Status:
COMPLETED
The Phosphodiesterase-3 Inhibitor Cilostazol as an Adjunctive to Antidepressants in Patients With Major Depressive Disorder.
Lead Sponsor:
Sadat City University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
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 thr...
Detailed Description
Cilostazol produces various powerful pleiotropic effects via restoration of intracellular second messenger cyclic adenosine monophosphate (cAMP). Treatment with cilostazol against cerebral ischemic in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04069819
Start Date
August 1 2019
End Date
December 31 2021
Last Update
October 12 2022
Active Locations (1)
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1
Faculty of Medicine
Shibīn al Kawm, Egypt