search
Back to results

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

Primary Purpose

Anxiety Disorders

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Venlafaxine ER
Sugar pill
Kava
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Kava, Complementary Therapies, Medicine, Herbal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of generalized anxiety disorder (GAD)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    Experimental

    Arm Label

    active antidepressant drug comparator

    Sugar pill

    Herbal treatment kava

    Arm Description

    Venlafaxine ER

    Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine

    Kava

    Outcomes

    Primary Outcome Measures

    Hamilton Anxiety Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2004
    Last Updated
    October 18, 2012
    Sponsor
    National Center for Complementary and Integrative Health (NCCIH)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00083980
    Brief Title
    Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)
    Official Title
    KAVA KAVA in Generalized Anxiety: A Double-Blind Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2006
    Overall Recruitment Status
    Terminated
    Why Stopped
    European reports of liver toxicity from kava meant that the study had to stop
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Center for Complementary and Integrative Health (NCCIH)

    4. Oversight

    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders
    Keywords
    Kava, Complementary Therapies, Medicine, Herbal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    active antidepressant drug comparator
    Arm Type
    Active Comparator
    Arm Description
    Venlafaxine ER
    Arm Title
    Sugar pill
    Arm Type
    Placebo Comparator
    Arm Description
    Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine
    Arm Title
    Herbal treatment kava
    Arm Type
    Experimental
    Arm Description
    Kava
    Intervention Type
    Drug
    Intervention Name(s)
    Venlafaxine ER
    Other Intervention Name(s)
    Effexor XR
    Intervention Description
    75 to 225 mg daily
    Intervention Type
    Drug
    Intervention Name(s)
    Sugar pill
    Other Intervention Name(s)
    No brand name
    Intervention Description
    Upto 3 per day for venlafainxe and 4 per day for kava placebos.
    Intervention Type
    Drug
    Intervention Name(s)
    Kava
    Other Intervention Name(s)
    No brand name
    Intervention Description
    140 to 280 mg per day
    Primary Outcome Measure Information:
    Title
    Hamilton Anxiety Scale
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of generalized anxiety disorder (GAD)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Davidson, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs