Back to resultsEfficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility Criteria
Inclusion Criteria: Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2 Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator) An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol. Exclusion Criteria: Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate Patients at serious suicidal risk as assessed by the investigator Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Pure ADHD
ADHD+Internalizing Disorders
ADHD+Externalizing Disorders
Arm Description
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Outcomes
Primary Outcome Measures
Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
Secondary Outcome Measures
Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.
Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.
Change From Baseline to 12 Week Endpoint in 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 Week Endpoint in 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. 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 Week Endpoint in SNAP-IV Oppositional Scale
Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00320528
Brief Title
Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pure ADHD
Arm Type
Experimental
Arm Description
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Arm Title
ADHD+Internalizing Disorders
Arm Type
Experimental
Arm Description
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Arm Title
ADHD+Externalizing Disorders
Arm Type
Experimental
Arm Description
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Other Intervention Name(s)
LY139603, Strattera
Intervention Description
0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
Primary Outcome Measure Information:
Title
Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain
Description
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
Time Frame
Baseline, 12 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
Description
Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)
Description
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Description
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline to 12 Week Endpoint in 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 Week Endpoint in 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. 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 Week Endpoint in SNAP-IV Oppositional Scale
Description
Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Description
Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Description
The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
Description
A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
Time Frame
Baseline, 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained
Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material
Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.
Exclusion Criteria:
Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder
Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
Patients at serious suicidal risk as assessed by the investigator
Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis
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
Acireale
ZIP/Postal Code
95024
Country
Italy
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
Avellino
ZIP/Postal Code
83100
Country
Italy
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
Bosisio Parini
ZIP/Postal Code
23842
Country
Italy
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
Brescia
ZIP/Postal Code
25123
Country
Italy
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
Catania
ZIP/Postal Code
95125
Country
Italy
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
Coppito
ZIP/Postal Code
67100
Country
Italy
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
Cremona
ZIP/Postal Code
26100
Country
Italy
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
Milano
ZIP/Postal Code
20129
Country
Italy
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
Ostuni
ZIP/Postal Code
72017
Country
Italy
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
Palermo
ZIP/Postal Code
90145
Country
Italy
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
Perugia
ZIP/Postal Code
06100
Country
Italy
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
Rho
ZIP/Postal Code
20017
Country
Italy
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
Rome
ZIP/Postal Code
00165
Country
Italy
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
Sassari
ZIP/Postal Code
07100
Country
Italy
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
Savigliano
ZIP/Postal Code
12038
Country
Italy
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
Siena
ZIP/Postal Code
53100
Country
Italy
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
Trieste
ZIP/Postal Code
34137
Country
Italy
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
Troina
ZIP/Postal Code
94018
Country
Italy
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
Udine
ZIP/Postal Code
33100
Country
Italy
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
Viterbo
ZIP/Postal Code
01100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
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