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

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ClinicalTrials.gov Identifier: NCT00687609
Recruitment Status : Terminated (The study was discontinued early, owing to difficulties in recruiting the target sample after seven patients had been recruited.)
First Posted : June 2, 2008
Results First Posted : August 19, 2010
Last Update Posted : August 24, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Attention Deficit Hyperactivity Disorder
Cannabis Abuse
Intervention Drug: Atomoxetine
Enrollment 7
Recruitment Details The study was discontinued early owing to difficulties in recruiting the target sample after seven patients had been recruited. Therefore, only disposition, demographic, and safety data are reported.
Pre-assignment Details  
Arm/Group Title Atomoxetine
Hide Arm/Group Description 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Period Title: Overall Study
Started 7
Completed 4
Not Completed 3
Reason Not Completed
Physician Decision             1
Withdrawal by Subject             2
Arm/Group Title Atomoxetine
Hide Arm/Group Description 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
16.3  (0.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
1
  14.3%
Male
6
  85.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants
Caucasian 5
East Asian 1
West Asian 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 7 participants
7
Columbia Suicide Rating Scale (C-SSRS) Suicidal Behavior   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants
Aborted Attempt 1
Non-Suicidal Self Injurious Behavior 2
Presence of Suicidal Behavior 1
Actual Attempt 1
[1]
Measure Description: Solicits suicide-related information with structured questioning. Scale consists of 28 items in 4 sections: suicidal behavior, actual attempts, suicidal ideation, intensity of ideation. Suicidal behavior consists of 7 yes/no items: actual attempt, non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts or behavior, presence of suicidal behavior, completed suicide. Only items with yes responses are listed.
1.Primary Outcome
Title Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
1
11.Secondary Outcome
Title C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Frequency (Most Common) Once a Week 1
Frequency (Most Severe) Once a Week 1
Duration (Most Common) Fleeting 1
Duration (Most Severe) Fleeting 1
Control (Most Common) Little Diffficulty 1
Control (Most Severe) Little Diffficulty 1
Deterrent (Most Common) Uncertain It Stopped You 1
Deterrent (Most Severe) Uncertain it Stopped You 1
Reasons (Most Common) Mostly to Get Attention 1
Reasons (Most Severe) Mostly to Get Attention 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine
Hide Arm/Group Description 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
All-Cause Mortality
Atomoxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atomoxetine
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Gastrointestinal disorders   
Dry mouth  1  1/7 (14.29%)  1
Nausea  1  5/7 (71.43%)  8
Vomiting  1  1/7 (14.29%)  1
General disorders   
Asthenia  1  1/7 (14.29%)  1
Irritability  1  2/7 (28.57%)  2
Malaise  1  1/7 (14.29%)  1
Infections and infestations   
Influenza  1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/7 (14.29%)  1
Nervous system disorders   
Disturbance in attention  1  1/7 (14.29%)  1
Dizziness  1  1/7 (14.29%)  1
Headache  1  2/7 (28.57%)  2
Psychiatric disorders   
Decreased activity  1  1/7 (14.29%)  1
Depression  1  1/7 (14.29%)  1
Stress  1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/7 (14.29%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
The study was discontinued early, owing to difficulties in recruiting the target sample after seven patients had been recruited. Therefore, only disposition, demographic, and safety data are reported.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00687609     History of Changes
Other Study ID Numbers: 12382
B4Z-UT-LYEL ( Other Identifier: Eli Lilly and Company )
First Submitted: May 28, 2008
First Posted: June 2, 2008
Results First Submitted: July 22, 2010
Results First Posted: August 19, 2010
Last Update Posted: August 24, 2010