The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

Official Summary

Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk. A retrospective longitudinal study by Rizzo et al. showed that DPP-4 inhibitors administration could have protective effects against cognitive decline in diabetic elderly. Is has been observed that GLP-1 affects brain metabolism, increases neuritic growth, and protects neuronal cells from oxidative stress and death.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE

Interventions

• DRUG: Vildagliptin 50 MG — Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk.
• DRUG: Escitalopram 20 mg — 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.

Primary Outcomes

• Effect on Hamilton Depression rating scale score (HAM-D score) (12 week)

Secondary Outcomes

• Effect on biological markers (Baseline and 12 week)
• Interleukin-6 (Baseline and 12 week)
• BDNF (Baseline and 12 week)

Trial Locations

• Faculty of Medicine, Shibīn al Kawm, Egypt

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