Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
Attention Deficit Disorder with Hyperactivity, Guanfacine, Event Related Potentials
Brief summary
All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained.
Detailed description
All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained. Our hypotheses are: A) GXR will be superior to placebo at reducing symptoms of ADHD as measured by standardized clinical diagnostic tools by week 3 of treatment. B) Compared to placebo and pretreatment measures, GXR at week 4 of treatment will increase the amplitude of the right frontal N200 and frontal-central P300, and such changes will correlate with clinical response.
Interventions
Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.
DRUGPlacebo
Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.
Sponsors
Shire
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 6-12 years * Meet criteria for Attention Deficit Hyperactivity Disorder
Exclusion criteria
* Do not meet criteria for Major Depression, Bipolar, Autism * Talking any psychotropic medication for a condition other than ADHD * History of epilepsy, severe head injury or loss of consciousness * History of Intolerance to guanfacine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dupaul ADHD Rating Scale | Baseline and Follow up | 54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression- Improvement | Week 4 of study | Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 4/2010 through 6/2011 primarily through flyers in child psychiatry clinics and by informing families who called the clinic intake line.
Pre-assignment details
After diagnostic assessment and confirmation that subjects meet study criteria, subjects were scheduled for a baseline EEG and they performed the Stop Signal Task while ERP data was obtained. 42 subjects completed baseline evaluation,13 did not complete baseline EEG, leaving 29 to be randomized to drug
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). | 13 |
| Guanfacine Extended Release Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). | 16 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 7 |
Baseline characteristics
| Characteristic | Guanfacine Extended Release | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 13 Participants | 29 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 7.8 years STANDARD_DEVIATION 1.2 | 8.78 years STANDARD_DEVIATION 1.8 | 8.29 years STANDARD_DEVIATION 1.5 |
| Region of Enrollment United States | 16 participants | 13 participants | 29 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 13 | 10 / 16 |
| serious Total, serious adverse events | 0 / 13 | 0 / 16 |
Outcome results
Primary
Dupaul ADHD Rating Scale
54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.
Time frame: Baseline and Follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Dupaul ADHD Rating Scale | 31.4 units on a scale | Standard Deviation 16.5 |
| Guanfacine | Dupaul ADHD Rating Scale | 13.6 units on a scale | Standard Deviation 9.7 |
Secondary
Clinical Global Impression- Improvement
Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse
Time frame: Week 4 of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Clinical Global Impression- Improvement | 3.0 units on a scale | Standard Deviation 1.1 |
| Guanfacine | Clinical Global Impression- Improvement | 2.0 units on a scale | Standard Deviation 0.5 |