Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)
NCT ID: NCT00083980
Last Updated: 2012-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2002-06-30
2004-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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active antidepressant drug comparator
Venlafaxine ER
Venlafaxine ER
75 to 225 mg daily
Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Sugar pill
Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine
Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Herbal treatment kava
Kava
Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Kava
140 to 280 mg per day
Interventions
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Venlafaxine ER
75 to 225 mg daily
Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Kava
140 to 280 mg per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Responsible Party
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Principal Investigators
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Jonathan Davidson, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Other Identifiers
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