A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | October 2012 |
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and
safety study in children with impulsive aggression comorbid with
Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and
female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120
subjects will be randomized across approximately 30 US centers to one of four treatment
groups.
safety study in children with impulsive aggression comorbid with
Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and
female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120
subjects will be randomized across approximately 30 US centers to one of four treatment
groups.
Inclusion Criteria:
1. Healthy pediatric male or female subjects, age 6 to 12 years.
2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR)
diagnosis of ADHD.
3. R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
4. IQ greater than 71.
5. Weight of >=20kg
6. current treatment with psychostimulant (1 month prior to screening)
We found this trial at
27
sites
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