Back to resultsPilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE (PEACE)
Primary Purpose
Attention Deficit Hyperactivity Disorder, Cannabis Abuse
Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder with Cannabis Abuse, Marihuana Abuse, Comorbid Cannabis Abuse
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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atomoxetine
Arm Description
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00687609
Brief Title
Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE
Acronym
PEACE
Official Title
An Open Label Pilot Study of Atomoxetine Hydrochloride in Adolescents With Attention Deficit/Hyperactivity Disorder and Comorbid Cannabis Abuse.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued early, owing to difficulties in recruiting the target sample after seven patients had been recruited.
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Cannabis Abuse
Keywords
Attention Deficit Hyperactivity Disorder with Cannabis Abuse, Marihuana Abuse, Comorbid Cannabis Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
LY139603, Strattera
Intervention Description
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Primary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks
Description
Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)
Time Frame
12 weeks
Title
Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task
Description
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.
Time Frame
Baseline, 12 weeks
Title
C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts
Description
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.
Time Frame
Week 4
Title
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Description
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.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Den Haag
ZIP/Postal Code
2566 ER
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE
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