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

Completed · Phase 2

Conditions studied: Attention Deficit Disorder With Hyperactivity, Conduct Disorder

In brief

The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.

Key facts

Study ID

NCT00626236

Run by

Supernus Pharmaceuticals, Inc.

People needed

78

Starts

2008-10-21

Expected to finish

2009-09-23

Last updated by the study team

2025-12-09

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Florida Clinical Research Center — Bradenton, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• CNS Healthcare — Orlando, Florida, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• The Psychopharm Research Cntr - LSU Dept of Psychiatry — Shreveport, Louisiana, United States
• IPS Research — Oklahoma City, Oklahoma, United States
• Clinical Neuroscience Solutions, Inc. — Memphis, Tennessee, United States
• Alliance Research Group — Richmond, Virginia, United States
• Northwest Clinical Trials — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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