Treatment of Children With ADHD Who do Not Fully Respond to Stimulants

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.

Key facts

Study ID

NCT00279409

Run by

New York State Psychiatric Institute

People needed

10

Starts

2006-07-01

Expected to finish

2009-02-01

Last updated by the study team

2020-06-19

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English or Spanish speaking parent/guardian. Parent/guardian and child must be able to understand the protocol.
• Primary diagnosis of ADHD despite treatment with a stimulant by the primary care treatment provider.
• Non-responder or partial responder to stimulant treatment. ADHD symptoms and clinical impairment despite treatment with stimulant (including OROS-MPH [Concerta] or mixed salts amphetamine [Adderall]).
• IQ of greater than 70.
• The subject must be in school.
• The family must be able to attend weekly visits.

You may not qualify if…

• Unable to understand protocol or follow study procedures.
• Subject doing well on stimulants.
• Subjects showing lack of response or minimal response to stimulants due to non-compliance with taking medication or taking suboptimal doses.
• Autism, Psychosis, Bipolar Disorder, Drug Abuse, significant suicidality, or any other psychiatric disorder (such as MDD, Anxiety Disorders, Eating Disorders) in addition to ADHD that will require treatment with additional medication or therapy.
• The subject is using or abusing recreational drugs or has a positive urine toxicology screen (except for stimulants).
• The subject has a history of physical, sexual, or emotional abuse that resulted in a clinically significant impact on clinical presentation, potentially driving some of the symptoms of ADHD.
• Females who are pregnant or breast-feeding or who have a positive urine pregnancy test.
• Sexually active females and males who do not agree to use adequate birth control.
• Abnormal cardiac function.
• Subject is taking prohibited concomitant medication during phase 1 or phase 2 of the trial.

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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