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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by (Responsible Party): | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00700427 |
Purpose
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive under open label conditions atomoxetine up to 100 mg/day during the acute, open label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients or investigators know if patients receive atomoxetine or placebo).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: atomoxetine hydrochloride Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study |
| Estimated Enrollment: | 1925 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | October 2013 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by atomoxetine, 80-100 mg/day, QD or BID, 37 weeks
|
Drug: atomoxetine hydrochloride
Other Names:
|
|
Placebo Comparator: 2
Atomoxetine, 40-100 mg/day, QD or BID, 12 weeks followed by placebo, oral, daily, 37 weeks
|
Drug: atomoxetine hydrochloride
Other Names:
Drug: placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 56 Study Locations| 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 - 5hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00700427 History of Changes |
| Other Study ID Numbers: | 9655, B4Z-MC-LYDO |
| Study First Received: | June 16, 2008 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
ADHD Adult long term maintenance of response Attention Deficit Hyperactivity Disorder |
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders 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 |
