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CompletedNCT00418262B4Z-US-050Updated Jul 2, 2017Results posted

Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD

A Phase 3 interventional study of Atomoxetine in Fetal Alcohol Syndrome and Attention Deficit Hyperactivity Disorder (ADHD), sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by University of Oklahoma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
4 Years to 11 Years
Sex
All
01

Study summary

Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Read the 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 (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.

02

Conditions studied

  • Fetal Alcohol Syndrome
  • Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

  • fetal alcohol syndrome
  • attention deficit disorder
  • attention deficit disorder with hyperactivity
  • ADD
  • FAS
  • FASD
  • ADHD
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 27 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient must have been between the ages of 4 and 11 years at the time of entry into the double blind study.
  • Patients must meet diagnostic criteria for FASD.
  • Patient must, at entry into doubleblind study, have met DSM-IV criteria for ADHD, any subtype. And must have an ADHDRS-IV score of > or + 90% for age and gender on either subtest or total score for children above 5 years of age.
  • Patients will continue atomoxetine/placebo until entry nto this study.
  • 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 mental age (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.

Exclusion criteria

Exclusion Criteria:

  • Have received an investigational medication other than atomoxetine in the previous 30 days.
  • Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
  • Have used MAOIs within one month prior to visit 1.
  • 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 1.
  • Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring.
  • Pubertal girls.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Atomoxetine HCL (Strattera)

    Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)

    Drug: Atomoxetine

Interventions

  • DrugAtomoxetine

    Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.

    Also known as: Brand Name: Strattera, Serial Number: 76306506, ACT

06

What researchers measure

Primary outcomes

  1. Pittsburg Side-Effects Scale: Motor Tics

    Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  2. Pittsburg Side-Effects Scale-Buccal, Lingual Movements

    Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.

    Time frame: 12 months or study duration

  3. Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers

    Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  4. Pittsburg Side-Effects Scale: Worried/Anxious

    Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  5. Pittsburg Side-Effects Scale: Dull/Tired/Listless

    Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  6. Pittsburg Side-Effects Scale: Headaches

    Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  7. Pittsburg Side-Effects Scale: Stomachaches

    Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  8. Pittsburg Side-Effects Scale: Crabby/Irritable

    Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  9. Pittsburg Side-Effects Scale: Tearful/Sad/Depressed

    Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  10. Pittsburg Side-Effects Scale: Socially Withdrawn

    Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  11. Pittsburg Side-Effects Scale: Hallucinations

    Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  12. Pittsburg Side-Effects Scale: Loss of Appetite

    Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

    Time frame: 12 months or study duration

  13. Pittsburg Side-Effects Scale: Trouble Sleeping

    Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.

    Time frame: 12 months or study duration

Secondary outcomes

  1. Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.

    Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.

    Time frame: 12 months or study duration

  2. Compare Growth While on Atomoxetine With Growth Before Entry Into Study.

    Height measured in centimeters at the time of each visit as part of the vital signs.

    Time frame: 12 months or study duration

07

Results

Posted Jul 2, 2017
Limitations and caveats
There were a limited number of subjects because of difficulties in recruiting children with FAS and ADHD within the age group studied. We were only able to obtain a small number of teacher rating scales.

Participant flow

The study the recruited 29 (21 male/8 female) children between 10/18/2006 and 9/21/2011. The children were recruited from a prior efficacy trial. Participants for the efficacy trial were drawn from physician referral resources, self-referral, and a pool of subjects identified for a study sponsored by the Center for Disease Control and Prevention.

Visits 1 (Baseline) Thru 5
Participant flow — Visits 1 (Baseline) Thru 5
MilestoneAtomoxetine HCL (Strattera)
Started27
Completed25
Not completed2
Visits 5 Thru 8
Participant flow — Visits 5 Thru 8
MilestoneAtomoxetine HCL (Strattera)
Started25
Completed16
Not completed9
Visits 8 Thru 10
Participant flow — Visits 8 Thru 10
MilestoneAtomoxetine HCL (Strattera)
Started16
Completed11
Not completed5

Outcome measures

PrimaryPittsburg Side-Effects Scale: Motor Tics

Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Motor Tics
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.15 ± 0.54
Visit 50.20 ± 0.50
Visit 80.31 ± 0.60
Visit 100.27 ± 0.47
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.05 · 95% CI -0.21 to 0.30This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.11 · 95% CI -0.42 to 0.60This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale-Buccal, Lingual Movements

Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale-Buccal, Lingual Movements
units on a scaleAtomoxetine HCL (Strattera)
Visit 1.12 ± .33
Visit 50.2 ± 0.50
Visit 80.44 ± 0.73
Visit 100.27 ± 0.47
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.12 · 95% CI -0.11 to 0.39This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.24 · 95% CI -0.23 to 0.77This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers

Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.42 ± 0.70
Visit 50.40 ± 0.58
Visit 80.62 ± 0.89
Visit 100.64 ± 1.03
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.10 · 95% CI -0.17 to 0.36This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.10 · 95% CI -0.17 to 0.36This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Worried/Anxious

Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Worried/Anxious
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.27 ± 0.45
Visit 50.24 ± 0.60
Visit 80.56 ± 0.63
Visit 100.45 ± 0.69
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.13 · 95% CI -0.16 to 0.40This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.13 · 95% CI -0.16 to 0.40This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Dull/Tired/Listless

Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Dull/Tired/Listless
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.31 ± 0.62
Visit 50.36 ± 0.57
Visit 80.38 ± 0.62
Visit 100.36 ± 0.50
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.07 · 95% CI -0.36 to 0.18This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.07 · 95% CI -0.36 to 0.18This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Headaches

Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Headaches
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.23 ± 0.51
Visit 50.40 ± 0.82
Visit 80.31 ± 0.60
Visit 100.18 ± 0.40
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.04 · 95% CI -0.20 to 0.35This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.04 · 95% CI -0.20 to 0.35This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Stomachaches

Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Stomachaches
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.23 ± 0.51
Visit 50.36 ± 0.49
Visit 80.25 ± 0.58
Visit 100.45 ± 0.82
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.03 · 95% CI -0.24 to 0.24This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.06 · 95% CI -0.49 to 0.49This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Crabby/Irritable

Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Crabby/Irritable
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.85 ± 0.88
Visit 50.68 ± 0.85
Visit 81.06 ± 0.85
Visit 100.73 ± 0.65
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.00 · 95% CI -0.28 to 0.26This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.01 · 95% CI -0.56 to 0.52This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Tearful/Sad/Depressed

Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.19 ± 0.40
Visit 50.24 ± 0.52
Visit 80.50 ± 0.63
Visit 100.27 ± 0.47
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.06 · 95% CI -0.32 to 0.20This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Median difference (net): -0.12 · 95% CI -0.64 to 0.39This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Socially Withdrawn

Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Socially Withdrawn
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.12 ± 0.43
Visit 50.16 ± 0.47
Visit 80.25 ± 0.58
Visit 100.09 ± 0.30
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.05 · 95% CI -0.28 to 0.24This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.09 · 95% CI -0.57 to 0.47This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Hallucinations

Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Hallucinations
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.04 ± 0.20
Visit 50.00 ± 0.00
Visit 80.12 ± 0.50
Visit 100.00 ± 0.00
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.07 · 95% CI -0.21 to 0.32This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.07 · 95% CI -0.21 to 0.32This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Loss of Appetite

Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Loss of Appetite
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.46 ± .65
Visit 50.56 ± 0.65
Visit 80.38 ± 0.50
Visit 100.45 ± 0.52
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.11 · 95% CI -0.36 to 0.13This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): -0.22 · 95% CI -0.72 to 0.27This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
PrimaryPittsburg Side-Effects Scale: Trouble Sleeping

Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Pittsburg Side-Effects Scale: Trouble Sleeping
units on a scaleAtomoxetine HCL (Strattera)
Visit 10.35 ± 0.57
Visit 50.64 ± 0.70
Visit 80.53 ± 0.74
Visit 100.40 ± 0.52
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.08 · 95% CI -0.19 to 0.35This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.08 · 95% CI -0.19 to 0.35This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
SecondaryDetermine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.

Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.

Time frame:
12 months or study duration
Reported as:
Mean · units on a scale
Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.
units on a scaleAtomoxetine HCL (Strattera)
Visit 137.35 (32.64 to 42.35)
Visit 827.87 (23.52 to 32.26)
Visit 1031.88 (24.94 to 38.63)
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): -7.40 · 95% CI -7.76 to -7.04This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): -2.44 · 95% CI -3.03 to -1.90This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.
SecondaryCompare Growth While on Atomoxetine With Growth Before Entry Into Study.

Height measured in centimeters at the time of each visit as part of the vital signs.

Time frame:
12 months or study duration
Reported as:
Mean · cm
Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
cmAtomoxetine HCL (Strattera)
Visit 1121.67 ± 9.84
Visit 8123.27 ± 4.01
Visit 10132.13 ± 8.77
Statistical analysis
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.39 · 95% CI -0.69 to 1.38This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.
  • Atomoxetine HCL (Strattera) · Mean difference (net): 0.39 · 95% CI -0.69 to 1.38This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atomoxetine HCL (Strattera)0/26 (0%)0/26 (0%)19/26 (73.1%)
Most frequent other events
Showing 10 of 19
Most frequent other events
EventAtomoxetine HCL (Strattera)
CoughRespiratory, thoracic and mediastinal disorders9/26
VomitingGastrointestinal disorders8/26
HeadacheNervous system disorders8/26
StomachacheGastrointestinal disorders7/26
Sleepy or Sleep TroubleNervous system disorders7/26
Nasal Congestion or RhinorrheaGeneral disorders6/26
IrritabilityPsychiatric disorders4/26
EnuresisRenal and urinary disorders4/26
FeverGeneral disorders4/26
Upper Respiratory or Sinus InfectionInfections and infestations4/26

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Atomoxetine HCL (Strattera)
<=18 years27
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Atomoxetine HCL (Strattera)
Mean7.4 (4.3 to 12.0)
Sex: Female, Male
Sex: Female, Male(Participants)Atomoxetine HCL (Strattera)
Female8
Male19
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Atomoxetine HCL (Strattera)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White15
More than one raceNA
Unknown or Not Reported9
Region of Enrollment
Region of Enrollment(participants)Atomoxetine HCL (Strattera)
United States27
08

Study locations

1 site
  • OU Child Study Center
    Oklahoma City, Oklahoma 73117, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00418262
Lead sponsor
University of Oklahoma
Collaborators
Mark L. Wolraich
Responsible party
Laura J McGuinn, MD (Principal Investigator, University of Oklahoma) — Principal investigator
First posted
Jan 4, 2007
Start date
Aug 2005
Primary completion
Apr 22, 2015
Completion
Apr 22, 2015
Results posted
Jul 2, 2017
Last update
Jul 2, 2017

Study contacts

Laura J McGuinn, M.D.
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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