Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)
- Conditions
- Anxiety Disorders
- Interventions
- Registration Number
- NCT00083980
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- Diagnosis of generalized anxiety disorder (GAD)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Herbal treatment kava Sugar pill Kava Sugar pill Sugar pill Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine active antidepressant drug comparator Sugar pill Venlafaxine ER active antidepressant drug comparator Venlafaxine ER Venlafaxine ER Herbal treatment kava Kava Kava
- Primary Outcome Measures
Name Time Method Hamilton Anxiety Scale 8 weeks
- Secondary Outcome Measures
Name Time Method