Open AccessRETRACTED: Double‐blind, randomized, placebo‐controlled pilot study of the phosphodiesterase‐3 inhibitor cilostazol as an adjunctive to antidepressants in patients with major depressive disorder
Author(s) -
Abdallah Mahmoud S.,
Ramadan Ahmed N.,
OmaraReda Hend,
Mansour Noha O.,
Elsokary Mohamed A.,
Elsawah Hozaifa K.,
Zaki Shimaa Abdelsattar,
Abo Mansour Hend E.,
Mosalam Esraa M.
Publication year - 2021
Publication title -
cns neuroscience and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 69
eISSN - 1755-5949
pISSN - 1755-5930
DOI - 10.1111/cns.13731
Subject(s) - placebo , major depressive disorder , medicine , escitalopram , antidepressant , adjunctive treatment , randomized controlled trial , depression (economics) , aripiprazole , cls upper limits , anesthesia , pharmacology , psychiatry , schizophrenia (object oriented programming) , alternative medicine , pathology , macroeconomics , amygdala , hippocampus , optometry , economics
Abstract 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. 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. Conclusion CLS is safe and effective short‐term adjunctive therapy in patients with MDD with no other comorbid conditions. Trial registration ID:NCT04069819.