Official Title: “An Open Label Pilot Study of Atomoxetine Hydrochloride in Adolescents With Attention Deficit/Hyperactivity Disorder and Comorbid Cannabis Abuse.”

The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid cannabis abuse.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: October 2009

In the past adolescents with cannabis abuse have been excluded from studies in which atomoxetine for ADHD symptoms was studied. In this study the efficacy of atomoxetine on symptoms of ADHD in adolescents with ADHD and comorbid cannabis abuse will be studied.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • capsules, 1.2 mg/kg,oral,daily,12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 12 weeks Open label

Primary Measures

• The total score on the ADHD Rating Scale-IV-Parent after treatment.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To assess whether atomoxetine reduces symptoms of ADHD as measured by Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I)
  • Time Frame: 12 weeks
    Safety Issue?: No
• To assess whether atomoxetine reduces symptoms of ADHD as measured by Global Impression of Perceived Difficulties (GIPD) versus baseline.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Improvement in symptoms of depression as measured by Children's Depression Rating Scale-Revised (CDRS-R)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Improvement of symptoms of anxiety as measured by Pediatric Anxiety Rating Scale (PARS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Changes in Cannabis use and cravings as measured by a Marijuana Craving Questionnaire (MCQ)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Neurocognitive functioning as measured by a test battery (Stop-Signal Task, Timetest, Reinforcement Contingency test).
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• diagnosis ADHD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
• At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
• Cannabis Abuse or dependence based on the DSM-IV-Parent, and using a minimum of 5 joints per week

Exclusion Criteria:

• weight under 20 kg
• patients at serious suicidal risk
• patients with alcohol or drug abuse (other than cannabis)
• patients who in the investigator's judgement are likely to need psychotropic medication + psychotherapy apart from atomoxetine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Overall Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00687609

Study ID Number: 12382

ClinicalTrials.gov Identifier: NCT00687609

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Lilly Clinical Trial Registry