Anxiety Disorders Clinical Trial
Official title:
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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