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

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ClinicalTrials.gov Identifier: NCT00083980
Recruitment Status : Terminated (European reports of liver toxicity from kava meant that the study had to stop)
First Posted : June 7, 2004
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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 or disease Intervention/treatment Phase
Anxiety Disorders Drug: Venlafaxine ER Drug: Sugar pill Drug: Kava Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : June 2002
Primary Completion Date : June 2004
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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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)

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

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 Posted: June 7, 2004    Key Record Dates
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