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

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 Overview

• Status: Terminated
• Conditions: Attention Deficit Hyperactivity Disorder; Cannabis Abuse
• Intervention / Treatment: Drug: Atomoxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Den Haag, Netherlands, 2566 ER
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: LY139603; Strattera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks	Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher scores indicate greater impairment. The scale is scored by an investigator while interviewing the parent.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks	Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)	12 weeks
Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version	The Global Impression of Perceived Difficulties (GIPD) scale is a five-item rating of ADHD-related difficulties. For each item, difficulties during the past week are rated on a 7 point scale (1=normal, not difficult at all; 7= extremely difficult). The GIPD total score is the sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. The scale is completed by the participant.	Baseline, 12 weeks
Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)	Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.	Baseline, 12 weeks
Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)	The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.	Baseline, 12 weeks
Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)	The MCQ is a 12-item self-rated questionnaire to assess cannabis craving with 4 factors: compulsivity (an inability to control marijuana use), emotionality (use of marijuana in anticipation of relief from withdrawal/negative mood), expectancy (anticipation of positive outcomes from smoking marijuana) and purposefulness (intention and planning to use marijuana for positive outcomes). Scores are calculated on a 7-point scale (1=strongly disagree; 7=strongly agree). A separate score is calculated for each factor; scores range from 3-21 each with higher scores indicating greater craving.	Baseline, 12 weeks
Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task	Consists of 2 types of trials: go trials and stop trials. Go trials require participants to locate the position of an aircraft displayed to the left or right of a fixation point on a computer screen by pressing a left or right button. In 25% of the go stimili an additional stop stimulus (auditory signal) is presented shortly after the go stimulus. Participant then needs to inhibit their response. By varying the time period between go and stop stimulus, 50% of the trials are inhibited successfully, 50% not. The latency of inhibition is estimated. This task takes about 25 minutes.	Baseline, 12 weeks
Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task	For the Contingency Task participants estimate the duration of a time interval of 1 second by pushing a button. Responses that are within a dynamic time interval are being classified as correct. This way, 50 % of the responses are correct, 50% incorrect. Three contingency conditions: neutral, reward and response cost. The performance of this task takes about 15 minutes.	Baseline, 12 weeks
Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task	For the Time Reproduction Task participants need to reproduce the duration of a visual stimulus (lightbulb) by pressing a button. The intervals vary between 2 - 20 seconds. The performance of this task takes about 15 minutes.	Baseline, 12 weeks
C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts	Solicits suicide-related information with structured questioning. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses at a given week are listed.	Week 4
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4	Participants rate most common and most severe ideation type by frequency (1=<once per week/5=many times/day), duration (1=fleeting/5=>8 times per hour persistent, continuous), controllability (1=easily able to control thoughts/8=no attempt), deterrents to active attempts (1=deterrent definitely stopped you/8=N/A, wish to die only), and reason for ideation (1=completely for attention/revenge/reaction/5=completely to stop the pain). Only items with yes responses at a given week are listed. A participant could have a yes response in more than one item.	Week 4

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• Lilly Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: May 28, 2008
• First Submitted That Met QC Criteria: May 30, 2008
• First Posted (Estimate): June 2, 2008

Study Record Updates

• Last Update Posted (Estimate): August 24, 2010
• Last Update Submitted That Met QC Criteria: August 18, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Attention Deficit Hyperactivity Disorder with Cannabis Abuse; Marihuana Abuse; Comorbid Cannabis Abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Substance-Related Disorders; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Marijuana Abuse; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 12382 (Other Identifier: Stanford-IRB); B4Z-UT-LYEL (Other Identifier: Eli Lilly and Company)