The Kava & Anxiety Lowering Medication (KALM) study

Phase 3

Completed

• Conditions: Anxiety; Mood; Mental Health - Anxiety; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12610000381088
• Lead Sponsor: Integria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Any person aged 18-65 presenting with a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Structured Clinical Interview for DSM (SCID) diagnosed GAD, and a HAM-A of >14.

Exclusion Criteria

Primary diagnosis other than GAD; Psychotic or Bipolar illness; Significant suicidal ideation in the previous 6 months; antidepressant, mood stabiliser, antipsychotic, opiod analgesics, St John’s wort, Human immunodeficiency virus (HIV), anti-tumoral/cancer, blood pressure, warfarin, Parkinson’s, epileptic, migraine or anti-ulcer medication; Diagnosed hepato-biliary disease/inflammation (or elevated liver enzymes at Baseline blood test); Thyroid disease (or thyroid hormone abnormality at baseline blood test); DSM-IV diagnosed substance abuse or dependency disorder including alcohol in the previous 6 months; Regular use of Kava in the previous 12 months; Previous adverse reaction to Kava; Seeing a psychologist or counsellor currently or in the previous month; Pregnancy or trying to conceive; Lack of facility in written or spoken English; Montgomery-Asberg Depression Rating Scale (MADRS) score of >18.

Study & Design

• Study Type: Interventional
• Study Design: Not specified