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Cilostazol As an Adjunctive Treatment in Major Depressive Disorder: A Pilot Randomized, Double-Blind, and Placebo-Controlled Clinical Trial Publisher Pubmed



Khadivi A1 ; Shobeiri P1 ; Momtazmaneh S1 ; Samsami FS1 ; Shalbafan M2 ; Shirazi E2 ; Akhondzadeh S1
Authors
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Authors Affiliations
  1. 1. Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran
  2. 2. Mental Health Research Center, Psychosocial Health Research Institute (PHRI), Department of Psychiatry, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

Source: Psychopharmacology Published:2022


Abstract

Background: Cilostazol, a phosphodiesterase-3 inhibitor, has been reported to improve depressive-like behavior in experimental studies of depression. We investigated the safety and efficacy of cilostazol combination therapy with sertraline in treating patients with major depressive disorder (MDD) in a 6-week, parallel, randomized controlled trial. Method: Among patients referred to the outpatient clinic of a tertiary hospital, those with a diagnosis of MDD with moderate to severe severity (a score of >19 on the Hamilton depression rating scale (HAM-D)) were enrolled. A total of 54 MDD patients aged 18–65 years were randomly assigned to either the cilostazol (100 mg daily) or the placebo group. Both groups received sertraline 100 mg per day similarly. Changes in HAM-D at weeks 2, 4, and 6 were the primary outcome. Participants and outcome assessors were blinded. Results: At week 6, patients in the cilostazol group had significantly lower HAM-D score (p value= 0.015). General linear model repeated-measure analysis showed significant effect for treatment in improving MDD severity (p value <0.001). The remission rate at the study endpoint and number of responders at week 4 were significantly higher in the cilostazol group (p value= 0.047, p value= 0.032, respectively). The cilostazol group demonstrated a significantly shorter time to response. No significant difference was observed in treatment response at the study endpoint, and there were no serious adverse effects. Conclusion: Our study supports safety and efficacy of cilostazol in treating MDD patients. Trial registration: This trial was registered at the Iranian registry of clinical trials (IRCT: www.irct.ir; registration number: IRCT20090117001556N130). © 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
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