Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial (KGAD)
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|ClinicalTrials.gov Identifier: NCT02219880|
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Dietary Supplement: Kava (240mg of kavalactones per day) Dietary Supplement: Placebo||Phase 4|
The primary aim is to confirm the efficacy and safety of Kava compared to placebo in Generalized Anxiety Disorder (GAD). Secondary aims of the study are to confirm the relationship between specific genetic variations and response to Kava, and to explore the effects of Kava on the expression of specific genes.
Consenting participants will be randomly allocated to take either Kava or placebo over 18 weeks. They will be assessed at regular interviews throughout the trial and will have four blood tests (liver function tests to monitor participant safety, and collection of genetic material providing information on neurochemistry). The design of the study is a multi-centre, 18-week, 2-arm, double-blind randomised clinical trial (RCT) using a standardised pharmaceutical-grade water-soluble extract of Kava (240mg of kavalactones per day) versus placebo in 210 adults with GAD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial|
|Actual Study Start Date :||October 13, 2015|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||May 31, 2018|
Placebo Comparator: Placebo
Inert tablets matched for colour, size and consistency to active arm treatment. Both treatment arm tablets will match in appearance, and neither participants nor the trial clinicians will know what they are taking.
Dietary Supplement: Placebo
Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
Experimental: Kava - standardised 240mg kavalactones
Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day
Dietary Supplement: Kava (240mg of kavalactones per day)
Kava 60 milligrams per tablet = 240mg of kavalactones per day
- Hamilton Anxiety Rating Scale (HAMA) - change in score [ Time Frame: 18 weeks ]Reduction of participant's anxiety will be assessed on the HAMA from baseline to week 16 across time used a mixed methods model.
- Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention [ Time Frame: 18 weeks ]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
- Changes in score to psychometric questionnaire measures [ Time Frame: 18 weeks ]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
- Monoamine and GABA differential gene expression [ Time Frame: 8 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219880
|Royal Brisbane & Women's Hospital|
|Brisbane, Queensland, Australia, 4006|
|Centre for Human Psychopharmacology - Swinburne University|
|Melbourne, Victoria, Australia, 3122|
|Principal Investigator:||Jerome Sarris, PhD||The University of Melbourne and The Melbourne Clinic|