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Clinical Trials/ACTRN12616000759493
ACTRN12616000759493
Completed
Phase 2

Theanine in the Adjunctive Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial

Dr. Jerome Sarris0 sites47 target enrollmentJune 9, 2016

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr. Jerome Sarris
Enrollment
47
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Partial or non-response to antidepressants in Generalized Anxiety Disorder (GAD) is common in clinical settings, and adjunctive biological interventions may be required. Adjunctive herbal and nutraceutical treatments are a novel and promising treatment option. L-theanine is a non-protein amino acid derived most-commonly from tea (Camellia sinensis) leaves, which may be beneficial in the treatment of anxiety and sleep disturbance as suggested by preliminary evidence. We conducted a 10-week study (consisting of an 8-week double-blind placebo-controlled controlled period, and 1-week pre-study and 2-week post-study single-blinded observational periods) involving 46 participants with a DSM-5 diagnosis of GAD. Participants received adjunctive L-theanine (450-900mg) or matching placebo with their current stable antidepressant treatment, and were assessed on anxiety, sleep quality, and cognition outcomes. Results revealed that adjunctive L-theanine did not outperform placebo for anxiety reduction on the HAMA (p = 0.73) nor insomnia severity on the Insomnia Severity Index (ISI; p = 0.35). However, LT treated participants reported greater self-reported sleep satisfaction than placebo (ISI item 4; p = 0.015). Further, a separation in favour of L-theanine was noted on the ISI in those with non-clinical levels of insomnia symptoms (ISI = 14; p = 0.007). No significant cognitive effects (trail making time and the modified emotional Stroop) were revealed.

Registry
who.int
Start Date
June 9, 2016
End Date
June 14, 2018
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dr. Jerome Sarris

Eligibility Criteria

Inclusion Criteria

  • 1\.Aged between 18\-70 years
  • 2\.Meets the DSM\-IV and DSM\-5 diagnostic criteria for generalised anxiety disorder (GAD) based on structured interview (Mini International Neuropsychiatric Interview\- 6\.0 \[MINI 6\.0]. Note that while the MINI 6\.0 uses the DSM\-IV criteria, the same criteria are used in the DSM\-5\)
  • 3\.Currently taking an antidepressant for anxiety
  • 4\.Presents with anxiety (SIGH\-A score equal to or greater than 16\) at the time of study entry
  • 5\.Fluent in spoken and written English

Exclusion Criteria

  • 1\.Primary diagnosis other than GAD
  • 2\.Presentation of moderate to severe depressive symptoms (SIGMA score equal to or greater than 16\) at time of study entry
  • 3\.Presentation of suicidal ideation (score of 3 or greater on SIGMA suicidal thoughts domain) at time of study entry
  • 4\.Current diagnosis of a psychotic disorder (bipolar disorder I, schizophrenia) or Major Depressive Disorder (current episode) on structured interview (MINI 6\.0\)
  • 5\.Current substance/alcohol use disorder on structured interview (MINI 6\.0\)
  • 6\.Three or more failed trials of antidepressant pharmacotherapy for the current GAD episode. A failed trial is defined as limited improvement (equal to or less than 50% improvement) in symptoms after trialing an antidepressant for an adequate dose and duration (recommended therapeutic dose for at least 4 weeks).
  • 7\.Drinking more than 3 cups of tea (in any form e.g. black or green) per day
  • 8\.Recently commenced psychotherapy (within four weeks of study entry)
  • 9\.Known or suspected clinically unstable systemic medical disorder (e.g. cancer, organ failure) or at the discretion of the medical investigators.
  • 10\.Pregnancy or breastfeeding, or trying to conceive

Outcomes

Primary Outcomes

Not specified

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