5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hamilton Depression Rating Scale
研究概览
简要总结
The investigators hypothesize that the administration of two widely available, naturally occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the severity of depression in individuals exposed to chronic hypoxia by living at altitude. The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI-resistant depression.
详细描述
Serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. Therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. Thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-HTP) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female gender, ages 18-64 years inclusive
- •Current diagnosis of Major Depressive Disorder identified by the SCID-5-CT
- •Current HAM-D17 score of > 15
- •Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks
排除标准
- •Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-CT
- •History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
- •Diabetes type I or II
- •Colitis or diverticulitis
- •History of pulmonary disease
- •History of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
- •Seizure disorder
- •Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
- •Current treatment with an antipsychotic, mood stabilizer, or non-SSRI antidepressant
- •Positive pregnancy test
- •Previous diagnosis of serotonin syndrome
- •Use of any excluded drugs or medications including serotonergic drugs or medications
研究组 & 干预措施
Open label treatment with 5-HTP and Creatine
干预措施: 5-hydroxytryptophan and Creatine monohydrate (Drug)
结局指标
主要结局
Change From Baseline in Hamilton Depression Rating Scale
时间窗: 8 weeks
The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression. HAM-D (outcome measure) was used to assess the level of depression at baseline and after 8 weeks of using the study drug. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.
次要结局
未报告次要终点
研究者
Perry Renshaw
MD, PhD, MBA
University of Utah