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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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 "non-responders" to standard stimulant treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: Bristol-Myers Squibb; National Institute of Mental Health (NIMH); Otsuka Pharmaceutical Co., Ltd.
• Treatments: Aripiprazole; Central Nervous System Stimulants

Criteria

Inclusion Criteria:

1. English or Spanish speaking parent/guardian. Parent/guardian and child must be able to understand the protocol.

2. Primary diagnosis of ADHD despite treatment with a stimulant by the primary care treatment provider.

3. 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]).

4. IQ of greater than 70.

5. The subject must be in school.

6. The family must be able to attend weekly visits.

Exclusion Criteria:

1. Unable to understand protocol or follow study procedures.

2. Subject doing well on stimulants.

3. Subjects showing lack of response or minimal response to stimulants due to non-compliance with taking medication or taking suboptimal doses.

4. 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.

5. The subject is using or abusing recreational drugs or has a positive urine toxicology screen (except for stimulants).

6. 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.

7. Females who are pregnant or breast-feeding or who have a positive urine pregnancy test.

8. Sexually active females and males who do not agree to use adequate birth control.

9. Abnormal cardiac function.

10. Subject is taking prohibited concomitant medication during phase 1 or phase 2 of the trial.