Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

Study Overview
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Brief Summary
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It is hypothesized that, when given at the lowest effective dose, the favorable side effect profile combined with it's lower propensity for weight gain would make SPN-810 a candidate for treatment of persistent serious conduct problems in pediatric subjects with ADHD.

Official Title
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A Randomized, Multicenter, Parallel Group, Dose-Ranging Study to Evaluate the Safety and Tolerability of SPN-810 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Persistent Serious Conduct Problems

Conditions
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Attention Deficit Disorder With Hyperactivity, Conduct Disorder

Intervention / Treatment
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* Drug: SPN-810
* Drug: SPN-810
* Drug: SPN-810
* Drug: SPN-810


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pediatric male or female subjects, age 6 to 12 years. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD. NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people. IQ greater than 71. Exclusion Criteria: Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified. Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder. Any other anxiety disorder as primary diagnosis. Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br> | Drug: SPN-810<br>* capsule taken three times a day<br>|
| Experimental: Treatment 2<br> | Drug: SPN-810<br>* capsule taken TID<br>|
| Experimental: Treatment 3<br> | Drug: SPN-810<br>* capsule taken TID<br>|
| Experimental: Treatment 4<br> | Drug: SPN-810<br>* capsule taken TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety scales (Simpson-Angus, Barnes Akathisia, AIMS) |  | weekly for duration of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nisonger Child Behavior Rating Form - TIQ |  | screening, then weekly and at final visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD and conduct problems