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临床试验/ACTRN12616000759493
ACTRN12616000759493已完成2 期

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

Dr. Jerome Sarris0 个研究点目标入组 47 人开始时间: 2016年6月9日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
47

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 70 Years(—)
性别
All

入选标准

  • 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

排除标准

  • 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
  • 11.Not using a medically approved form of contraception (including abstinence) if female and of childbearing age
  • 12.Unable to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol

研究者

发起方
Dr. Jerome Sarris

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