Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders |
Drug: Venlafaxine ER Drug: Sugar pill Drug: Kava |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | KAVA KAVA in Generalized Anxiety: A Double-Blind Trial |
- Hamilton Anxiety Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | June 2002 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: active antidepressant drug comparator
Venlafaxine ER
|
Drug: Venlafaxine ER
75 to 225 mg daily
Other Name: Effexor XR
Drug: Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Other Name: No brand name
|
|
Placebo Comparator: Sugar pill
Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine
|
Drug: Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Other Name: No brand name
|
|
Experimental: Herbal treatment kava
Kava
|
Drug: Sugar pill
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
Other Name: No brand name
Drug: Kava
140 to 280 mg per day
Other Name: No brand name
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of generalized anxiety disorder (GAD)
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00083980 History of Changes |
| Other Study ID Numbers: | R01 AT000150-01A1 |
| Study First Received: | June 4, 2004 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Kava Complementary Therapies Medicine, Herbal |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Venlafaxine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013