89) 20.09  (13.71) 20.70  (15.84) 26.93  (16.05) 25.77  (14.33) 16.43  (13.01) 19.46  (13.20) 30.19  (16.49) 27.19  (12.93) 20.96  (11.98) 19.81  (13.26)
CGI-S score 4.40  (0.55) 4.33  (1.51) 4.80  (1.30) 4.00  (1.58) 4.67  (0.58) 4.60  (0.55) 4.50  (1.29) 4.00  (1.63) 4.36  (1.08) 4.07  (1.03) 3.71  (1.14) 3.50  (1.40) 4.31  (0.95) 4.27  (0.70) 3.58  (1.38) 3.90  (1.66) 4.17  (1.39) 4.07  (1.48) 3.21  (1.32) 3.54  (1.24) 4.15  (1.29) 4.19  (0.83) 3.52  (1.12) 3.31  (1.26)
5.Secondary Outcome
Title Clinical Global Impression - Severity
Hide Description The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.
Time Frame 8-10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed differs from the participant flow in the Focalin XR groups because the CGI-S was not completed for every participant. The same is true for the Adderall XR - 25/30mg group.
Arm/Group Title Adderall XR - Placebo Adderall XR - 10 mg Adderall XR - 20 mg Adderall XR - 25/30 mg Focalin XR - Placebo Focalin - 10 mg Focalin XR - 20 mg Focalin XR - 25/30 mg
Hide Arm/Group Description:
This is the placebo dosage week for the Adderall XR medication.
This is the 10 mg dosage week for the Adderall XR medication.
This is the 20 mg dosage week for the Adderall XR medication.
This is the 25/30 mg dosage week for the Adderall XR medication.
This is the placebo dosage week for the Focalin XR medication.
This is the 10 mg dosage week for the Focalin XR medication.
This is the 20 mg dosage week for the Focalin XR medication.
This is the 25/30 mg dosage week for the Focalin XR medication.
Overall Number of Participants Analyzed 54 55 52 48 45 51 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.26  (1.18) 4.09  (1.29) 3.48  (1.34) 3.56  (1.27) 4.24  (1.13) 4.24  (0.76) 3.63  (1.20) 3.55  (1.35)
6.Secondary Outcome
Title Weiss Functional Impairment Rating Scale (WFIRS)
Hide Description The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment. The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42). The subscales are scored by summing the responses in the subsection. The Total score is the sum of all the responses and it ranges between 0-150. The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score.
Time Frame 8-10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed differs from the participant flow in all of the groups besides the Adderall XR - 10mg group because the WFIRS was not completed for every participant.
Arm/Group Title Adderall XR - Placebo Adderall XR - 10 mg Adderall XR - 20 mg Adderall XR - 25/30mg Focalin XR - Placebo Focalin XR - 10 mg Focalin XR - 20 mg Focalin XR - 25/30mg
Hide Arm/Group Description:
This is the placebo dosage week for the Adderall XR medication.
This is the 10 mg dosage week for the Adderall XR medication.
This is the 20 mg dosage week for the Adderall XR medication.
This is the 25/30 mg dosage week for the Adderall XR medication.
This is the Placebo dosage week for the Focalin XR medication.
This is the 10 mg dosage week for the Focalin XR medication.
This is the 20 mg dosage week for the Focalin XR medication.
This is the 25/30 mg dosage week for the Focalin XR medication.
Overall Number of Participants Analyzed 53 55 51 47 44 48 46 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Family subscale score 6.72  (6.13) 7.02  (6.41) 6.35  (6.10) 6.70  (7.14) 7.39  (7.14) 7.35  (6.09) 6.50  (6.42) 6.50  (6.46)
Learning subscale score 6.74  (5.63) 8.75  (6.70) 6.86  (6.19) 6.21  (5.62) 9.30  (6.34) 9.25  (5.94) 7.54  (5.24) 7.39  (5.78)
Life skills subscale score 7.43  (4.32) 7.91  (4.78) 7.44  (4.99) 7.34  (4.45) 8.30  (4.76) 7.65  (4.44) 8.30  (5.48) 7.60  (5.66)
Self-concept subscale score 1.11  (1.46) 1.59  (2.05) 1.42  (1.80) 1.06  (1.61) 1.25  (1.97) 1.19  (1.47) 1.33  (1.61) 1.31  (1.97)
Social activities subscale score 3.51  (3.53) 3.91  (3.81) 2.98  (3.10) 3.06  (4.05) 3.73  (4.14) 3.85  (3.57) 3.54  (3.40) 3.17  (3.98)
Risky activities subscale score 2.19  (2.56) 1.94  (2.30) 2.24  (3.41) 1.68  (2.23) 1.91  (1.64) 1.96  (2.12) 1.78  (1.78) 1.67  (1.73)
Total score 27.70  (17.03) 31.06  (18.93) 27.32  (19.53) 26.23  (19.74) 20.91  (17.50) 31.13  (17.11) 29.20  (17.71) 27.45  (18.54)
Time Frame 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks.
Adverse Event Reporting Description At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
 
Arm/Group Title Placebo of Focalin XR 10mg of Focalin XR 20 mg of Focalin XR 25/30mg of Focalin XR Placebo of Adderall XR 10mg of Adderall XR 20 mg of Adderall XR 25/30mg of Adderall XR
Hide Arm/Group Description Each participant recieved placebo of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule. Each participant recieved 10 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule. Each participant recieved 20 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule. Each participant recieved 25/30 mg (depending on weight) of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule. Each participant recieved placebo of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule. Each participant recieved 10 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule. Each participant recieved 20 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule. Each participant recieved 25/30 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
All-Cause Mortality
Placebo of Focalin XR 10mg of Focalin XR 20 mg of Focalin XR 25/30mg of Focalin XR Placebo of Adderall XR 10mg of Adderall XR 20 mg of Adderall XR 25/30mg of Adderall XR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo of Focalin XR 10mg of Focalin XR 20 mg of Focalin XR 25/30mg of Focalin XR Placebo of Adderall XR 10mg of Adderall XR 20 mg of Adderall XR 25/30mg of Adderall XR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/53 (0.00%)      1/47 (2.13%)      0/47 (0.00%)      0/54 (0.00%)      0/55 (0.00%)      0/52 (0.00%)      0/51 (0.00%)    
Nervous system disorders                 
Seizure * 1 [1]  0/48 (0.00%)  0 0/53 (0.00%)  0 1/47 (2.13%)  1 0/47 (0.00%)  0 0/54 (0.00%)  0 0/55 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SERS
[1]
Subject shaking in bed,unresponsive,eyes rolled upward. Taken to ER. ECG showed possible prolonged QTc. Subject evaluated overnight. No other events. Diagnosed on 12/29 with "benign rolandic seizures." No further cardiac evaluation recommended.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo of Focalin XR 10mg of Focalin XR 20 mg of Focalin XR 25/30mg of Focalin XR Placebo of Adderall XR 10mg of Adderall XR 20 mg of Adderall XR 25/30mg of Adderall XR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/48 (33.33%)      23/53 (43.40%)      32/47 (68.09%)      22/47 (46.81%)      23/54 (42.59%)      35/55 (63.64%)      29/52 (55.77%)      31/51 (60.78%)    
Gastrointestinal disorders                 
Stomach Ache  1  1/48 (2.08%)  1 2/53 (3.77%)  2 0/47 (0.00%)  0 1/47 (2.13%)  1 1/54 (1.85%)  1 1/55 (1.82%)  1 1/52 (1.92%)  1 3/51 (5.88%)  3
General disorders                 
Talk less  1  2/48 (4.17%)  2 0/53 (0.00%)  0 2/47 (4.26%)  2 2/47 (4.26%)  2 0/54 (0.00%)  0 1/55 (1.82%)  1 0/52 (0.00%)  0 3/51 (5.88%)  3
Irritable  1  3/48 (6.25%)  3 1/53 (1.89%)  1 7/47 (14.89%)  7 5/47 (10.64%)  5 3/54 (5.56%)  3 4/55 (7.27%)  4 5/52 (9.62%)  5 1/51 (1.96%)  1
Headache  1  0/48 (0.00%)  0 2/53 (3.77%)  2 0/47 (0.00%)  0 0/47 (0.00%)  0 2/54 (3.70%)  2 1/55 (1.82%)  1 1/52 (1.92%)  1 2/51 (3.92%)  2
Nail biting  1  3/48 (6.25%)  3 7/53 (13.21%)  7 9/47 (19.15%)  9 6/47 (12.77%)  6 4/54 (7.41%)  4 9/55 (16.36%)  9 7/52 (13.46%)  7 5/51 (9.80%)  5
Nightmare  1  0/48 (0.00%)  0 1/53 (1.89%)  1 0/47 (0.00%)  0 1/47 (2.13%)  1 1/54 (1.85%)  1 0/55 (0.00%)  0 1/52 (1.92%)  1 0/51 (0.00%)  0
Stares  1  0/48 (0.00%)  0 0/53 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 1/54 (1.85%)  1 2/55 (3.64%)  2 1/52 (1.92%)  1 1/51 (1.96%)  1
Uninterested  1  0/48 (0.00%)  0 1/53 (1.89%)  1 1/47 (2.13%)  1 1/47 (2.13%)  1 1/54 (1.85%)  1 2/55 (3.64%)  2 0/52 (0.00%)  0 1/51 (1.96%)  1
Drowsiness  1  1/48 (2.08%)  1 0/53 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 1/54 (1.85%)  1 0/55 (0.00%)  0 0/52 (0.00%)  0 2/51 (3.92%)  2
Sadness  1  0/48 (0.00%)  0 2/53 (3.77%)  2 1/47 (2.13%)  1 0/47 (0.00%)  0 0/54 (0.00%)  0 0/55 (0.00%)  0 0/52 (0.00%)  0 2/51 (3.92%)  2
Crying  1  1/48 (2.08%)  1 0/53 (0.00%)  0 1/47 (2.13%)  1 0/47 (0.00%)  0 2/54 (3.70%)  2 1/55 (1.82%)  1 0/52 (0.00%)  0 0/51 (0.00%)  0
Dizziness  1  0/48 (0.00%)  0 0/53 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 0/54 (0.00%)  0 0/55 (0.00%)  0 0/52 (0.00%)  0 1/51 (1.96%)  1
Tics  1  0/48 (0.00%)  0 0/53 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 0/54 (0.00%)  0 0/55 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0
Metabolism and nutrition disorders                 
Loss of Appetite  1  1/48 (2.08%)  1 4/53 (7.55%)  4 6/47 (12.77%)  6 3/47 (6.38%)  3 2/54 (3.70%)  2 5/55 (9.09%)  5 7/52 (13.46%)  7 6/51 (11.76%)  6
Psychiatric disorders                 
Insomnia or trouble sleeping  1  2/48 (4.17%)  2 2/53 (3.77%)  2 5/47 (10.64%)  5 3/47 (6.38%)  3 3/54 (5.56%)  3 7/55 (12.73%)  7 6/52 (11.54%)  6 4/51 (7.84%)  4
Euphoric  1  2/48 (4.17%)  2 0/53 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 2/54 (3.70%)  2 2/55 (3.64%)  2 0/52 (0.00%)  0 0/51 (0.00%)  0
Anxiety  1  0/48 (0.00%)  0 1/53 (1.89%)  1 0/47 (0.00%)  0 0/47 (0.00%)  0 0/54 (0.00%)  0 0/55 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, SERS

Due to early withdrawal or loss of contact during the study, the sample size for analysis was smaller.

The dosing design of the study may have led to more adverse events than would occur in clinic.

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. Mark Stein
Organization: Dept. of Psychiatry, University of Washington
Phone: 206-987-1161
EMail: mstein42@uw.edu
Layout table for additonal information
Responsible Party: Mark Stein, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00393042    
Other Study ID Numbers: CRIT124E US15
2006-0423
2006-04
First Submitted: October 25, 2006
First Posted: October 26, 2006
Results First Submitted: December 16, 2015
Results First Posted: April 19, 2017
Last Update Posted: April 19, 2017