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

National Institutes of Health (NIH)

Status and phase: Terminated; Phase 2

Conditions: Anxiety Disorders

Treatments: Drug: Sugar pill; Drug: Kava; Drug: Venlafaxine ER

Study type: Interventional

Funder types: NIH

Identifiers

NCT00083980

R01AT000150-01A1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of generalized anxiety disorder (GAD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

16 participants in 3 patient groups, including a placebo group

active antidepressant drug comparator

Active Comparator group

Description:

Venlafaxine ER

Treatment:

Drug: Sugar pill

Drug: Venlafaxine ER

Sugar pill

Placebo Comparator group

Description:

Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine

Treatment:

Drug: Sugar pill

Herbal treatment kava

Experimental group

Description:

Kava

Treatment:

Drug: Kava

Drug: Sugar pill