Study Seeking Patients with ADHD with Aggression

  • STATUS
    Recruiting
  • sponsor
    Supernus
Updated on 25 March 2021

Summary

Study Seeking Patients with ADHD with Aggression

Description

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MOLINDONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS FOR THE TREATMENT OF IMPULSIVE AGGRESSION IN PEDIATRIC PATIENTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CONJUECTION WITH STANDARD ADHD TREATMENT

Details
Condition Attention Deficit/Hyperactivity Disorder (ADHD - Pediatric), *Healthy Children Studies
Clinical Study IdentifierTX148471
SponsorSupernus
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or Female 6-12 years old
Primary diagnosis of ADHD with impulsive aggression
Stabilized on monotherapy treatment with an optimized FDA-approved ADHD medication for at least one month
Weight of at least 20kg

Exclusion Criteria

A current or lifetime diagnosis of epilepsy, MDD, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette’s disorder, or psychosis not otherwise specified
Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder
Use of anticonvulsants, antidepressants, mood stabilizers, benzodiazepines, cholinesterase inhibitors within 2 weeks of Visit 2
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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