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

• Status: Active, not recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sadat City University
• Treatments: Antidepressive Agents; Cilostazol; Citalopram; Dexetimide; Phosphodiesterase 3 Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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