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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder; Cannabis Abuse

Intervention: Atomoxetine (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

Summary

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks

Secondary outcome:

Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks

Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version

Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)

Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)

Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)

Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task

Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task

Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task

C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts

C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4

Detailed 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.

Eligibility

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Den Haag 2566 ER, Netherlands
Additional Information

Lilly Clinical Trial Registry

Starting date: September 2008
Last updated: August 18, 2010

Page last updated: August 23, 2015

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