NCT00083980

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

KAVA KAVA in Generalized Anxiety: A Double-Blind Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
DRUG	Venlafaxine ER	75 to 225 mg daily
DRUG	Sugar pill	Upto 3 per day for venlafainxe and 4 per day for kava placebos.
DRUG	Kava	140 to 280 mg per day

Timeline

• Start date: 2002-06-01
• Primary completion: 2004-06-01
• Completion: 2004-08-01
• First posted: 2004-06-07
• Last updated: 2012-10-19