Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD) - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00083980

Purpose

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
Anxiety Disorders	Drug: Kava kava Drug: Venlafaxine-XR	Phase II

MedlinePlus related topics: Anxiety

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:

124

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of generalized anxiety disorder (GAD)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083980

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Jonathan Davidson, MD

Duke University

More Information

Study ID Numbers:	R01 AT000150-01A1
Study First Received:	June 4, 2004
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00083980
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Kava
Complementary Therapies
Medicine, Herbal

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Venlafaxine
Serotonin

Additional relevant MeSH terms:

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
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009