Anxiety Disorders
Conditions
Keywords
Kava, Complementary Therapies, Medicine, Herbal
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.
Interventions
DRUGVenlafaxine ER
75 to 225 mg daily
DRUGSugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
DRUGKava
140 to 280 mg per day
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of generalized anxiety disorder (GAD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale | 8 weeks |
Outcome results
None listed