Phase 4
Completed N=29
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT01069523 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Dupaul ADHD Rating Scale — 31.4; 13.6 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dupaul ADHD Rating Scale |
31.4; 13.6 | — |
| SECONDARY Clinical Global Impression- Improvement |
3.0; 2.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01069523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.