Evidence map›Paper›PMID 34545997›Full record

Trial reportCNS neuroscience & therapeutics2021

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

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

Retracted 2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled TrialRetracted Publication
In one paragraph

Trial report in CNS neuroscience & therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04069819 nacompletednot on this map

Double-blind, Randomized, Placebo-Controlled Pilot Study of the Phosphodiesterase-3 Inhibitor Cilostazol as an Adjunctive to Antidepressants in Patients With Major Depressive Disorder

TypeinterventionalSponsorSadat City UniversityRan2019 to 2021Enrolled80ConditionsMajor Depressive DisorderArmsCilostazol 50 MG Oral Tablet, Escitalopram, Placebo
NCT06612593 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

The Effect of Cilostazol on the Clinical Outcome of Patients with Parkinson's Disease

TypeinterventionalSponsorAin Shams UniversityRan2024 to 2025Enrolled50ConditionsParkinson's DiseaseArmsCilostazol, Placebo, Standard treatment
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Can Adipokine FAM19A5 Be a Biomarker of Metabolic Disorders?Diabetes, metabolic syndrome and obesity : targets and therapy · 2024
    Review
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Mahmoud S AbdallahDepartment of Clinical Pharmacy, Faculty of Pharmacy, University of Sadat City, Sadat City, Egypt.ORCID 0000-0002-3237-1792
Ahmed N RamadanDepartment of Neuropsychiatry, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.
Hend Omara-RedaDepartment of Neuropsychiatry, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.
Noha O MansourClinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
Mohamed A ElsokaryDepartment of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.
Hozaifa K ElsawahDepartment of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.
Shimaa Abdelsattar ZakiDepartment of Clinical Biochemistry and Molecular Diagnostics, National Liver Institute, Menoufia University, Shebin El-Kom, Egypt.
Hend E Abo MansourDepartment of Biochemistry, Faculty of Pharmacy, Menoufia University, Shebin El-Kom, Egypt.
Esraa M MosalamDepartment of Biochemistry, Faculty of Pharmacy, Menoufia University, Shebin El-Kom, Egypt.
Menoufia University · EGAlexandria University · EGMansoura University · EGUniversity of Sadat City · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsCilostazol (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.

methods80 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.

resultsCo-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.

conclusionCLS is safe and effective short-term adjunctive therapy in patients with MDD with no other comorbid conditions. Trial registration ID:NCT04069819.

Indexed as

AdultCilostazolDouble-Blind MethodDrug Therapy, CombinationEscitalopramFemaleHumansInflammationMajor Depressive DisorderMaleMiddle AgedOutcome Assessment, Health CarePhosphodiesterase 3 InhibitorsPilot ProjectsSelective Serotonin Reuptake InhibitorsCilostazolEscitalopramPhosphodiesterase 3 InhibitorsSelective Serotonin Reuptake Inhibitorsadjunctive therapycilostazolCREB/BDNFinflammatory markersmajor depressive disorder

Identifiers

PMID34545997
PMCPMC8611782
OpenAlexW3199714321

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.