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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00083980 |
The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD).
Condition | Intervention | Phase |
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Anxiety Disorders |
Drug: Kava kava Drug: Venlafaxine-XR |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | KAVA KAVA in Generalized Anxiety: A Double-Blind Trial |
Estimated Enrollment: | 124 |
Kava kava (KAV) is a plant-derived treatment widely used in Europe to treat anxiety disorders. Several studies suggest that KAV may be effective in reducing anxiety symptoms; however, trial data are limited. This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of GAD.
This study will last 10 weeks. Participants will be randomly assigned to receive KAV, VEN, or placebo for 8 weeks. Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation. Self-report scales and questionnaires will be used to assess the anxiety, depression, and functional impairment of participants. Side effects, vital signs, and laboratory measures will be monitored throughout the study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study ID Numbers: | R01 AT000150-01A1 |
Study First Received: | June 4, 2004 |
Last Updated: | August 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00083980 History of Changes |
Health Authority: | United States: Federal Government |
Kava Complementary Therapies Medicine, Herbal |
Kava Neurotransmitter Agents Anxiety Disorders Mental Disorders Venlafaxine |
Psychotropic Drugs Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Antidepressive Agents Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Pathologic Processes |
Serotonin Agents Anxiety Disorders Mental Disorders Therapeutic Uses Venlafaxine Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |