The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients

Sadat City University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Major Depressive Disorder

Interventions

Vildagliptin 50 MGDRUG

Escitalopram 20 mgDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 18 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

Locations (1)

Faculty of Medicine

Shibīn al Kawm, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 12 week

Secondary Outcomes

Effect on biological markers

Serum level of tumor necrosis factor alpha (TNF-α)

Time frame: Baseline and 12 week

Interleukin-6

Serum level of Interleukin-6 (IL-6)

Time frame: Baseline and 12 week

BDNF

Serum level of Brain derived neurotrophic factor (BDNF)

Time frame: Baseline and 12 week

Data from ClinicalTrials.gov

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