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

NCT ID: NCT00626236

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-21
• Study Completion Date: 2009-09-23

Brief Summary

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.

Detailed Description

This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male or female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD with persistent serious conduct problems. To determine eligibility for the study, subjects will undergo an initial screening visit. Seventy-two subjects will be randomized in the study; assuming a 17% dropout rate, it is anticipated that 60 subjects will complete the study. The study will consist of a Screening Period (within 28 days prior to the first dose administration), a Titration Period of 2 to 5 weeks, a Maintenance Period of 6 weeks, and a Safety Follow-up, which will be performed 30 days after the final study visit. The total subject duration in the study will be 16 to 19 weeks depending on the treatment group assignment. The total study duration is anticipated to be 15.5 months. A total of 72 subjects will be randomized based on weight at baseline, to 1 of 4 treatment groups.

Conditions

Attention Deficit Disorder With Hyperactivity; Conduct Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment 1

Treatment 1: SPN-810 5mg/day for subjects \<30kg and 10mg/day for subjects ≥30kg

Group Type: EXPERIMENTAL

SPN-810

Intervention Type: DRUG

1.67mg capsule taken TID

Treatment 2

Treatment 2: SPN-810 10mg/day for subjects \<30kg and 20mg/day for subjects ≥30kg.

Group Type: EXPERIMENTAL

SPN-810

Intervention Type: DRUG

3.33mg capsule taken TID

Treatment 3

Treatment 3: SPN-810 15mg/day for subjects \<30kg and 30mg/day for subjects ≥30kg.

Group Type: EXPERIMENTAL

SPN-810

Intervention Type: DRUG

5mg capsule taken TID

Treatment 4

Treatment 4: SPN-810 20mg/day for subjects \<30kg and 40mg/day for subjects ≥30kg.

Group Type: EXPERIMENTAL

SPN-810

Intervention Type: DRUG

6.67 mg capsule taken TID

Interventions

SPN-810

1.67mg capsule taken TID

Intervention Type: DRUG

SPN-810

3.33mg capsule taken TID

Intervention Type: DRUG

SPN-810

5mg capsule taken TID

Intervention Type: DRUG

SPN-810

6.67 mg capsule taken TID

Intervention Type: DRUG

Other Intervention Names

molindone; molindone; molindone; molindone

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Findling, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Case Medical Center/Case Western Reserve University

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22372512 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/22372512/

A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems

Other Identifiers

810P201

Identifier Type: -

Identifier Source: org_study_id