A Randomized, Double-blind, Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression Associated With Hypobaric Hypoxia in Females
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 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 propose to determine if 8 weeks of dietary augmentation with oral 5g creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (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, combined with the examination of changes in functional connectivity based on resting-state fMRI and changes in brain metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female gender, ages 25-40 years inclusive
- •Current diagnosis of Major Depressive Disorder identified by the SCID-I
- •Current HAM-D17 score of > 16
- •Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks
- •Right-handed
- •Healthy Controls Inclusion criteria:
- •Female gender, ages 25-40 inclusive
- •No current or past DSM-5 diagnosis, as determined by clinical and structured interviews
排除标准
- •Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the SCID-I
- •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
- •Current colitis or diverticulitis
- •History of or current pulmonary disease
- •History of cardiac disease or QTc > 500ms
- •History of fibromyalgia, lupus, eosinophilia-myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
- •History of or current 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, pregnancy, failure to use adequate birth control method
- •Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome
- •Use of any excluded drugs or medications including serotonergic drugs or medications (Table 2)
- •Pre-existing eosinophilia (absolute eosinophil count > 500/uL)
- •Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia
研究组 & 干预措施
Depressed patients receiving study drug
Participants diagnosed with MDD
干预措施: 5-hydroxytryptophan and Creatine (Drug)
Depressed patients receiving placebo
Participants diagnosed with MDD
干预措施: Placebo control (Other)
结局指标
主要结局
Change From Baseline in Hamilton Depression Rating Scale
时间窗: 8 weeks
The total Hamilton Depression (HAM-D) Rating Scale provides and indication of depression In general, the higher the total score the more severe the depression. HAM-D score level of depression: 10 - 13 mild; 14-17 mild to moderate; \>17 moderate to severe. Range: 0 to 54
次要结局
未报告次要终点
研究者
Brent Michael Kious, MD, PhD
Instructor
University of Utah