A Randomized Double-Blind Placebo-Controlled Pilot Study of L-tyrosine and L-tryptophan in Depressed Patients Receiving L-methylfolate and and SSRI
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Benefit of nutritional supplement
研究概览
简要总结
**This study never received IRB approval and no participants were ever enrolled** The purpose of this study is to determine if adding over the counter nutritional supplements will have a benefit to participants currently taking prescribed antidepressants who have not experienced complete remission of their depression symptoms.
详细描述
Inclusion Criteria:
Detroit VA Patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms as defined by "feeling their normal selves"
Randomized into two groups:
Experimental: will receive month supply of deplin 15mg, L-tyrosine 6g/d into 2 divided doses, and L-tryptophan 2g/d into 2 divided doses.
Control: will receive month supply of deplin 15mg , and 2 placebo pills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans Administration Medical Center patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms.
排除标准
- 未提供
研究组 & 干预措施
Deplin w Supplements
deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days
干预措施: L-tyrosine (Dietary Supplement)
Deplin w Supplements
deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days
干预措施: L-Tryptophan (Dietary Supplement)
Deplin w Supplements
deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days
干预措施: deplin (Drug)
Deplin w placebo
deplin 15mg daily plus Placebo A and Placebo B for 30 days
干预措施: deplin (Drug)
Deplin w placebo
deplin 15mg daily plus Placebo A and Placebo B for 30 days
干预措施: Placebo A (Other)
Deplin w placebo
deplin 15mg daily plus Placebo A and Placebo B for 30 days
干预措施: Placebo B (Other)
结局指标
主要结局
Benefit of nutritional supplement
时间窗: 30 days
Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.
次要结局
未报告次要终点