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NCT00083980 Clinical Trial

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

Anxiety Disorders Clinical Trial

Official title:
KAVA KAVA in Generalized Anxiety: A Double-Blind Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00083980
Other study ID # R01AT000150-01A1
Secondary ID
Status Terminated
Phase Phase 2
First received June 4, 2004
Last updated October 18, 2012
Start date June 2002
Est. completion date August 2004

Study information
Verified date August 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Terminated
Enrollment 16
Est. completion date August 2004
Est. primary completion date June 2004
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of generalized anxiety disorder (GAD)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Venlafaxine ER
75 to 225 mg daily
• Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
• Kava
140 to 280 mg per day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Outcome
Type Measure Description Time frame Safety issue
Primary Hamilton Anxiety Scale 8 weeks No
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