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
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Kava, Complementary Therapies, Medicine, Herbal
Eligibility Criteria
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
NCT ID
NCT00083980
First Posted
June 4, 2004
Last Updated
October 18, 2012
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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)
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