Kava Anxiety Depression Spectrum Study: A Human Clinical Trial to Treat Generalised Anxiety.

Phase 2

Completed

• Conditions: Depression; Anxiety; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12608000536369
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Chronic anxiety >2 weeks (>10 Beck Anxiety Inventory: BAI).

Exclusion Criteria

Use of synthetic antidepressants.
Psychotic/ Bipolar illness.
Significant suicidal ideation in the previous 6 months.
Diagnosed hepato-bilary disease/inflammation.
Substance abuse disorder including alcohol in the previous 6 months.
Use of benzodiazepines or opiates in the previous month.
Previous adverse reaction to kava.
Seeing a psychologist or counsellor currently or in the previous month.
Lack of facility in written or spoken English.
Currently pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Hamilton Anxiety Scale[Baseline, Weeks 1,2,3]

Secondary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)[Weeks 0(baseline),1,2,3. True baseline measurement will start from week 1 (after randomisation)];Beck Anxiety Scale (BAI)[Week 1 (randomisation after placebo washout), Week 2, Week 3]