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

Sponsor
National Center for Complementary and Integrative Health (NCCIH) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00083980
Collaborator
(none)
16
Enrollment
3
Arms
26
Duration (Months)

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Jun 1, 2002
Actual Primary Completion Date :
Jun 1, 2004
Actual Study Completion Date :
Aug 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: active antidepressant drug comparator

Venlafaxine ER

Drug: Venlafaxine ER
75 to 225 mg daily
Other Names:
  • Effexor XR

    • Drug: Sugar pill
    Upto 3 per day for venlafainxe and 4 per day for kava placebos.
    Other Names:
  • 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 Names:
  • 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 Names:
  • No brand name

    • Drug: Kava
    140 to 280 mg per day
    Other Names:
  • No brand name

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hamilton Anxiety Scale [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of generalized anxiety disorder (GAD)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: Jonathan Davidson, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Center for Complementary and Integrative Health (NCCIH)
    ClinicalTrials.gov Identifier:
    NCT00083980
    Other Study ID Numbers:
    • R01AT000150-01A1
    First Posted:
    Jun 7, 2004
    Last Update Posted:
    Oct 19, 2012
    Last Verified:
    Aug 1, 2006
    Keywords provided by National Center for Complementary and Integrative Health (NCCIH)
    Kava
    Complementary Therapies
    Medicine, Herbal
    Additional relevant MeSH terms:
    Anxiety Disorders
    Venlafaxine Hydrochloride

    Study Results

    No Results Posted as of Oct 19, 2012