NCT04274114终止2 期
Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial
Hospital Universitario Dr. Jose E. Gonzalez1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年1月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Response on Clinical Global Impression-Improvement
研究概览
简要总结
The objective of this randomized clinical trial is to examine the efficacy of L-glutamine for the treatment of generalized anxiety disorder compared versus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with generalized anxiety disorder defined by the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- •Generalized anxiety disorder is the primary psychiatric disorder.
- •Untreated patients or; patients treated with paroxetine, sertraline, citalopram, escitalopram, venlafaxine or duloxetine at least for 6 weeks on a stable dose; or patients treated with any benzodiazepine at least for 4 weeks on a stable dose.
- •Hamilton Anxiety Rating Scale score major or equal to 20 and a score major or equal to 2 on items 1 and 2 of the same scale at both screening and baseline.
- •Clinical Global Impression-Severity major or equal to 4 at both screening and baseline.
排除标准
- •Unable to give informed consent.
- •Currently participating in another clinical research.
- •Any other psychiatric disorder not included in the Anxiety Disorders section of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). Secondary diagnosis of other anxiety disorders are allowed provided the diagnosis is not more prominent than generalized anxiety disorder symptoms.
- •Suicide risk as assessed by the researcher at screening or baseline.
- •History of substance abuse in the previous six months before the screening visit.
- •Suffering a medically relevant or instable disease.
- •If woman, being pregnant at screening visit.
- •If woman, being breastfeeding.
- •A score major or equal to 20 on the Montgomery-Asberg Depression Rating Scale at screening or baseline.
- •As judged by a researcher, the patient might not adhere to the intervention or complete follow-up.
- •History of use of a banned drug in the past two weeks prior the baseline visit; three weeks in the case of monoamine oxidase inhibitors; one week in the case of fluvoxamine or a tricyclic antidepressant; two weeks for any antipsychotic and; six weeks por long-acting injectable antipsychotics.
- •History of use of L-glutamine the most part of the days of the previous month before the baseline visit.
- •History of psychotherapy treatment in the past month before the baseline visit.
研究组 & 干预措施
Experimental group
Experimental
Patients in this group will receive flexible doses of L-glutamine ranging from 5 to 25 grams once daily for 8 weeks. L-glutamine is administered as a powder dissolved in water.
干预措施: L Glutamine (Drug)
Placebo group
Placebo Comparator
Patients in this group will receive flexible doses of placebo ranging from 5 to 25 grams once daily for 8 weeks. Placebo is administered as a powder dissolved in water.
干预措施: Placebos (Drug)
结局指标
主要结局
Response on Clinical Global Impression-Improvement
时间窗: Change from baseline to week 8
Score of 1 or 2
次要结局
- Reduction of Hamilton Anxiety Rating Scale score(Change from baseline to week 8)
- Response on Hamilton Anxiety Rating Scale(Change from baseline to week 8)
研究者
José Alfonso Ontiveros Sánchez De la Barquera
Associate Professor
Hospital Universitario Dr. Jose E. Gonzalez
研究点 (1)
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