Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD

NCT00918567 | Completed Phase 4 Results

• 1 other identifier: B4Z-US-X053
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Atomoxetine; Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• Rule Violations During Direct Classroom Observation at Endpoint (Week 8)

  Observations were conducted using the Student Behavior Teacher Response Observation Code. After learning the classroom rules, observers watched children in their classrooms for 30 minutes during an academic activity and recorded each time the subject violated a classroom rule. Total classroom rule violations were used as the primary outcome measures for the study.

  Endpoint (Week 8)

Secondary Outcomes (10)

• Impairment Rating Scale (Parent Completed) at Endpoint

  Endpoint (Week 8)

• Impairment Rating Scale (Teachers) at Endpoint

  Endpoint (Week 8)

• Pittsburgh Side Effects Rating Scale (PSERS)(Parent Completed) at Endpoint:

  Endpoint (Week 8)

• Pittsburgh Side Effects Rating Scale (PSERS)(Teacher Rated):

  at weeks 8 (Endpoint)

• Disruptive Behavior Disorders Rating Scale ODD Subscale (DBD- Parent Completed) at Endpoint

  Endpoint (Week 8)

Study Arms (2)

Combined therapy

EXPERIMENTAL

atomoxetine plus behavior therapy

Drug: atomoxetine; Behavioral: Behavior Modification Therapy

Drug therapy

ACTIVE COMPARATOR

atomoxetine alone

Drug: atomoxetine

Interventions

atomoxetine DRUG

open label treatment dosed up to 1.8mg/kg/day

Also known as: Drug Therapy

Combined therapy; Drug therapy

Behavior Modification Therapy BEHAVIORAL

8 week behavioral modification course with school consultation, parenting groups using COPE and child social skills group

Also known as: Behavior Therapy

Combined therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Cennter for Children and Families

Buffalo, New York, 14214, United States

Location

Related Publications (1)

• Waxmonsky JG, Waschbusch DA, Pelham WE, Draganac-Cardona L, Rotella B, Ryan L. Effects of atomoxetine with and without behavior therapy on the school and home functioning of children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 Nov;71(11):1535-51. doi: 10.4088/JCP.09m05496pur. Epub 2010 Jun 29.

  PMID: 20673557 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride; Drug Therapy; Behavior Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The primary limitation of this study was the lack of a control condition, thereby limiting our ability to detect the causality of observed improvements. Study may not have had sufficient subjects to detect group differences on secondary measures.

Results Point of Contact

• Title: James Waxmonsky M.D.
• Organization: SUNY Buffalo

jwaxmons@fiu.edu

305 348 3258

Study Officials

• James G Waxmonsky

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

• Daniel A Waschbusch

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: January 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 20, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-10

Locations

US (1)