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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

Tracking Information
First Submitted Date  ICMJE May 28, 2008
First Posted Date  ICMJE June 2, 2008
Results First Submitted Date  ICMJE July 22, 2010
Results First Posted Date  ICMJE August 19, 2010
Last Update Posted Date August 24, 2010
Study Start Date  ICMJE September 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
The total score on the ADHD Rating Scale-IV-Parent after treatment. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00687609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks [ Time Frame: 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 [ Time Frame: Baseline, 12 weeks ]
    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) [ Time Frame: Baseline, 12 weeks ]
    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) [ Time Frame: Baseline, 12 weeks ]
    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) [ Time Frame: Baseline, 12 weeks ]
    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 [ Time Frame: Baseline, 12 weeks ]
    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 [ Time Frame: Baseline, 12 weeks ]
    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 [ Time Frame: Baseline, 12 weeks ]
    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 [ Time Frame: Week 4 ]
    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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • To assess whether atomoxetine reduces symptoms of ADHD as measured by Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) [ Time Frame: 12 weeks ]
  • To assess whether atomoxetine reduces symptoms of ADHD as measured by Global Impression of Perceived Difficulties (GIPD) versus baseline. [ Time Frame: 12 weeks ]
  • Improvement in symptoms of depression as measured by Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: 12 weeks ]
  • Improvement of symptoms of anxiety as measured by Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 12 weeks ]
  • Changes in Cannabis use and cravings as measured by a Marijuana Craving Questionnaire (MCQ) [ Time Frame: 12 weeks ]
  • Neurocognitive functioning as measured by a test battery (Stop-Signal Task, Timetest, Reinforcement Contingency test). [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE
Official Title  ICMJE An Open Label Pilot Study of Atomoxetine Hydrochloride in Adolescents With Attention Deficit/Hyperactivity Disorder and Comorbid Cannabis Abuse.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorder
  • Cannabis Abuse
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Atomoxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 8, 2010)
7
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2008)
30
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00687609
Other Study ID Numbers  ICMJE 12382
B4Z-UT-LYEL ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP