N/A
Completed N=68
Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00632619 ↗
Enrolled (actual)
68
Serious AEs
7.7%
Results posted
May 2013
Primary outcomePrimary: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe — 17.33; 13.82 units on a scale — p=0.015
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 impairments in mood.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe |
17.33; 13.82 | 0.015 sig |
| SECONDARY Young Mania Rating Scale (YMRS) Score |
10.08; 8.58 | 0.106 |
| SECONDARY Disruptive Behavior Disorder Scale Score for ADHD Symptoms |
25.5; 25.10 | 0.38 |
| SECONDARY Children's Depression Rating Scale-Revised (CDRS-R) Total Score |
28.20; 25.10 | 0.016 sig |
| SECONDARY Disruptive Behavior Disorder Scale Score for ODD Symptoms |
11.13; 10.31 | 0.095 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00632619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.