Vortioxetine vs Sertraline in Mexicans

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Depression in patients with type 2 diabetes is often undiagnosed and remains untreated, leading to poor therapy adherence and ill health-related outcomes. The aim of study was evaluated the effect of vortioxetine versus sertraline in the treatment of depression, diabetes-related distress and control metabolic in subjects with type 2 diabetes and depression. was included patients who were glycosylated hemoglobin ≥ 7.5%, 18 to 60 years of age and written consent . Pharmacological treatment for depression was assigned randomly: vortioxetine (10 mg/day) or sertraline (75 mg/day) for 8 weeks. Biochemical parameters, anthropometric measures and depression symptoms were evaluated before and at the and at the 8 weeks after antidepressant treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Juárez Autónoma de Tabasco
• Treatments: Sertraline; Vortioxetine

Criteria

Inclusion Criteria:

• Individuals had to be between 18 and 85 years of age

• Clinical diagnosis of type 2 diabetes mellitus based on the American Diabetes Association criteria,

• They had to receive anti-diabetic treatment, Clinical diagnosis of major depressive episode according Association Diagnostic and Statistical Manual of Mental Disorders, five edition (DSM-V)

• Ratings scale score ≥ 14 by means of Hamilton Depression scale (HAM-D)

• Patients had to give verbal and written informed consent for this study

Exclusion Criteria:

• Neurological illness

• Psychoactive medications

• Type I diabetes

• Active suicidal ideation.