Attention Deficit Disorder With HyperactivityPhase 2NCT00626236

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

A Phase 2 study testing SPN-810 in people with Attention Deficit Disorder With Hyperactivity and Conduct Disorder, run by Supernus Pharmaceuticals, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Attention Deficit Disorder With Hyperactivity, Conduct Disorder
What is being tested?: SPN-810
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 9 sitesUnited States
Study dates: 21 Oct 2008to 23 Sep 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Northwest Clinical Trials
Bellevue, Washington, 98004
Florida Clinical Research Center
Bradenton, Florida, 32408
Sarkis Clinical Trials
Gainesville, Florida, 32607
Capstone Clinical Research
Libertyville, Illinois, 60048
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
IPS Research
Oklahoma City, Oklahoma, 73103
CNS Healthcare
Orlando, Florida, 32806
Alliance Research Group
Richmond, Virginia, 23229
The Psychopharm Research Cntr - LSU Dept of Psychiatry
Shreveport, Louisiana, 71103

Other trials in United States

About this study

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

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.

Read the 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
Being tested: SPN-810
Keywords: ADHD and conduct problems
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Conduct Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPN-810Drug
Also called molindone
1.67mg capsule taken TID
SPN-810Drug
Also called molindone
3.33mg capsule taken TID
SPN-810Drug
Also called molindone
5mg capsule taken TID
SPN-810Drug
Also called molindone
6.67 mg capsule taken TID

Study groups in NCT00626236
Study group	Role	What they receive
Treatment 1	Experimental	Treatment 1: SPN-810 5mg/day for subjects <30kg and 10mg/day for subjects ≥30kg Receives: Drug: SPN-810
Treatment 2	Experimental	Treatment 2: SPN-810 10mg/day for subjects <30kg and 20mg/day for subjects ≥30kg. Receives: Drug: SPN-810
Treatment 3	Experimental	Treatment 3: SPN-810 15mg/day for subjects <30kg and 30mg/day for subjects ≥30kg. Receives: Drug: SPN-810
Treatment 4	Experimental	Treatment 4: SPN-810 20mg/day for subjects <30kg and 40mg/day for subjects ≥30kg. Receives: Drug: SPN-810

What is being measured

The primary outcome is the main question the study is designed to answer.

The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score
The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).
Measured: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Secondary outcomes (5)

The Changes From Baseline in the CGI-S
The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subject's global functioning prior to and after the administration of study medication. The severity of illness (CGI-S) is rated by the investigator on a 7-point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). A lower overall score in subsequent testing indicates successful therapy.
Measured: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Clinical Global Impression - Improvement Scale (CGI-I)
Clinical Global Impression Scale. CGI-I is measured relative to the condition at the Baseline on a 7-point scale with 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A lower overall score in subsequential testing indicates successful treatment. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).
Measured: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV ADHD Inattention
The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #0-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the inattention subscale, the scores range from 0-27, the higher the score, the worse the outcome.
A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.
Measured: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity
The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the Hyperactivity/Impulsivity subscale, the scores range from 0-27, the higher the score, the worse the outcome.
A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.
Measured: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales - ADHD Combined
The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the combined subscale, the scores range from 0-54, the higher the score, the worse the outcome.
A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.
Measured: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 200823 Sep 2009

First posted29 Feb 2008 (estimated)
Study start21 Oct 2008
Primary completion23 Sep 2009
Study completion23 Sep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00626236
Sponsor's protocol ID: 810P201
Status last verified: Aug 2025
First submitted: 20 Feb 2008
Last updated: 9 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 22372512

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Disorder With Hyperactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00626236
Acronym / sponsor ID: 810P201
Conditions: Attention Deficit Disorder With Hyperactivity, Conduct Disorder
Keywords: ADHD and conduct problems
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 21 Oct 2008 (actual)
Primary completion: 23 Sep 2009 (actual)
Study completion: 23 Sep 2009 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 16 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment 1	Experimental	Drug: SPN-810Treatment 1: SPN-810 5mg/day for subjects <30kg and 10mg/day for subjects ≥30kg
Treatment 2	Experimental	Drug: SPN-810Treatment 2: SPN-810 10mg/day for subjects <30kg and 20mg/day for subjects ≥30kg.
Treatment 3	Experimental	Drug: SPN-810Treatment 3: SPN-810 15mg/day for subjects <30kg and 30mg/day for subjects ≥30kg.
Treatment 4	Experimental	Drug: SPN-810Treatment 4: SPN-810 20mg/day for subjects <30kg and 40mg/day for subjects ≥30kg.

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPN-810Also: molindone1.67mg capsule taken TID	Drug	Treatment 1
SPN-810Also: molindone3.33mg capsule taken TID	Drug	Treatment 2
SPN-810Also: molindone5mg capsule taken TID	Drug	Treatment 3
SPN-810Also: molindone6.67 mg capsule taken TID	Drug	Treatment 4

Primary outcome

The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).

5 secondary outcomes

The Changes From Baseline in the CGI-S
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Clinical Global Impression - Improvement Scale (CGI-I)
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV ADHD Inattention
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales - ADHD Combined
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Results and safety

Results posted to the registry on 16 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment 1 5/10mg TDD	20	14
Treatment 2 10/20mg TDD	19	12
Treatment 3 15/30mg TDD	19	15
Treatment 4 20/40mg TDD	20	14

Primary outcome: The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score

Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks). Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment 1 5/10mg TDD n = 20	Treatment 2 10/20mg TDD n = 19	Treatment 3 15/30mg TDD n = 19	Treatment 4 20/40mg TDD n = 20
Mean Score at Baseline	20.4 (5.22)	25.7 (6.98)	26.0 (5.51)	26.0 (7.63)
Visit 2 Change from Baseline	-0.6 (5.82)	-3.3 (5.94)	-2.6 (6.69)	-3.3 (5.72)
Visit 3 Change from Baseline	-0.6 (5.82)	-7.1 (9.95)	-3.4 (6.78)	-6.1 (6.69)
Visit 4 Change from Baseline	-0.6 (5.82)	-7.1 (9.95)	-5.0 (9.57)	-8.9 (6.95)
Visit 5 Change from Baseline	-0.6 (5.82)	-7.1 (9.95)	-5.0 (9.57)	-11.7 (7.68)
Visit 6 Change from Baseline	-2.7 (5.38)	-7.8 (9.60)	-6.4 (9.31)	-11.6 (7.51)
Visit 7 Change from Baseline	-4.8 (6.07)	-8.1 (9.79)	-7.6 (8.71)	-12.9 (8.35)
Visit 8 Change from Baseline	-6.0 (7.19)	-7.6 (8.37)	-9.0 (9.84)	-14.5 (9.24)

Population analysed: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment 1 5/10mg TDD	0 of 20 (0%)	12 of 20 (60%)	0 of 20
Treatment 2 10/20mg TDD	0 of 19 (0%)	15 of 19 (78.9%)	0 of 19
Treatment 3 15/30mg TDD	1 of 19 (5.3%)	17 of 19 (89.5%)	0 of 19
Treatment 4 20/40mg TDD	1 of 20 (5%)	17 of 20 (85%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22372512Stocks 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.
A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problemsLink provided by the sponsor.

Related trials for Attention Deficit Disorder With Hyperactivity

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Findling, MD principal investigator

University Hospitals Case Medical Center/Case Western Reserve University

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SPN-810 in people with Attention Deficit Disorder With Hyperactivity and Conduct Disorder, run by Supernus Pharmaceuticals, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score (time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00626236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.