Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191698
First received: September 12, 2005
Last updated: October 29, 2008
Last verified: October 2008
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Purpose
The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder |
Drug: atomoxetine hydrochloride Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo [ Time Frame: over 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo [ Time Frame: over 8 weeks ] [ Designated as safety issue: No ]
- Mean change in ratings on the Oppositional subscale of the SNAP-IV [ Time Frame: over 8 weeks ] [ Designated as safety issue: No ]
- Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day. [ Time Frame: over 4 weeks ] [ Designated as safety issue: No ]
- Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S). [ Time Frame: over 8 weeks ] [ Designated as safety issue: No ]
- Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM). [ Time Frame: over 8 weeks ] [ Designated as safety issue: No ]
- Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS). [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
- Adverse events (AEs) [ Time Frame: over 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 226 |
| Study Start Date: | December 2003 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year
|
Drug: atomoxetine hydrochloride
Other Names:
|
|
Placebo Comparator: B
Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year
|
Drug: placebo |
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
- Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
- If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
- Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
- Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.
Exclusion Criteria:
- Patients who weigh less than 20 kg or greater than 60 kg at study entry.
- Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
- Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry.
- Patients with a history of any seizure disorder.
- Patients determined by the investigator to be at serious suicidal risk.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191698
Locations
| Australia, New South Wales | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Wallsend, New South Wales, Australia, 2287 | |
| Australia, Victoria | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Parkville, Victoria, Australia, 3052 | |
| Belgium | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Antwerpen, Belgium, 2020 | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Brussels, Belgium, 1200 | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Leuven, Belgium, 3000 | |
| Denmark | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Risskov, Denmark, 8240 | |
| Finland | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Helsinki, Finland, 00290 | |
| Germany | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Mannheim, Germany, 68159 | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Ulm, Germany, D-89075 | |
| Netherlands | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Nijmegen, Netherlands, 6500 HB | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Utrecht, Netherlands, 3584 CS | |
| Spain | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Tarrasa, Barcelona, Spain | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Pamplona, Navarra, Spain, 31008 | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Barcelona, Spain, 08035 | |
| United Kingdom | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Dundee, Augus, United Kingdom, DD36HH | |
| For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. | |
| Edinburgh, United Kingdom, EH9 1LL | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00191698 History of Changes |
| Other Study ID Numbers: | 7068, B4Z-MC-LYBX |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 29, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder with Hyperactivity Hyperkinesis Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Atomoxetine Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013