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Sponsored by: |
Clinical Innovations |
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Information provided by: | Clinical Innovations |
ClinicalTrials.gov Identifier: | NCT00892294 |
The investigators are conducting a clinical study for children and adolescents with Major Depressive Disorder.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: Duloxetine Drug: Fluoxetine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Study With Children and Adolescents With Major Depressive Disorder |
Estimated Enrollment: | 392 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Duloxetine: Experimental
Duloxetine
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Drug: Duloxetine
Duloxetine
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Fluoxetine: Experimental
Fluoxetine
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Drug: Fluoxetine
Fluoxetine
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Placebo: Experimental
Placebo
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Drug: Placebo
Placebo
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A Double-Blind, Efficacy adn Safety Study of Duloxetine versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder.
Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must be 7-17 years of age Have a diagnosis of MDD Have parental consent
Exclusion Criteria:
Contact: David Cohen | (866) 478-8391 | volunteers@citrials.com |
United States, California | |
Clinical Innovations | Recruiting |
Riverside, California, United States | |
Contact: David Cohen 866-478-8391 volunteers@citrials.com |
Responsible Party: | Clinical Innovations ( David Poling ) |
Study ID Numbers: | F1J-MC-HMCL |
Study First Received: | May 1, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892294 History of Changes |
Health Authority: | United States: Institutional Review Board |
Major Depressive Disorder, depression |
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 |