Phase 4
N=56
Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00918567 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Rule Violations During Direct Classroom Observation at Endpoint (Week 8) — 6.15; 4.93 number occurences per 30 mins — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- atomoxetine (Drug); Behavior Modification Therapy (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rule Violations During Direct Classroom Observation at Endpoint (Week 8) |
6.15; 4.93 | <.05 sig |
| SECONDARY Impairment Rating Scale (Parent Completed) at Endpoint |
2.66; 2.84 | <.05 sig |
| SECONDARY Impairment Rating Scale (Teachers) at Endpoint |
2.02; 2.29 | <.05 sig |
| SECONDARY Pittsburgh Side Effects Rating Scale (PSERS)(Parent Completed) at Endpoint: |
.38; .34 | <.05 sig |
| SECONDARY Pittsburgh Side Effects Rating Scale (PSERS)(Teacher Rated): |
.23; .21 | <.05 sig |
| SECONDARY Disruptive Behavior Disorders Rating Scale ODD Subscale (DBD- Parent Completed) at Endpoint |
.90; 1.12 | >.05 |
| SECONDARY Disruptive Behavior Disorder Rating Scale ODD Subscale(DBD- Teacher Completed) at Endpoint |
.54; .71 | <.05 sig |
| SECONDARY Social Skills Rating Scale Problem Behavior Subscale(SSRS Parent) at Endpoint |
16.48; 19.53 | <0.05 sig |
| SECONDARY Social Skills Rating Scale Problem Behavior Subscale(SSRS Teachers) at Endpoint |
13.88; 13.96 | <.05 sig |
| SECONDARY ADHD Subscale of the DBD (Parent Completed) at Endpoint |
1.07; 1.47 | <.05 sig |
| SECONDARY ADHD Subscale of the DBD (Teacher Completed) at Endpoint |
1.01; 1.13 | <.05 sig |
Summary
Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However, children are typically referred for treatment because of "real life" problems in functioning, not symptoms (Pelham, Fabiano, & Massetti, 2005). While ATX has been found to produce functional improvements at home, the Weiss study found limited results in this area at school.
Furthermore, almost no research has examined the effects of combining ATX and behavior therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of hyperactivity/impulsivity and increased the number of subjects reaching optimal response (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve functional performance in the classroom. The effects of combined therapy may be even larger for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.
Objective: The primary objective was to evaluate the effects of ATX alone and in combination with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed using traditional symptoms measures as well as functional measures of academic and behavioral improvements in the classroom.
Eligibility Criteria
Inclusion Criteria
- meet DSM-IV diagnostic criteria for ADHD-combined type;
- estimated IQ of 75 or higher;
- agree to comply with the randomly assigned treatment condition;
- enrolled in full time school at first grade level or higher; AND
- have a primary teacher available to complete ratings for the entire study duration.
Exclusion Criteria
- current or past history of seizures (not including benign febrile seizures) or other neurological disorders;
- physical conditions that preclude administration of Strattera or other medical illness that might confound study results or increase the safety risk to subjects exposed to study treatments (i.e. marked cardiac conduction delay, etc.);
- prior failed trial of Strattera defined as 3 weeks or more on a daily dose of Strattera of at least .8mg/kg or a documented inability to tolerate at least .8mg/kg/day;
- serious forms of psychopathology other than ADHD, such autism, bipolar disorder, schizophrenia or any other psychopathology requiring urgent treatment with psychotropic medication; OR
- children for whom discontinuation of their current psychotropic medication would represent a serious risk to themselves or others.
The presence of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD) or learning disabilities will not result in exclusion from the study as they are commonly occurring comorbidities that have not been found to moderate response to ADHD treatments (Jensen et al., 2001). Enrollment in special education services will also not be an exclusionary criteria as work by this research group has found that such services do not affect response to ADHD treatments (Niemic, Fabiano, Pelham, & Fuller, 2002).
Data sourced from ClinicalTrials.gov (NCT00918567). 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.