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

Phase 1

Active, not recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: Vildagliptin 50 MG; Drug: Escitalopram 20 mg

• Registration Number: NCT04410341
• Lead Sponsor: Sadat City University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin group	Escitalopram 20 mg	Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks
Placebo group	Escitalopram 20 mg	Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet once daily for 12 weeks
Vildagliptin group	Vildagliptin 50 MG	Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Effect on Hamilton Depression rating scale score (HAM-D score)	12 week	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.

Secondary Outcome Measures

Name	Time	Method
Interleukin-6	Baseline and 12 week	Serum level of Interleukin-6 (IL-6)
Effect on biological markers	Baseline and 12 week	Serum level of tumor necrosis factor alpha (TNF-α)
BDNF	Baseline and 12 week	Serum level of Brain derived neurotrophic factor (BDNF)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Shibīn Al Kawm, Egypt