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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:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00083980
First received: June 4, 2004
Last updated: October 18, 2012
Last verified: August 2006
History of Changes

June 4, 2004
October 18, 2012
June 2002
June 2004   (final data collection date for primary outcome measure)
Hamilton Anxiety Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00083980 on ClinicalTrials.gov Archive Site
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Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)
KAVA KAVA in Generalized Anxiety: A Double-Blind Trial

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).

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety Disorders
  • 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
  • Drug: Kava
    140 to 280 mg per day
    Other Name: No brand name
  • Active Comparator: active antidepressant drug comparator
    Venlafaxine ER
    Interventions:
    • Drug: Venlafaxine ER
    • Drug: Sugar pill
  • Placebo Comparator: Sugar pill
    Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine
    Intervention: Drug: Sugar pill
  • Experimental: Herbal treatment kava
    Kava
    Interventions:
    • Drug: Sugar pill
    • Drug: Kava
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
August 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of generalized anxiety disorder (GAD)
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00083980
R01 AT000150-01A1
No
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Jonathan Davidson, MD Duke University
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP