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New drug SPN-810 tested for kids with ADHD and severe behavior issues

NCT ID NCT00626236

Symptom relief Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested four different doses of SPN-810 (molindone) in 78 children aged 6 to 12 with ADHD and serious conduct problems. The main goal was to see if the drug is safe and tolerable. Researchers measured behavior changes using a special rating scale. The trial is complete, but results are not yet widely available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPN-810 (molindone)
What this could lead to
If successful, this could point toward a new treatment option for children with ADHD who also have severe conduct problems.
What could go wrong
This was a small, early-phase trial (phase 2) with only 78 children. It focused on safety and tolerability, not on proving the drug works. The results may not apply to all children, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

78 people

The number who actually took part.

Started

Oct 2008

Finished

Sep 2009

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder conduct disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Attention deficit disorder with hyperactivity Conduct disorder

Contacts and locations

Locations

  • Alliance Research Group

    Richmond, Virginia, 23229, United States

  • CNS Healthcare

    Orlando, Florida, 32806, United States

  • Capstone Clinical Research

    Libertyville, Illinois, 60048, United States

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119, United States

  • Florida Clinical Research Center

    Bradenton, Florida, 32408, United States

  • IPS Research

    Oklahoma City, Oklahoma, 73103, United States

  • Northwest Clinical Trials

    Bellevue, Washington, 98004, United States

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607, United States

  • The Psychopharm Research Cntr - LSU Dept of Psychiatry

    Shreveport, Louisiana, 71103, United States

More trials for these conditions

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