The Phosphodiesterase-3 Inhibitor Cilostazol as an Adjunctive to Antidepressants in Patients With Major Depressive Disorder.

NCT04069819 | Completed DMC

• 1 other identifier: NEUR22021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Cilostazol is a PDE 3 inhibitor, which showed as decrease in HAM-D scores in post-stroke depression through inhibition of neurodegeneration in the primary lesion and secondary extrafocal sites and through promotion of neurogenesis. These beneficial effects on post-stroke depression may be involved in activation of CREB/BDNF signaling.The aim of the current study is to evaluate the potential adjunct antidepressant effect of cilostazol in adult patients with MDD. Furthermore, we will assess the relationship between HAM-D score and BDNF as well as their role as a therapeutic targets of MDD.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Effect on Hamilton Depression rating scale score (HAM-D score)

  The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.

  6 weekS

Secondary Outcomes (1)

• Effect on biological markers

  6 week

Study Arms (2)

Control group

PLACEBO COMPARATOR

Escitalopram 20 mg tablet once daily for 6 week plus placebo tablet twice daily for 6 weeks

Drug: Escitalopram; Drug: Placebo

Cilostazol group

EXPERIMENTAL

Escitalopram 20 mg tablet once daily for 6 week plus Cilostazol 50mg tablet twice daily for 6 weeks

Drug: Cilostazol 50 MG Oral Tablet; Drug: Escitalopram

Interventions

Cilostazol 50 MG Oral Tablet DRUG

Escitalopram,Selective serotonin reuptake inhibitor- Cilostazol, a selective phosphodiesterase 3 (PDE3) inhibitor, acts as an antiplatelet agent and has been widely approved for treatment of intermittent claudication with peripheral arterial disease and for secondary prevention of ischemic stroke.

Cilostazol group

Escitalopram DRUG

Escitalopram 20 mg tablet once daily for 6 week

Cilostazol group; Control group

Placebo DRUG

placebo

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 20 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
• Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

You may not qualify if:

• Patients with bipolar I or bipolar II disorder
• Patients with personality disorders
• Patients with eating disorders
• Patients with substance dependence or abuse
• Patients with concurrent active medical condition
• Patients with history of seizures
• Patients with history of receiving Electroconvulsive therapy (ECT)
• Patients with inflammatory disorders
• Patients with allergy or contraindications to the used medications
• Patients with finally pregnant or lactating females
• Cardiovascular disorders
• Severe renal impairment: creatinine clearance of ≤ 25 ml/min
• Moderate or severe hepatic impairment

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Medicine

Shibīn al Kawm, Egypt

Location

Related Publications (1)

• Abdallah MS, Ramadan AN, Omara-Reda H, Mansour NO, Elsokary MA, Elsawah HK, Zaki SA, Abo Mansour HE, Mosalam EM. Double-blind, randomized, placebo-controlled pilot study of the phosphodiesterase-3 inhibitor cilostazol as an adjunctive to antidepressants in patients with major depressive disorder. CNS Neurosci Ther. 2021 Dec;27(12):1540-1548. doi: 10.1111/cns.13731. Epub 2021 Sep 21.

  PMID: 34545997 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cilostazol; Tablets; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy, PhD.

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)