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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000536369

Acronym

KADSS

Enrollment

Registered

2008-10-22

Start date

2008-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

KADSS is a 3-week human clinical trial using a water soluble extract of kava to treat anxiety. We aim to determine whether this extract is safe and effective in reducing anxiety. We also are exploring the effects of kava on depression levels.

Interventions

The intervention is an aqueous extract from the peeled root of Kava (Piper methysticum). 5X 2.66g tablets (= 250mg of kavalactones per day) per day of either placebo or kava over 3-weeks. 1 week placebo washout period, followed by 2 x 1 weeks of either kava or placebo. (crossover).

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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

Outcome results