NCT04410341WithdrawnPhase 1/2
The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients
The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 14 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 27 May 2020
- Start date
- 1 May 2020
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Sadat City University
- Diseases
- Depression
- NCT number
- NCT04410341
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concurrent active medical condition
- Patients with history of receiving Electroconvulsive therapy (ECT)
Other illness
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with history of seizures
- Patients with inflammatory disorders
- Patients with allergy or contraindications to the used medications
- Cardiovascular disorders
- Moderate or severe hepatic impairment
Lab values
- Severe renal impairment: creatinine clearance of ≤ 25 ml/min
Other
- Patients with substance dependence or abuse
- Patients with finally pregnant or lactating females
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of medicine | Shibīn al Kawm | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.