Status:
TERMINATED
Treatment of Children With ADHD Who do Not Fully Respond to Stimulants
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
We propose to do this with a single site, ten week, pilot study of 40 school age children, ages 6-17, with Attention-Deficit/ Hyperactivity Disorder (ADHD) and moderate or greater impairment (C-GAS \<...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00279409
Start Date
July 1 2006
End Date
February 1 2009
Last Update
June 19 2020
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032