Status:

WITHDRAWN

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

Lead Sponsor:

Sadat City University

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

PHASE2

Brief 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 ca...

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 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

  • 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 :

May 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2024

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04410341

Start Date

May 1 2020

End Date

December 1 2024

Last Update

July 14 2025

Active Locations (1)

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1

Faculty of Medicine

Shibīn al Kawm, Egypt