Dept. of Pharmacology All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Dept. of Psychiatry All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
J Psychiatr Res. 2024 Oct;178:298-304. doi: 10.1016/j.jpsychires.2024.08.026. Epub 2024 Aug 22.
The main hurdles with current therapies for major depressive disorder (MDD) include lack of efficacy, therapeutic latency, and adverse drug reactions. Add-on therapy to conventional antidepressants may result in better therapeutic outcomes to overcome these obstacles. Sarcosine (N-methyl glycine), an endogenous amino acid that acts by modulating the NMDA receptor, is available as a dietary supplement. So, the present study was planned to evaluate the efficacy and safety of add-on sarcosine to SSRIs in MDD. In the present randomized, double-blind clinical trial (NCT04975100), 60 eligible participants with MDD were randomly assigned to either the test group (SSRI + sarcosine) or the control group (SSRI + placebo). Clinical and biochemical parameters like MADRS, CGI, serum BDNF, and serum glycine were assessed at baseline and eight weeks. The mean reduction in MADRS score was significant in both the control (-8.7, 95% CI: -11.0 to -6.4, p < 0.001) and the test group (-13.3, 95% CI: -14.9 to -11.7, p < 0.001), but the change in the test group was significantly greater (-4.6, 95% CI: -7.5 to -1.7, p = 0.003). The test group had a significantly higher response rate (p = 0.007) and remission rate (p = 0.038) compared to the control group. There was a significant increase in serum BDNF in both groups; however, the change in the test group was significantly higher than in the control group (p = 0.041). Similarly, the test group had a significantly higher increase in serum glycine than the control group (p < 0.001). Sarcosine may be considered an efficacious and safe add-on therapy to standard SSRIs in the management of MDD. ClinicalTrial.gov IdentifierNCT04975100.
目前治疗重度抑郁症（MDD）的主要障碍包括疗效不足、治疗潜伏期和药物不良反应。在常规抗抑郁药的基础上加用辅助治疗可能会改善治疗结果，从而克服这些障碍。肌氨酸（N-甲基甘氨酸）是一种内源性氨基酸，通过调节 NMDA 受体发挥作用，可作为膳食补充剂使用。因此，本研究旨在评估 MDD 患者中添加肌氨酸辅助 SSRI 的疗效和安全性。在这项随机、双盲临床试验（NCT04975100）中，60 名符合条件的 MDD 患者被随机分为试验组（SSRI+肌氨酸）或对照组（SSRI+安慰剂）。在基线和 8 周时评估 MADRS、CGI、血清 BDNF 和血清甘氨酸等临床和生化参数。对照组（-8.7，95%CI：-11.0 至-6.4，p<0.001）和试验组（-13.3，95%CI：-14.9 至-11.7，p<0.001）的 MADRS 评分均显著降低，但试验组的变化更大（-4.6，95%CI：-7.5 至-1.7，p=0.003）。与对照组相比，试验组的应答率（p=0.007）和缓解率（p=0.038）更高。两组的血清 BDNF 均显著增加；然而，试验组的变化明显高于对照组（p=0.041）。同样，试验组的血清甘氨酸增加明显高于对照组（p<0.001）。肌氨酸可作为治疗 MDD 的标准 SSRI 的有效且安全的辅助治疗药物。ClinicalTrials.gov 标识符：NCT04975100。
