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Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD (B4Z-MC-X017)

Primary Purpose

Fetal Alcohol Syndrome, Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Strattera

Placebo

About this trial

This is an interventional treatment trial for Fetal Alcohol Syndrome focused on measuring attention deficit hyperactivity disorder, ADHD, fetal alcohol syndrome, FAS, FASD, atomoxetine hcl

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient must be between the ages of 4 and 11 years at the time of entry into the study.
Patients must meet diagnostic criteria for FASD
Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of > or = to 90%ile for age and gender for either subtest or total score if greater than 5 years of age.
Patients who enter the study at visit 1 taking stimulant medication must be medication-free for at least 24 hours before visit 2.
History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study.
Patients must be able to swallow capsules.
Patients must be of a sufficient developmental level (~3 yrs) to participate in the study.
Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection.
Teacher must agree to cooperate with the study. Children less than 6 years old must have completed a course of PCIT and still meet DSM-IV criteria for ADHD.

Exclusion Criteria:

Have received an in investigational medication in the past 30 days.
Are currently on a medication treatment that is effective (ADHDRS-IV score within 1 SD of average) and well tolerated.
Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
Have used MAOIs within one month prior to visit 2.
Patients with hypertension.
Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder.
Patients taking anticonvulsants for seizure control.
Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 2.
Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring.
Pubertal girls.

Sites / Locations

OU Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Atomoxetine HCL (Strattera)

Outcomes

Primary Outcome Measures

ADHD Rating Scale - IV

Secondary Outcome Measures

Determine if atomoxetine is safe and well tolerated by children with FAS.

Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo.

Determine if atomoxetine improves behaviors in the mornings and evenings.

Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.

Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine.

Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI)

Full Information

NCT ID

NCT00417794

First Posted

January 2, 2007

Last Updated

April 6, 2017

Sponsor

University of Oklahoma

Collaborators

Mark L. Wolraich, M.D., Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00417794

Brief Title

Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD

Acronym

B4Z-MC-X017

Official Title

A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

April 22, 2015 (Actual)

Study Completion Date

April 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

Collaborators

Mark L. Wolraich, M.D., Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.

Detailed Description

Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fetal Alcohol Syndrome, Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)

Keywords

attention deficit hyperactivity disorder, ADHD, fetal alcohol syndrome, FAS, FASD, atomoxetine hcl

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Atomoxetine HCL (Strattera)

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Strattera

Other Intervention Name(s)

atomoxetine HCL

Intervention Description

escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.

Primary Outcome Measure Information:

Title

ADHD Rating Scale - IV

Time Frame

length of protocol

Secondary Outcome Measure Information:

Title

Determine if atomoxetine is safe and well tolerated by children with FAS.

Time Frame

length of protocol

Title

Time Frame

length of protocol

Title

Determine if atomoxetine improves behaviors in the mornings and evenings.

Time Frame

Length of protocol

Title

Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.

Time Frame

Length of protocol

Title

Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine.

Time Frame

Length of protocol

Title

Time Frame

Length of protocol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient must be between the ages of 4 and 11 years at the time of entry into the study. Patients must meet diagnostic criteria for FASD Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of > or = to 90%ile for age and gender for either subtest or total score if greater than 5 years of age. Patients who enter the study at visit 1 taking stimulant medication must be medication-free for at least 24 hours before visit 2. History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study. Patients must be able to swallow capsules. Patients must be of a sufficient developmental level (~3 yrs) to participate in the study. Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection. Teacher must agree to cooperate with the study. Children less than 6 years old must have completed a course of PCIT and still meet DSM-IV criteria for ADHD. Exclusion Criteria: Have received an in investigational medication in the past 30 days. Are currently on a medication treatment that is effective (ADHDRS-IV score within 1 SD of average) and well tolerated. Have significant current medical conditions that could be exacerbated or compromised by atomoxetine. Have used MAOIs within one month prior to visit 2. Patients with hypertension. Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder. Patients taking anticonvulsants for seizure control. Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 2. Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring. Pubertal girls.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura J McGuinn, PhD

Organizational Affiliation

University of Oklahoma

Official's Role

Principal Investigator

Facility Information:

Facility Name

OU Child Study Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73117

Country

United States

12. IPD Sharing Statement

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Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD

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