Double-blind, randomized, placebo-controlled pilot study of the phosphodiesterase-3 inhibitor cilostazol as an adjunctive to antidepressants in patients with major depressive disorder

一项双盲、随机、安慰剂对照的试点研究,探讨磷酸二酯酶 3 抑制剂西洛他唑作为重度抑郁症患者抗抑郁药的辅助治疗效果

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作者:Mahmoud S Abdallah, Ahmed N Ramadan, Hend Omara-Reda, Noha O Mansour, Mohamed A Elsokary, Hozaifa K Elsawah, Shimaa Abdelsattar Zaki, Hend E Abo Mansour, Esraa M Mosalam

Aims

Cilostazol (CLS) has shown antidepressant effect in cardiovascular patients, post-stroke depression, and animal models through its neurotrophic and antiinflammatory activities. Consequently, we aimed to investigate its safety and efficacy in patients with MDD by conducting double-blind, randomized, placebo-controlled pilot study.

Conclusion

CLS is safe and effective short-term adjunctive therapy in patients with MDD with no other comorbid conditions.

Methods

80 participants with MDD (DSM-IV criteria) and Hamilton Depression Rating Scale (HDRS) score >20 were treated with CLS 50 mg or placebo twice daily plus escitalopram (ESC) 20 mg once daily for six weeks. Patients were evaluated by HDRS scores (weeks 0, 2, 4, and 6). Serum levels of CREB1, BDNF, 5-HT, TNF-α, NF- κB, and FAM19A5 were assessed pre- and post-treatment.

Results

Co-administration of CLS had markedly decreased HDRS score at all-time points compared to the placebo group (p < 0.001). Early improvement, response, and remission rates after 6 weeks were significantly higher in the CLS group (90%, 90%, 80%, respectively) than in the placebo group (25%, 65%, 50% respectively) (p < 0.001). Moreover, the CLS group was superior to the placebo group in modulation of the measured neurotrophic and inflammatory biomarkers.

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