Attention Deficit Hyperactivity Disorder (ADHD), Fetal Alcohol Syndrome
Conditions
Keywords
fetal alcohol syndrome, attention deficit disorder, attention deficit disorder with hyperactivity, ADD, FAS, FASD, ADHD
Brief summary
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
Detailed description
Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity (ADHD) symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.
Interventions
DRUGAtomoxetine
Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.
Sponsors
Mark L. Wolraich
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Patient must have been between the ages of 4 and 11 years at the time of entry into the double blind study. * Patients must meet diagnostic criteria for FASD. * Patient must, at entry into doubleblind study, have met DSM-IV criteria for ADHD, any subtype. And must have an ADHDRS-IV score of \> or + 90% for age and gender on either subtest or total score for children above 5 years of age. * Patients will continue atomoxetine/placebo until entry nto this study. * History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study. * Patients must be able to swallow capsules. * Patients must be of a sufficient mental age (3 yrs) to participate in the study. * Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection. * Teacher must agree to cooperate with the study.
Exclusion criteria
* Have received an investigational medication other than atomoxetine in the previous 30 days. * Have significant current medical conditions that could be exacerbated or compromised by atomoxetine. * Have used MAOIs within one month prior to visit 1. * Patients with hypertension. * Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder. * Patients taking anticonvulsants for seizure control. * Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 1. * Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring. * Pubertal girls.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburg Side-Effects Scale: Trouble Sleeping | 12 months or study duration | Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation. |
| Pittsburg Side-Effects Scale: Hallucinations | 12 months or study duration | Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Loss of Appetite | 12 months or study duration | Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Motor Tics | 12 months or study duration | Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale-Buccal, Lingual Movements | 12 months or study duration | Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation. |
| Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers | 12 months or study duration | Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Worried/Anxious | 12 months or study duration | Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Dull/Tired/Listless | 12 months or study duration | Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Headaches | 12 months or study duration | Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Stomachaches | 12 months or study duration | Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Crabby/Irritable | 12 months or study duration | Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Tearful/Sad/Depressed | 12 months or study duration | Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
| Pittsburg Side-Effects Scale: Socially Withdrawn | 12 months or study duration | Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Growth While on Atomoxetine With Growth Before Entry Into Study. | 12 months or study duration | Height measured in centimeters at the time of each visit as part of the vital signs. |
| Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. | 12 months or study duration | Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior. |
Countries
United States
Participant flow
Recruitment details
The study the recruited 29 (21 male/8 female) children between 10/18/2006 and 9/21/2011. The children were recruited from a prior efficacy trial. Participants for the efficacy trial were drawn from physician referral resources, self-referral, and a pool of subjects identified for a study sponsored by the Center for Disease Control and Prevention.
Pre-assignment details
Two recruits declined particicpation in this open-label study. Participants continued to take atomoxetine/placeblo (depending on prior RCT assignment) until entry into this open label study.
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine HCL (Strattera) The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This titration will occur at each visit. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Atomoxetine HCL (Strattera) |
|---|---|
| Age, Categorical <=18 years | 27 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 7.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 19 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Pittsburg Side-Effects Scale-Buccal, Lingual Movements
Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.
Time frame: 12 months or study duration
Population: Attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale-Buccal, Lingual Movements | Visit 1 | .12 units on a scale | Standard Deviation 0.33 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale-Buccal, Lingual Movements | Visit 5 | 0.2 units on a scale | Standard Deviation 0.5 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale-Buccal, Lingual Movements | Visit 8 | 0.44 units on a scale | Standard Deviation 0.73 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale-Buccal, Lingual Movements | Visit 10 | 0.27 units on a scale | Standard Deviation 0.47 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.11, 0.39]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.23, 0.77]
Primary
Pittsburg Side-Effects Scale: Crabby/Irritable
Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One Subject in the RCT did not enroll in the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Crabby/Irritable | Visit 1 | 0.85 units on a scale | Standard Deviation 0.88 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Crabby/Irritable | Visit 5 | 0.68 units on a scale | Standard Deviation 0.85 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Crabby/Irritable | Visit 8 | 1.06 units on a scale | Standard Deviation 0.85 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Crabby/Irritable | Visit 10 | 0.73 units on a scale | Standard Deviation 0.65 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.28, 0.26]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.56, 0.52]
Primary
Pittsburg Side-Effects Scale: Dull/Tired/Listless
Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject from the RCT did not enter the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Dull/Tired/Listless | Visit 8 | 0.38 units on a scale | Standard Deviation 0.62 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Dull/Tired/Listless | Visit 10 | 0.36 units on a scale | Standard Deviation 0.5 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Dull/Tired/Listless | Visit 1 | 0.31 units on a scale | Standard Deviation 0.62 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Dull/Tired/Listless | Visit 5 | 0.36 units on a scale | Standard Deviation 0.57 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.36, 0.18]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.36, 0.18]
Primary
Pittsburg Side-Effects Scale: Hallucinations
Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject in the RCT did not enroll in the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Hallucinations | Visit 1 | 0.04 units on a scale | Standard Deviation 0.2 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Hallucinations | Visit 5 | 0.00 units on a scale | Standard Deviation 0 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Hallucinations | Visit 8 | 0.12 units on a scale | Standard Deviation 0.5 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Hallucinations | Visit 10 | 0.00 units on a scale | Standard Deviation 0 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.21, 0.32]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.21, 0.32]
Primary
Pittsburg Side-Effects Scale: Headaches
Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject from the RCT did not enter the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Headaches | Visit 1 | 0.23 units on a scale | Standard Deviation 0.51 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Headaches | Visit 5 | 0.40 units on a scale | Standard Deviation 0.82 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Headaches | Visit 8 | 0.31 units on a scale | Standard Deviation 0.6 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Headaches | Visit 10 | 0.18 units on a scale | Standard Deviation 0.4 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.2, 0.35]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.2, 0.35]
Primary
Pittsburg Side-Effects Scale: Loss of Appetite
Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject in the RCT did not enroll in the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Loss of Appetite | Visit 1 | 0.46 units on a scale | Standard Deviation 0.65 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Loss of Appetite | Visit 5 | 0.56 units on a scale | Standard Deviation 0.65 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Loss of Appetite | Visit 8 | 0.38 units on a scale | Standard Deviation 0.5 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Loss of Appetite | Visit 10 | 0.45 units on a scale | Standard Deviation 0.52 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.36, 0.13]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.72, 0.27]
Primary
Pittsburg Side-Effects Scale: Motor Tics
Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: Children with FAS participating in the extend safety efficacy study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Motor Tics | Visit 1 | 0.15 units on a scale | Standard Deviation 0.54 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Motor Tics | Visit 5 | 0.20 units on a scale | Standard Deviation 0.5 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Motor Tics | Visit 8 | 0.31 units on a scale | Standard Deviation 0.6 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Motor Tics | Visit 10 | 0.27 units on a scale | Standard Deviation 0.47 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.21, 0.3]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.42, 0.6]
Primary
Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: 27 IN PCT and one subject did not enroll in the safety efficacy study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers | Visit 1 | 0.42 units on a scale | Standard Deviation 0.7 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers | Visit 5 | 0.40 units on a scale | Standard Deviation 0.58 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers | Visit 8 | 0.62 units on a scale | Standard Deviation 0.89 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers | Visit 10 | 0.64 units on a scale | Standard Deviation 1.03 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.17, 0.36]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.17, 0.36]
Primary
Pittsburg Side-Effects Scale: Socially Withdrawn
Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject in the RCT did not enroll in the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Socially Withdrawn | Visit 5 | 0.16 units on a scale | Standard Deviation 0.47 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Socially Withdrawn | Visit 8 | 0.25 units on a scale | Standard Deviation 0.58 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Socially Withdrawn | Visit 10 | 0.09 units on a scale | Standard Deviation 0.3 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Socially Withdrawn | Visit 1 | 0.12 units on a scale | Standard Deviation 0.43 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.28, 0.24]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.57, 0.47]
Primary
Pittsburg Side-Effects Scale: Stomachaches
Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject in the RCT did not enroll in the Open Label Study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Stomachaches | Visit 1 | 0.23 units on a scale | Standard Deviation 0.51 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Stomachaches | Visit 5 | 0.36 units on a scale | Standard Deviation 0.49 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Stomachaches | Visit 8 | 0.25 units on a scale | Standard Deviation 0.58 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Stomachaches | Visit 10 | 0.45 units on a scale | Standard Deviation 0.82 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.24, 0.24]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.49, 0.49]
Primary
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject in RCT did not participate in the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Tearful/Sad/Depressed | Visit 1 | 0.19 units on a scale | Standard Deviation 0.4 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Tearful/Sad/Depressed | Visit 5 | 0.24 units on a scale | Standard Deviation 0.52 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Tearful/Sad/Depressed | Visit 8 | 0.50 units on a scale | Standard Deviation 0.63 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Tearful/Sad/Depressed | Visit 10 | 0.27 units on a scale | Standard Deviation 0.47 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.32, 0.2]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.64, 0.39]
Primary
Pittsburg Side-Effects Scale: Trouble Sleeping
Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.
Time frame: 12 months or study duration
Population: One subject participating in the RCT did not participate in the open label
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Trouble Sleeping | Visit 1 | 0.35 units on a scale | Standard Deviation 0.57 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Trouble Sleeping | Visit 5 | 0.64 units on a scale | Standard Deviation 0.7 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Trouble Sleeping | Visit 8 | 0.53 units on a scale | Standard Deviation 0.74 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Trouble Sleeping | Visit 10 | 0.40 units on a scale | Standard Deviation 0.52 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.19, 0.35]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.19, 0.35]
Primary
Pittsburg Side-Effects Scale: Worried/Anxious
Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Population: One subject from RCT did not enroll in the open label study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Worried/Anxious | Visit 1 | 0.27 units on a scale | Standard Deviation 0.45 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Worried/Anxious | Visit 5 | 0.24 units on a scale | Standard Deviation 0.6 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Worried/Anxious | Visit 8 | 0.56 units on a scale | Standard Deviation 0.63 |
| Atomoxetine HCL (Strattera) | Pittsburg Side-Effects Scale: Worried/Anxious | Visit 10 | 0.45 units on a scale | Standard Deviation 0.69 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.16, 0.4]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.16, 0.4]
Secondary
Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
Height measured in centimeters at the time of each visit as part of the vital signs.
Time frame: 12 months or study duration
Population: Measurements of height were not consistently obtained on all subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine HCL (Strattera) | Compare Growth While on Atomoxetine With Growth Before Entry Into Study. | Visit 1 | 121.67 cm | Standard Deviation 9.84 |
| Atomoxetine HCL (Strattera) | Compare Growth While on Atomoxetine With Growth Before Entry Into Study. | Visit 8 | 123.27 cm | Standard Deviation 4.01 |
| Atomoxetine HCL (Strattera) | Compare Growth While on Atomoxetine With Growth Before Entry Into Study. | Visit 10 | 132.13 cm | Standard Deviation 8.77 |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.69, 1.38]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-0.69, 1.38]
Secondary
Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.
Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.
Time frame: 12 months or study duration
Population: ADHD Parent Rating Scale
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atomoxetine HCL (Strattera) | Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. | Visit 1 | 37.35 units on a scale |
| Atomoxetine HCL (Strattera) | Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. | Visit 8 | 27.87 units on a scale |
| Atomoxetine HCL (Strattera) | Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period. | Visit 10 | 31.88 units on a scale |
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-7.76, -7.04]
Comparison: Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model.95% CI: [-3.03, -1.9]