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Sponsors and Collaborators: |
Takeda Global Research & Development Center, Inc. H. Lundbeck A/S |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00730691 |
The purpose of this study is to determine the safety and efficacy of Lu AA21004 in adults with generalized anxiety disorder.
Condition | Intervention | Phase |
---|---|---|
Generalized Anxiety Disorder |
Drug: Lu AA21004 Drug: Duloxetine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder |
Estimated Enrollment: | 750 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Lu AA21004
Lu AA21004 2.5 mg tablet, orally, once daily for up to 8 weeks.
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2: Experimental |
Drug: Lu AA21004
Lu AA21004 5 mg tablet, orally, once daily for up to 8 weeks.
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3: Experimental |
Drug: Lu AA21004
Lu AA21004 10 mg tablet, orally, once daily for up to 8 weeks.
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4: Placebo Comparator |
Drug: Lu AA21004
Lu AA21004 placebo-matching tablet, orally, once daily for up to 8 weeks.
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5: Active Comparator |
Drug: Duloxetine
Duloxetine 60 mg tablet, orally, once daily for up to 8 weeks.
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Subjects participating in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg of Lu AA21004 once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks.
Subjects will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Subjects who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Has 1 or more of the following:
Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | LuAA21004_308 |
Study First Received: | August 6, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00730691 |
Health Authority: | United States: Food and Drug Administration |
Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy |
Dopamine Anxiety Disorders Mental Disorders |
Mood Disorders Serotonin Duloxetine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs |
Serotonin Uptake Inhibitors Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |