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

Major Depressive Disorder Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Cilostazol produces various powerful pleiotropic effects via restoration of intracellular second messenger cyclic adenosine monophosphate (cAMP). Treatment with cilostazol against cerebral ischemic injury ameliorates negative effects of cerebral hypoperfusion through the PDE3- cAMP signaling cascade with subsequent activation of inducible transcription factor cAMP response element-binding protein (CREB), suggesting the importance of the CREB signaling pathway.

Activation of CREB promotes the gene expression of neuroprotective molecules that activate subsequent anti-apoptotic pathways with the gene expression of brain-derived neurotrophic factor (BDNF). BDNF also regulates neurogenesis, proliferation, and survival of neural stem or progenitor cells, as well as neuronal survival. In addition, CREB and BDNF signaling play an important role in the pathophysiology of major depressive disorder .

Psychopharmacotherapy with antidepressants or mood stabilizers provides an effective treatment for depression after stroke, but alternative therapy by activation of CREB and BDNF signaling may exert beneficial effects on various aspects of negative mood. Drugs that activate CREB and BDNF signaling may provide a potential therapeutic approach for treatment of poststroke depression via neural cell survival and proliferation of neural progenitor cells.

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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT04069819
• Study type: Interventional
• Source: Sadat City University
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Completion date: December 31, 2021