SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT02219880

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial

The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.

NCT02219880 Generalized Anxiety Disorder
MeSH: Disease Anxiety Disorders

2 Interventions

Name: Kava (240mg of kavalactones per day)

Description: Kava 60 milligrams per tablet = 240mg of kavalactones per day

Type: Dietary Supplement

Kava - standardised 240mg kavalactones

Name: Placebo

Description: Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.

Type: Dietary Supplement

Placebo


Primary Outcomes

Description: Reduction of participant's anxiety will be assessed on the HAMA from baseline to week 16 across time used a mixed methods model.

Measure: Hamilton Anxiety Rating Scale (HAMA) - change in score

Time: 18 weeks

Secondary Outcomes

Description: Will assess whether response to Kava will be moderated by gamma-aminobutyric acid (GABA) transporter polymorphisms. Specifically, whether rs2601126-T allele or rs2697153-A allele carriers have greater reduction of anxiety

Measure: Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention

Time: 18 weeks

Other Outcomes

Description: Depressive symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS), self-rated anxiety on the Beck Anxiety Inventory (BAI), pathological worry on the Penn State Worry Questionnaire (PSWQ), and health-related quality of life on the Short Form Survey-12 (SF-12) will also be significantly improved by Kava over placebo; and

Measure: Changes in score to psychometric questionnaire measures

Time: 18 weeks

Description: Differential gene expression will be assessed from baseline to week 8 from participants in the Melbourne site. This will determine whether Kava increases expression of genes effecting expression of neurochemical e.g. GABA, and monoamines

Measure: Monoamine and GABA differential gene expression

Time: 8 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 rs2601126

Specifically, whether rs2601126-T allele or rs2697153-A allele carriers have greater reduction of anxiety.


2 rs2697153

Specifically, whether rs2601126-T allele or rs2697153-A allele carriers have greater reduction of anxiety.



HPO Nodes