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