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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00849693 |
The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)
Condition | Intervention | Phase |
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Major Depressive Disorder |
Drug: Placebo Drug: fluoxetine Drug: duloxetine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder |
Estimated Enrollment: | 392 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator |
Drug: Placebo
Capsules identical in appearance, color, taste, and smell to study drug, PO, QD for 10 weeks
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Fluoxetine: Active Comparator |
Drug: fluoxetine
10-40mg, PO, QD, for up to 38 weeks
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Duloxetine 30-120mg: Experimental |
Drug: duloxetine
30-120mg, PO, QD (Once Daily), for up to 38 weeks
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Duloxetine 30mg: Experimental |
Drug: duloxetine
30mg, PO, QD (Once Daily), for up to 10 weeks
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Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1877-285-4559) or | 1-317-615-4559 |
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 |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 7109, F1J-MC-HMCL |
Study First Received: | February 23, 2009 |
Last Updated: | August 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00849693 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Depression Adrenergic Agents Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Duloxetine |
Serotonin Behavioral Symptoms Fluoxetine Dopamine Mental Disorders Mood Disorders Dopamine Agents Antidepressive Agents, Second-Generation Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Duloxetine Pathologic Processes Mental Disorders Therapeutic Uses |
Antidepressive Agents, Second-Generation Antidepressive Agents Disease Depression Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Fluoxetine Serotonin Agents Mood Disorders Dopamine Agents Central Nervous System Agents |