Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE

Verified by: Eli Lilly and Company, August 2010
First Received: May 28, 2008 | Last Updated: August 18, 2010 | Phase: Phase 4 | Start Date: September 2008
Overall Status: Terminated | Estimated Enrollment: 7
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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...

Brief Summary

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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2009

Detailed Clinical Trial Description

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
    • 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Atomoxetine
    • 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.

Outcome Measures for this Clinical Trial

Primary Measures

  • Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks
    • Time Frame: 12 weeks
      Safety Issue?: No
  • Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts
    • Time Frame: Week 4
      Safety Issue?: Yes
  • C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
    • Time Frame: Week 4
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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-TR, and using a minimum of 5 joints per week

Exclusion Criteria:

  • Weight under 20 kilograms (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: 13 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00687609