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

October 18, 2012 updated by: National Center for Complementary and Integrative Health (NCCIH)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of generalized anxiety disorder (GAD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Anxiety Scale
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jonathan Davidson, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

June 4, 2004

First Submitted That Met QC Criteria

June 4, 2004

First Posted (Estimate)

June 7, 2004

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT000150-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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