Clinical trial NCT00626236: Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Conduct Disorder
Keywords: ADHD and conduct problems
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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. 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.
4. IQ greater than 71.

Exclusion Criteria:

1. Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified.
2. Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder.
3. Any other anxiety disorder as primary diagnosis.
4. Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline.
5. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.

Primary outcomes:
measure: safety scales (Simpson-Angus, Barnes Akathisia, AIMS)
timeFrame: weekly for duration of treatment
Secondary outcomes:
measure: Nisonger Child Behavior Rating Form - TIQ
timeFrame: screening, then weekly and at final visit
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Shreveport
country: United States
facility: The Psychopharm Research Cntr - LSU Dept of Psychiatry
state: Louisiana
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Trials
state: Washington
Study officials:
affiliation: University Hospitals Case Medical Center/Case Western Reserve University
name: Robert Findling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stocks JD, Taneja BK, Baroldi P, Findling RL. A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems. J Child Adolesc Psychopharmacol. 2012 Apr;22(2):102-11. doi: 10.1089/cap.2011.0087. Epub 2012 Feb 28.