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

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Vildagliptin 50 MG

Escitalopram 20 mg

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Vildagliptin group

Arm Description

Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet once daily for 12 weeks

Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect on biological markers

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

Interleukin-6

Serum level of Interleukin-6 (IL-6)

BDNF

Serum level of Brain derived neurotrophic factor (BDNF)

Full Information

NCT ID

NCT04410341

First Posted

May 27, 2020

Last Updated

January 16, 2023

Sponsor

Sadat City University

1. Study Identification

Unique Protocol Identification Number

NCT04410341

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet once daily for 12 weeks

Arm Title

Vildagliptin group

Arm Type

Experimental

Arm Description

Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Vildagliptin 50 MG

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Escitalopram 20 mg

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

12 week

Secondary Outcome Measure Information:

Title

Effect on biological markers

Description

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

Time Frame

Baseline and 12 week

Title

Interleukin-6

Description

Serum level of Interleukin-6 (IL-6)

Time Frame

Baseline and 12 week

Title

BDNF

Description

Serum level of Brain derived neurotrophic factor (BDNF)

Time Frame

Baseline and 12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mahmoud S Abdallah

Phone

00201063340887

Mahmoud.samy@fop.usc.edu.eg

Facility Information:

Facility Name

Faculty of Medicine

City

Shibīn Al Kawm

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahmoud S Abdallah, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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