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Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?

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ClinicalTrials.gov Identifier: NCT01127607
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Florida International University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition ADHD
Intervention Drug: lisdexamfetamine
Enrollment 38
Recruitment Details Participants were recruited by direct advertisement as well as from referrals from mental health and medical providers.
Pre-assignment Details Participants first stabilized on LDX in 3 week open label trial starting at 30mg + increasing by 20mg/week until optimal dose was found. Those unable to tolerate LDX or not responsive to it were discontinued. 38 enrolled; 8 dropped out due to adverse events + 3 were lost to follow up in med phase, leaving 27.
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period 1). The 14 subjects assigned to this arm were then switched to blinded placebo for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only placebo during period II. All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period I). The 13 subjects assigned to this arm were then switched to blinded optimal dose of LDX for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only their optimal dose of LDX during period II.
Period Title: Phase I (Within Subjects)
Started 14 13
Completed 14 13
Not Completed 0 0
Period Title: Phase II (Between Subjects)
Started 14 13
Completed 13 11
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             0             2
Withdrawal by Subject             1             0
Arm/Group Title Placebo Arm Treatment Arm Total
Hide Arm/Group Description Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial. Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
Adult participant was first stabilized on LDX during a 3 week open label titration. 11 participants dropped out during med titration phase (8 due to adverse events and 3 lost to follow-up; a 12th dropped out after group assignment but prior to receiving blinded phase II medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
13
 100.0%
27
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
41.38  (4.41) 40.69  (6.06) 41.04  (5.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
11
  78.6%
9
  69.2%
20
  74.1%
Male
3
  21.4%
4
  30.8%
7
  25.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 27 participants
14 13 27
1.Primary Outcome
Title Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts
Hide Description Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.
Arm/Group Title Placebo - Homework Task Placebo - Non-academic Task Medication - Homework Task Medication Non-academic Task
Hide Arm/Group Description:
Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Overall Number of Participants Analyzed 13 13 10 10
Mean (Standard Deviation)
Unit of Measure: behaviors
Verbalizations 67.2  (35.4) 42.1  (16.2) 53.8  (31.6) 40.1  (24.0)
Commands 14.5  (8.8) 9.0  (4.2) 11.0  (6.6) 4.9  (3.3)
inappropriate child behavior 6.8  (6.2) 1.4  (2.5) 3.8  (4.7) 1.5  (1.9)
2.Primary Outcome
Title Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages
Hide Description Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.
Arm/Group Title Placebo - Homework Task Placebo - Non-academic Task Medication - Homework Task Medication Non-academic Task
Hide Arm/Group Description:
Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Overall Number of Participants Analyzed 13 13 10 10
Mean (Standard Deviation)
Unit of Measure: Percentage of behaviors
Parent praise 1.2  (2.2) 6.0  (6.0) 2.8  (2.5) 5.7  (6.2)
Parent negative talk 5.3  (4.3) 5.9  (8.6) 21.1  (21.0) 12.6  (10.2)
Parent demandingness 21.8  (8.9) 23.5  (10.9) 21.7  (10.1) 12.7  (6.5)
Parent impatient 42.4  (11.3) 38.7  (20.7) 34.1  (12.9) 26.3  (11.0)
Parent responsive 69.8  (33.3) 89.7  (18.1) 63.8  (35.8) 77.3  (18.8)
3.Secondary Outcome
Title Alabama Parenting Questionnaire (APQ)
Hide Description

measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.

Within subject comparison of no medication baseline vs. optimal dose medication.

Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Used a within-subjects evaluation; the same 24 participants evaluated in both arms.
Arm/Group Title Unmedicated Optimal Dose of Medication
Hide Arm/Group Description:
Data collected at intake, when participants were not on medication
Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Parent Involvement 37.83  (5.64) 38.82  (5.30)
Positive parenting 25.42  (3.60) 25.58  (2.86)
Poor monitoring and poor supervision 14.25  (3.84) 13.58  (3.20)
Inconsistent discipline 15.79  (3.51) 14.62  (3.87)
Corporal punishment 4.79  (2.04) 4.42  (1.72)
4.Secondary Outcome
Title Disruptive Behavior Disorders Rating Scale (DBD)
Hide Description Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Used a within-subjects design; the same 24 participants measured in both arms.
Arm/Group Title Unmedicated Optimal Dose of Medication
Hide Arm/Group Description:
Data collected at intake, when participants were not on medication
Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ADHD-hyperactive/impulsive symptom score 1.55  (0.76) 1.34  (0.61)
ADHD-inattentive symptom score 2.11  (0.59) 1.85  (0.74)
ODD symptom score 1.17  (0.69) 1.12  (0.69)
CD symptom score 0.16  (0.14) 0.18  (0.24)
5.Secondary Outcome
Title Impairment Rating Scale (IRS)
Hide Description Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by "no problems / no need for treatment" and at the high end by "extreme problem / definitely needs treatment." Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Uses a within-subjects evaluation; the same 25 participants are in both arms.
Arm/Group Title Unmedicated Optimal Dose of Medication
Hide Arm/Group Description:
Data collected at intake, when participants were not on medication
Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a 0 to 6 scale
Child's peer relationship impairment 2.75  (2.15) 2.21  (1.69)
Child's sibling relationship impairment 2.82  (2.34) 2.68  (1.99)
Child's parent relationship impairment 3.67  (1.88) 3.79  (1.56)
Child's academic impairment 3.75  (2.13) 3.29  (2.03)
Child's self-esteem impairment 3.92  (1.95) 3.54  (1.72)
Child's family impairment 4.00  (1.83) 3.87  (1.49)
Child's overall impairment 3.63  (1.86) 3.42  (1.59)
6.Secondary Outcome
Title Sheehan Disability Scale (SDS)
Hide Description The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Uses a within-subjects design; the same 25 participants are in both arms.
Arm/Group Title Unmedicated Optimal Dose of Medication
Hide Arm/Group Description:
Data collected at intake, when participants were not on medication
Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a 0 to 10 scale
6.26  (2.11) 3.17  (2.65)
7.Secondary Outcome
Title Dyadic Parent-Child Interaction Coding System (DPICS)
Hide Description Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.
Time Frame weeks 4 and weeks 5 (period I within subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Used a within-subjects design for this phase; the same 26 participants completed all four arms.
Arm/Group Title Placebo - Homework Task Placebo - Non-academic Task Medication - Homework Task Medication Non-academic Task
Hide Arm/Group Description:
Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Overall Number of Participants Analyzed 26 26 26 26
Mean (Standard Deviation)
Unit of Measure: behaviors
Verbalizations 61.7  (30.9) 58.2  (31.1) 45.2  (21.1) 48.6  (26.5)
Commands 15.4  (11.5) 14.8  (10.3) 8.7  (5.2) 8.3  (4.1)
inappropriate child behavior 6.1  (10.0) 3.3  (4.9) 2.5  (2.1) 3.8  (5.4)
8.Secondary Outcome
Title Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages
Hide Description Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.
Time Frame weeks 4 and weeks 5 (period I within subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Used a within-subjects design; the same 26 participants completed all arms.
Arm/Group Title Placebo - Homework Task Placebo - Non-academic Task Medication - Homework Task Medication Non-academic Task
Hide Arm/Group Description:
Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
Overall Number of Participants Analyzed 26 26 26 26
Mean (Standard Deviation)
Unit of Measure: Percentage of behaviors
Parent praise 2.6  (3.7) 3.0  (4.5) 3.6  (5.8) 2.2  (2.5)
Parent negative talk 4.7  (5.7) 4.0  (3.6) 14.4  (11.7) 9.1  (8.7)
Parent demandingness 24.1  (10.7) 25.7  (11.3) 19.3  (6.4) 19.2  (10.5)
Parent impatient 39.2  (12.8) 42.5  (18.7) 31.2  (15.7) 32.6  (10.4)
Parent responsive 83.2  (25.9) 74.8  (30.4) 75.9  (15.3) 79.8  (12.8)
9.Secondary Outcome
Title Pittsburgh Side Effect Rating Scale
Hide Description rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization.
Time Frame baseline and end of dose optimization phase/week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Within-subjects analysis; same 26 participants are in the unmedicated and optimal dose of medication arms.
Arm/Group Title Unmedicated Optimal Dose of Medication
Hide Arm/Group Description:
baseline; participants not on medication
Optimal dose of lisdexamfetamine (30 mg, 50 mg, or 70 mg) as selected by a three week open medication titration trial.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.04  (0.12) 0.26  (0.21)
10.Secondary Outcome
Title Adult ADHD Rating Scale (ADHD RS)
Hide Description measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Inattention 17.85  (8.21) 8.82  (6.54)
Hyperactive/Impulsive 14.77  (8.23) 5.64  (5.07)
Total Score 32.62  (15.61) 14.46  (10.91)
11.Secondary Outcome
Title Parenting Stress Index (PSI)--Total Stress
Hide Description measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
241.54  (47.33) 262.67  (38.84)
12.Secondary Outcome
Title Parenting Locus of Control (PLC)
Hide Description self completed parenting measure of the degree to which parents feel they can influence their child’s behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 ("strongly disagree") to 5 ("strongly agree"). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.00  (4.22) 80.00  (5.57)
13.Secondary Outcome
Title Brown Attention Deficit Scale (BAADS)
Hide Description Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 ("never") to 3 ("almost daily"). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: t score
Activation Scale t-score 73.38  (11.52) 66.4  (13.5)
Attention Scale t-score 75.54  (11.90) 65.10  (11.19)
Effort scale t-score 72.46  (15.56) 61.20  (10.98)
Affect scale t-score 63.46  (15.37) 53.20  (5.57)
Memory scale t-score 74.38  (63.90) 13.79  (13.58)
Total scale t-score 76.08  (14.79) 63.30  (70.52)
14.Secondary Outcome
Title Social Skills Rating System (SSRS)
Hide Description Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 ("never") to 2 ("often").At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: standard scores
Social Skills Total Standard Score 86.64  (17.72) 89.90  (13.68)
Problem Behavior Total Standard Score 113.81  (12.54) 111.80  (16.55)
15.Secondary Outcome
Title Disruptive Behavior Disorder Rating Scale (DBD)
Hide Description measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12).
Time Frame study endpoint- end of period II (between subjects trial)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Inattention 1.64  (0.76) 1.60  (0.39)
Hyperactive/Impulsive 1.25  (0.66) 1.09  (0.62)
Oppositional-defiant 1.04  (0.56) 0.76  (0.54)
Conduct disorder 0.17  (0.23) 0.15  (0.16)
16.Secondary Outcome
Title Impairment Rating Scale (IRS)
Hide Description measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child’s problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
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participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Impairment with peers 2.62  (2.02) 2.20  (2.04)
Impairment with siblings 2.17  (2.21) 2.30  (1.89)
Impairment interferes with parents' relationship 3.15  (1.57) 3.10  (1.85)
Academic impairment 3.15  (2.23) 2.60  (2.07)
Self-esteem impairment 3.00  (2.04) 3.40  (1.96)
General family impairment 3.08  (1.85) 2.90  (1.85)
Overall severity 2.62  (1.66) 2.70  (1.64)
17.Secondary Outcome
Title Sheehan Disability Scale (SDS)
Hide Description The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
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participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.36  (2.60) 2.26  (1.90)
18.Secondary Outcome
Title ADHD Severity Clinical Global Impressions Severity Subscale
Hide Description clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
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participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.78  (1.24) 2.36  (0.81)
19.Secondary Outcome
Title Barkley Home Situations Questionnaire (HSQ)
Hide Description Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
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Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: number of child problems endorsed
9.30  (4.67) 8.67  (5.22)
20.Secondary Outcome
Title Pittsburgh Side Effect Rating Scale Mean Severity Rating.
Hide Description rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.28  (0.10) 0.26  (0.12)
21.Secondary Outcome
Title Resting Blood Pressure
Hide Description Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: mm Hg
systolic BP 123.40  (8.90) 122.33  (11.45)
diastolic BP 76.10  (8.74) 75.11  (7.98)
22.Secondary Outcome
Title Alabama Parenting Questionnaire (APQ)
Hide Description

measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.

At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Positive parenting 24.85  (3.46) 24.33  (3.77)
Parental involvement 39.38  (5.38) 37.78  (4.55)
Poor monitoring/supervision 12.23  (3.14) 12.33  (2.40)
Inconsistent discipline 12.46  (3.84) 14.22  (2.86)
Corporal punishment use 4.69  (1.80) 3.89  (1.17)
23.Secondary Outcome
Title Impairment Rating Scale (IRS)
Hide Description self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 13 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Impairment with peers 2.38  (1.50) 1.91  (1.70)
Impairment with parents 2.46  (2.03) 1.30  (1.64)
General family impairment 2.77  (1.88) 2.27  (1.79)
Academic impairment 3.60  (2.88) 1.83  (2.04)
Self-esteem impairment 2.77  (2.09) 2.00  (1.84)
Overall impairment 3.00  (1.73) 2.55  (1.75)
24.Secondary Outcome
Title Weight
Hide Description Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: kg
76.0  (24.78) 69.62  (17.71)
25.Secondary Outcome
Title Resting Pulse
Hide Description measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).
Time Frame study endpoint- end of period II (between subjects trial)
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[Not Specified]
Arm/Group Title Placebo Arm Treatment Arm
Hide Arm/Group Description:
participants in this arm treated with matching placebo for 4 weeks duration
participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: bpm
74.44  (7.58) 77.13  (4.19)
26.Secondary Outcome
Title Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More
Hide Description Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).
Time Frame end of medication optimization phase/week 4
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Within-subjects analysis; data entered per dose not per subject. For example, if subject 1 took 30mg, 50mg and 70mgdoses during titration, they are recorded as three separate entries. Sample size reduces as dose increases because participants stopped at lowest acceptable dose and only moved to higher dose if they did not meet optimization criteria.
Arm/Group Title No Medication 30 mg Lisdexamfetamine 50 mg Lisdexamfetamine 70 mg Lisdexamfetamine
Hide Arm/Group Description:
The PSERS was completed at intake by all 38 participants who consented and met eligibility criteria in order to assess pre-medication rates of side effects. This was done because the PSERS measures commonly occurring events such as insomnia and irritability that can be seen in unmedicated patients with ADHD.
This arm includes all participants who were prescribed the 30mg dose and completed at least one side effect rating for this dose.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study which is why this cell size is larger than for the randomized controlled comparison that followed it.
This group includes all participants who were prescribed the 50mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg dose and are therefore included in that group as well.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study.
This group includes all participants who were prescribed the 70mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg and 50mg doses and are therefore included in those groups as well. Not all participants who were prescribed this dose were optimized to this dose.
Overall Number of Participants Analyzed 38 36 21 17
Measure Type: Number
Unit of Measure: Percent of participants
Motor tics 0 0 0 11.8
Buccal-lingual movement 2.6 19.4 28.6 23.5
picking at skin 13.2 11.1 14.3 5.9
worried/anxious 13.2 36.1 14.3 17.6
dull, tired, listless 10.5 16.7 9.5 11.8
headaches 5.3 36.1 28.6 29.4
stomachaches 0.0 16.7 4.8 29.4
crabby, irritiable 10.5 27.8 23.8 23.5
tearful, sad, depressed 7.9 13.9 19.0 11.8
socially withdrawn 5.3 8.3 0.0 0.0
loss of appetite 0.0 52.8 66.7 70.6
trouble sleeping 10.5 30.6 33.3 35.3
dry mouth 0.0 30.6 38.1 70.5
27.Secondary Outcome
Title Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase
Hide Description Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.
Time Frame baseline and end of med optimization phase/week 4
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Uses a within-subjects design; the same 27 participants are in both arms.
Arm/Group Title Unmedicated Optimal Dose of Medication
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Data collected at intake, when participants were not on medication
Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Inattention Symptoms 23.12  (3.58) 9.77  (4.44)
Hyperactive/Impulsive Symptoms 17.81  (5.73) 8.00  (5.08)
Total symptoms 40.85  (7.55) 17.77  (8.51)
Time Frame Adverse event data reported for period II (mean duration 8 weeks). While 27 total subjects were randomized to a treatment arm (med vs.placebo), 1 withdrew before med was dispensed which is why we have side effect data for 26 and not 27.
Adverse Event Reporting Description Pittsburgh Side Effect Scale (PSERS) was given at every visit to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe). The Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicide risk. It was given at every visit. Both measures were self completed.
 
Arm/Group Title Placebo Arm Treatment Arm All Participants in Period 1 Prescribed 30mg All Participants in Period 1 Prescribed 50mg All Participants in Period 1 Prescribed 70mg
Hide Arm/Group Description subjects in this arm treated only with blinded placebo for duration of assessment (period II- between subjects trial).One participant assigned to placebo dropped out before medication was dispensed for period II which is why the side effect data only has a total of 13 and not 14 subjects. subjects in this arm (N=13) only treated with blinded optimal dose of LDX (either 30mg, 50mg or 70mg) for duration of assessment (period II between subjects trial).

During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.

All 36 participants who were dispensed the 30mg dose and completed at least one Pittsburgh Side Effect Rating Scale (PSERS) are included in this category.

During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.

21 of 36 participants were dispensed the 50mg dose.

During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.

17 of 36 participants were dispensed the 70mg dose.

All-Cause Mortality
Placebo Arm Treatment Arm All Participants in Period 1 Prescribed 30mg All Participants in Period 1 Prescribed 50mg All Participants in Period 1 Prescribed 70mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Arm Treatment Arm All Participants in Period 1 Prescribed 30mg All Participants in Period 1 Prescribed 50mg All Participants in Period 1 Prescribed 70mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)      0/36 (0.00%)      0/21 (0.00%)      0/17 (0.00%)    
Psychiatric disorders           
suicidal ideation  [1]  0/13 (0.00%)  0 0/11 (0.00%)  0 0/36 (0.00%)  0 0/21 (0.00%)  0 0/17 (0.00%)  0
self harm attempt  [2]  0/13 (0.00%)  0 0/11 (0.00%)  0 0/36 (0.00%)  0 0/21 (0.00%)  0 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Every participant completed the Columbia Suicide Severity Rating Scale (CSSRS) at each visit. It assess suicidal ideation and self harm attempts including preparatory and interrupted attempts.
[2]
Measured at each visit using the self completed CSSRS.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Arm Treatment Arm All Participants in Period 1 Prescribed 30mg All Participants in Period 1 Prescribed 50mg All Participants in Period 1 Prescribed 70mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/13 (38.46%)      5/13 (38.46%)      34/36 (94.44%)      18/21 (85.71%)      15/17 (88.24%)    
Endocrine disorders           
dry mouth  [1]  1/13 (7.69%)  1 3/13 (23.08%)  3 11/36 (30.56%)  11 8/21 (38.10%)  8 12/17 (70.59%)  12
Gastrointestinal disorders           
stomachache  [2]  0/13 (0.00%)  0 0/13 (0.00%)  0 6/36 (16.67%)  6 1/21 (4.76%)  1 5/17 (29.41%)  5
General disorders           
fatigue  [2]  2/13 (15.38%)  2 1/13 (7.69%)  1 6/36 (16.67%)  6 2/21 (9.52%)  2 2/17 (11.76%)  2
appetite decrease  [2]  2/13 (15.38%)  2 3/13 (23.08%)  3 19/36 (52.78%)  19 14/21 (66.67%)  14 12/17 (70.59%)  12
insomnia  [2]  4/13 (30.77%)  4 3/13 (23.08%)  3 11/36 (30.56%)  11 7/21 (33.33%)  7 6/17 (35.29%)  6
Musculoskeletal and connective tissue disorders           
knee pain  [3]  0/13 (0.00%)  0 1/13 (7.69%)  1 0/36 (0.00%)  0 0/21 (0.00%)  0 0/17 (0.00%)  0
Nervous system disorders           
Buccal Lingual Movements  [4]  2/13 (15.38%)  2 0/13 (0.00%)  0 7/36 (19.44%)  7 6/21 (28.57%)  6 4/17 (23.53%)  4
picking at skin  [2]  2/13 (15.38%)  2 0/13 (0.00%)  0 4/36 (11.11%)  4 3/21 (14.29%)  3 1/17 (5.88%)  1
headache  [2]  0/13 (0.00%)  0 1/13 (7.69%)  1 13/36 (36.11%)  13 6/21 (28.57%)  6 5/17 (29.41%)  5
motor tic  [2]  0/13 (0.00%)  0 0/13 (0.00%)  0 0/36 (0.00%)  0 0/21 (0.00%)  0 2/17 (11.76%)  2
Psychiatric disorders           
anxious/jittery  [2]  3/13 (23.08%)  3 3/13 (23.08%)  3 13/36 (36.11%)  13 3/21 (14.29%)  3 3/17 (17.65%)  3
irritability  [2]  1/13 (7.69%)  1 3/13 (23.08%)  3 10/36 (27.78%)  10 5/21 (23.81%)  5 4/17 (23.53%)  4
depressed mood  [2]  0/13 (0.00%)  0 1/13 (7.69%)  1 5/36 (13.89%)  5 4/21 (19.05%)  4 2/17 (11.76%)  2
socially withdrawn  [2]  0/13 (0.00%)  0 0/13 (0.00%)  0 3/36 (8.33%)  3 0/21 (0.00%)  0 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
This event was spontaneously reported. It is not listed on the PSERS.refers to participants report of experiencing decreased salivation or a sense of "dry mouth"
[2]
Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
[3]
This event was spontaneously reported. It is not listed on the PSERS.
[4]
Pittsburgh Side Effect Scale (PSERS):Pittsburgh Side Effect Scale (PSERS) was given at baseline and endpoint to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe).
This study was limited by its small sample size. The validity and psychometrics of DPICS in adolescents is not well established, but removal of the adolescents had little impact on study results and actually strengthened some observed effects.
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. James Waxmonsky
Organization: Florida International University
Phone: 717 531 8646
EMail: jwaxmons@fiu.edu
Layout table for additonal information
Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT01127607     History of Changes
Other Study ID Numbers: IITWW#2
First Submitted: May 19, 2010
First Posted: May 21, 2010
Results First Submitted: January 6, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014