Atomoxetine Pilot Study in Preschool Children With ADHD

NCT00517647 | Completed Phase 4

• 1 other identifier: HSC04-22
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if atomoxetine (a common brand name is Strattera), a medicine that is used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has given permission to study this drug in this age group.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; atomoxetine; preschool children; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• A reduction of 30% in the Hyperactive-Impulsive (HI) subscale scores of the Conners Rating Scale-Revised, which indicates an improvement in both efficacy and a significant clinical improvement in the child.

  7 to 13 weeks

Secondary Outcomes (1)

• Decrease in ADHD specific symptom severity and impairment

  7 to 13 weeks

Interventions

ATMX DRUG

Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child must be 36-69 months old at the time of screening to insure that the child can complete the short-term safety and efficacy trial before the age of 6 years.
• Child must have categorical and dimensional evidence of clinically significant ADHD symptoms in multiple settings that have been present for at least six months.
• ADHD symptoms must cause significant functional impairment in the child. Child must meet impairment scale threshold based on Children's Global Assessment Scale (C-GAS, Shaffer, Gould, Brasic et al., 1983) score \< 60.
• Child must have resided with primary caretaker for at least 6 months prior to the screening.
• Child's heart rate must be within the 98th percentile and blood pressure within the 95th percentile by age and gender and oral temperature values within the normal range.

You may not qualify if:

• Child is taking MAOI or there have been less than 2 weeks since it was discontinued.
• Concurrent treatment with other medications that have CNS effects or that affect performance (e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, lithium carbonate, sedating antihistamines, decongestant or sympathomimetics). Child should be off of previous psychotropic medications for a minimum duration of one week for stimulants, clonidine or guanfacine; two weeks for bupropion, tricyclic antidepressants, venlafaxine, SSRIs (except fluoxetine and citalopram), valproate; and three weeks for fluoxetine, citalopram, and neuroleptics.
• Child has narrow angle glaucoma.
• Child who has a major medical condition that would interfere with involvement in the study or would be affected negatively by ATMX (i.e., heart disease, high blood pressure, glaucoma, untreated or unstable hyperthyroidism, uncontrolled seizure disorder, or illnesses that would require hospitalization).
• Child with co-morbid psychiatric diagnoses of Major Depression, Bipolar Disorder, a psychotic disorder, or other psychiatric disorders in addition to ADHD that requires concurrent treatment with additional/alternative medication.
• Current history of physical, sexual, or emotional abuse.
• The patient has taken an investigational drug within the last 30 days.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Department of Psychiatry

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jaswinder K Ghuman, M.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: April 1, 2004
• Primary Completion: March 1, 2008
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

US (1)