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Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)

This study has been terminated.
(European reports of liver toxicity from kava meant that the study had to stop)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00083980
First Posted: June 7, 2004
Last Update Posted: October 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)
  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: Venlafaxine ER Drug: Sugar pill Drug: Kava Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: KAVA KAVA in Generalized Anxiety: A Double-Blind Trial

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Primary Outcome Measures:
  • Hamilton Anxiety Scale [ Time Frame: 8 weeks ]

Enrollment: 16
Study Start Date: June 2002
Study Completion Date: August 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active antidepressant drug comparator
Venlafaxine ER
Drug: Venlafaxine ER
75 to 225 mg daily
Other Name: Effexor XR
Drug: Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Other Name: No brand name
Placebo Comparator: Sugar pill
Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine
Drug: Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Other Name: No brand name
Experimental: Herbal treatment kava
Kava
Drug: Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Other Name: No brand name
Drug: Kava
140 to 280 mg per day
Other Name: No brand name

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of generalized anxiety disorder (GAD)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083980


Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Jonathan Davidson, MD Duke University
  More Information

Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT00083980     History of Changes
Other Study ID Numbers: R01AT000150-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 4, 2004
First Posted: June 7, 2004
Last Update Posted: October 19, 2012
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Kava
Complementary Therapies
Medicine, Herbal

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs