Trial Outcomes & Findings for Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE (NCT NCT00687609)
NCT ID: NCT00687609
Last Updated: 2010-08-24
Results Overview
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.
TERMINATED
PHASE4
7 participants
12 weeks
2010-08-24
Participant Flow
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.
Participant milestones
| Measure |
Atomoxetine
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Atomoxetine
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=7 Participants
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
|
|---|---|
|
Age Continuous
|
16.3 Years
STANDARD_DEVIATION 0.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
7 participants
n=5 Participants
|
|
Columbia Suicide Rating Scale (C-SSRS) Suicidal Behavior
Aborted Attempt
|
1 Participants
n=5 Participants
|
|
Columbia Suicide Rating Scale (C-SSRS) Suicidal Behavior
Non-Suicidal Self Injurious Behavior
|
2 Participants
n=5 Participants
|
|
Columbia Suicide Rating Scale (C-SSRS) Suicidal Behavior
Presence of Suicidal Behavior
|
1 Participants
n=5 Participants
|
|
Columbia Suicide Rating Scale (C-SSRS) Suicidal Behavior
Actual Attempt
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Atomoxetine
n=7 Participants
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
|
|---|---|
|
C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Atomoxetine
n=7 Participants
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
|
|---|---|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Frequency (Most Common) Once a Week
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Frequency (Most Severe) Once a Week
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Duration (Most Common) Fleeting
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Duration (Most Severe) Fleeting
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Control (Most Common) Little Diffficulty
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Control (Most Severe) Little Diffficulty
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Deterrent (Most Common) Uncertain It Stopped You
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Deterrent (Most Severe) Uncertain it Stopped You
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Reasons (Most Common) Mostly to Get Attention
|
1 Participants
|
|
C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4
Reasons (Most Severe) Mostly to Get Attention
|
1 Participants
|
Adverse Events
Atomoxetine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=7 participants at risk
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Asthenia
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Irritability
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Malaise
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2
|
|
Psychiatric disorders
Decreased activity
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Stress
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
1/7 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60