Trial Outcomes & Findings for Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood (NCT NCT00632619)
NCT ID: NCT00632619
Last Updated: 2013-05-21
Results Overview
averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
measured at week 12 (endpoint)
Results posted on
2013-05-21
Participant Flow
Subjects were recruited as two cohorts- 50% in each wave. Wave one was recruited in Buffalo NY in the summer of 2009, from referrals from local pediatricians and therapists and mailings to families. The study was then moved to Florida International University where the second cohort was recruited from 9/10 to 12/10 using similar procedures.
Subjects were assessed at intake on the current ADHD medication regimen to make sure that they needed additional treatment beyond what they were currently receiving. There was no washout prior to enrollment.
Participant milestones
| Measure |
Medication and Community Treatment Group
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
35
|
|
Overall Study
COMPLETED
|
25
|
31
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
Baseline characteristics by cohort
| Measure |
Medication and Community Treatment Group
n=33 Participants
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=35 Participants
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
9.4 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
9.3 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
9.3 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
35 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: measured at week 12 (endpoint)Population: all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.
averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.
Outcome measures
| Measure |
Medication and Community Treatment Group
n=25 Participants
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=31 Participants
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe
|
17.33 units on a scale
Standard Deviation 7.29
|
13.82 units on a scale
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: Measured at weeks 12 (endpoint)Population: all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.
rates manic like symptoms in children; 7 items ranging from 0-4 and 4 items on a 0-8 scale; higher scores indicate more severe symptom severity (min total score=0, max=60). There are no subscales. Symptom severity information is obtained from direct interview of parent and child. It was initially selected as the primary outcome but prior to commencement of data collection the Mood Severity Index (MSI) was chosen instead based on recently published work in a related study (see above).
Outcome measures
| Measure |
Medication and Community Treatment Group
n=25 Participants
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=31 Participants
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS) Score
|
10.08 units on a scale
Standard Deviation 4.65
|
8.58 units on a scale
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: Measured at Week12 (endpoint)Population: all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.
sum of severity rating for all 18 DSM (Diagnostic and Statistics Manual for Mental Disorders) IV ADHD symptoms and two from DSM 3R on a 0 to 3 scale obtained from parent rating; range is from 0 to 60 with higher numbers indicating more severe symptoms
Outcome measures
| Measure |
Medication and Community Treatment Group
n=25 Participants
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=31 Participants
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Disruptive Behavior Disorder Scale Score for ADHD Symptoms
|
25.5 units on a scale
Standard Deviation 10.94
|
25.10 units on a scale
Standard Deviation 9.12
|
SECONDARY outcome
Timeframe: Measured at Week 12 (endpoint)Population: all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.
rates 17 items of depression on a severity scale using information obtained from parent and child. Higher numbers indicate more severity symptoms and range is from 17 to 113.
Outcome measures
| Measure |
Medication and Community Treatment Group
n=25 Participants
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=31 Participants
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Children's Depression Rating Scale-Revised (CDRS-R) Total Score
|
28.20 units on a scale
Standard Deviation 6.46
|
25.10 units on a scale
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: week 12 (endpoint)Population: all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.
parents rating all DSM symptoms of Oppositional Defiant Disorder on a 0-3 severity scale with higher scores indicating more severe symptoms and range is from 0-27 (8 DSM IV items and I item from DSM 3R)
Outcome measures
| Measure |
Medication and Community Treatment Group
n=25 Participants
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=31 Participants
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Disruptive Behavior Disorder Scale Score for ODD Symptoms
|
11.13 units on a scale
Standard Deviation 6.22
|
10.31 units on a scale
Standard Deviation 4.73
|
Adverse Events
Medication and Community Treatment Group
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Medication and Novel Therapy Group
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medication and Community Treatment Group
n=30 participants at risk
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=35 participants at risk
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
0.00%
0/30 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
2.9%
1/35 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Psychiatric disorders
threat of self injurious behavior
|
3.3%
1/30 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
0.00%
0/35 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Gastrointestinal disorders
appendix removed
|
0.00%
0/30 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
2.9%
1/35 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Psychiatric disorders
aggression towards other
|
0.00%
0/30 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
2.9%
1/35 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Psychiatric disorders
expresssed suicial ideation
|
0.00%
0/30 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
2.9%
1/35 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
Other adverse events
| Measure |
Medication and Community Treatment Group
n=30 participants at risk
Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
|
Medication and Novel Therapy Group
n=35 participants at risk
Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
|
|---|---|---|
|
Psychiatric disorders
worried/anxious
|
10.0%
3/30 • Number of events 3 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
17.1%
6/35 • Number of events 6 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Skin and subcutaneous tissue disorders
picking at skin, fingers, nails, lips
|
20.0%
6/30 • Number of events 6 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
17.1%
6/35 • Number of events 6 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Nervous system disorders
repetitive movements/motor tics
|
3.3%
1/30 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
8.6%
3/35 • Number of events 3 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
General disorders
dull/tired
|
6.7%
2/30 • Number of events 2 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
2.9%
1/35 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Gastrointestinal disorders
stomachaches
|
3.3%
1/30 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
5.7%
2/35 • Number of events 2 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Psychiatric disorders
crabby or irritable
|
16.7%
5/30 • Number of events 5 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
25.7%
9/35 • Number of events 9 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
General disorders
loss of appetite
|
16.7%
5/30 • Number of events 5 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
17.1%
6/35 • Number of events 6 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
General disorders
insomnia
|
10.0%
3/30 • Number of events 3 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
17.1%
6/35 • Number of events 6 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Psychiatric disorders
tearful/sad affect
|
6.7%
2/30 • Number of events 2 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
2.9%
1/35 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
|
Psychiatric disorders
dull or tired looking
|
6.7%
2/30 • Number of events 2 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
2.9%
1/35 • Number of events 1 • for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe. The suicide item from the CDRS was used to systematically measure suicidal ideation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place