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N/A Completed N=70 Randomized Double-blind Treatment

Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder

Source: ClinicalTrials.gov NCT00399763 ↗
Enrolled (actual)
70
Serious AEs
2.9%
Results posted
Jul 2015
Primary outcomePrimary: Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist — 18.61; 18.19 units on a scale

Summary

The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
18.61; 18.19
SECONDARY
Time Line Followback Interview (TLFB)
-2.24; -5.78
SECONDARY
Side Effect Form for Children and Adolescents (SEFCA)
1; 1

Eligibility Criteria

Inclusion Criteria

  • Age 12-19
  • Provided assent/consent
  • attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
  • Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist <=22
  • At least one non-nicotine substance use disorder (SUD) by KSADS
  • Plans to live locally for 4 months
  • Willing to participate in cognitive behavioral therapy (CBT)

Exclusion Criteria

  • No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
  • No allergy to atomoxetine
  • No narrow angle glaucoma
  • No serious medical illness
  • Not pregnant
  • Not unwilling to use an effective form of contraception during the trial
  • No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00399763). 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. Informational only — not medical advice.

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