Clinical trial NCT00687609: Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE
Official title: An Open Label Pilot Study of Atomoxetine Hydrochloride in Adolescents With Attention Deficit/Hyperactivity Disorder and Comorbid Cannabis Abuse.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Cannabis Abuse
Keywords: Attention Deficit Hyperactivity Disorder with Cannabis Abuse
Marihuana Abuse
Comorbid Cannabis Abuse
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 7
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks
timeFrame: 12 weeks
measure: Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version
timeFrame: Baseline, 12 weeks
measure: Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Baseline, 12 weeks
measure: Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)
timeFrame: Baseline, 12 weeks
measure: Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task
timeFrame: Baseline, 12 weeks
measure: C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts
timeFrame: Week 4
measure: C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: