NCT00083980

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2002

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

October 19, 2012

Status Verified

August 1, 2006

Enrollment Period

2 years

First QC Date

June 4, 2004

Last Update Submit

October 18, 2012

Conditions

Anxiety Disorders

Keywords

KavaComplementary TherapiesMedicine, Herbal

Outcome Measures

Primary Outcomes (1)

  • Hamilton Anxiety Scale

    8 weeks

Study Arms (3)

active antidepressant drug comparator

ACTIVE COMPARATOR

Venlafaxine ER

Drug: Venlafaxine ERDrug: 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 pillDrug: Kava

Interventions

Venlafaxine ERDRUG

75 to 225 mg daily

Also known as: Effexor XR
active antidepressant drug comparator
Sugar pillDRUG

Upto 3 per day for venlafainxe and 4 per day for kava placebos.

Also known as: No brand name
Herbal treatment kavaSugar pillactive antidepressant drug comparator
KavaDRUG

140 to 280 mg per day

Also known as: No brand name
Herbal treatment kava

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of generalized anxiety disorder (GAD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Venlafaxine HydrochlorideSugars

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipidsCarbohydrates

Study Officials

  • Jonathan Davidson, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2004

First Posted

June 7, 2004

Study Start

June 1, 2002

Primary Completion

June 1, 2004

Study Completion

August 1, 2004

Last Updated

October 19, 2012

Record last verified: 2006-08