Status:
COMPLETED
Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
Lead Sponsor:
Florida International University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
7-11 years
Phase:
NA
Brief Summary
This study will evaluate the effectiveness of an integrative group psychosocial therapy combined with stimulant medication in treating children with attention deficit hyperactivity disorder plus impai...
Detailed Description
There has been increasing recognition that many children with attention deficit hyperactivity disorder (ADHD) exhibit depressive and manic-like symptoms suggestive of major depressive disorder (MDD) a...
Eligibility Criteria
Inclusion
- ADHD combined subtype with evidence of depressive or manic-like symptoms, as assessed by CDRS, YMRS, and Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia, that persist after stimulant treatment
Exclusion
- Full Scale IQ less than 80
- Current seizure disorder or history of seizures requiring treatment or other significant neurological problems
- History of other medical problems for which stimulant treatment may involve considerable risk, including cardiac arrhythmias, hypertension, Tourette's disorder, or history of severe tic exacerbations caused by stimulant exposure (Note: child with uncomplicated tic disorders or a family history of tic disorders will not be excluded as stimulants are well tolerated in a majority of such cases)
- Meets full criteria for Type I or II bipolar disorder or any child manifesting mood symptoms (manic or depressive), such as significant suicidal ideation or psychotic symptoms that require emergent pharmacological treatment or hospitalization
- History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, post-traumatic stress disorder, sexual disorders, organic mental disorder, or eating disorder
- No longer manifests impairing manic/depressive symptoms after stimulant therapy based on CDRS-R greater than 27 or YMRS greater than 11 with Clinical Global Impressions-Severity 3 or greater
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00632619
Start Date
March 1 2009
End Date
September 1 2011
Last Update
May 21 2013
Active Locations (1)
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1
Center for Children and Families at Florida International University
Miami, Florida, United States, 33199