Kava Kava for the Treatment of Generalized Anxiety Disord... | NCT00083980

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

NCT00083980

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Terminated

Last Update Posted

Oct 19, 2012Estimated

Enrollment

16Actual

Phase

Phase 2

Conditions

Anxiety Disorders

Interventions

Venlafaxine ER
Sugar pill
Kava

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

European reports of liver toxicity from kava meant that the study had to stop

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Jun 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

Jun 4, 2004

First Submission Date that Met QC Criteria

Jun 4, 2004

First Posted Date

Jun 7, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2012

Last Update Posted Date

Oct 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
active antidepressant drug comparator	Active Comparator	Venlafaxine ER	Drug: Venlafaxine ER Drug: Sugar pill
Sugar pill	Placebo Comparator	Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine	Drug: Sugar pill
Herbal treatment kava	Experimental	Kava	Drug: Sugar pill Drug: Kava

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venlafaxine ER	Drug	75 to 225 mg daily	active antidepressant drug comparator

Measure	Description	Time Frame
Hamilton Anxiety Scale		8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of generalized anxiety disorder (GAD)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jonathan Davidson, MD	Duke University	Principal Investigator

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D000069470	Venlafaxine Hydrochloride
D000073893	Sugars

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided