NCT03978286

Vortioxetine vs Sertraline in Mexicans

Vortioxetine Versus Sertraline in Control Metabolic, Distress and Depression in Mexican Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Universidad Juárez Autónoma de Tabasco · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The assessment consisted of an extended face-to-face interview. The patients answered a structured questionnaire used to collect: sociodemographic characteristics (gender, age, education, occupation and marital status) and clinical data (pharmacotherapy, habits, consumed of drugs, diabetes complications and comorbidities). Depression was screened using Hamilton Depression Rating Scale score ≥ 14 (HAM-D), Center for epidemiologic studies depression scale revised in Spanish (CES-DR35), and Problem Areas in Diabetes Questionnaire (PAID-V); anthropometrics measurements were evaluated (weight, waist circumference and body mass index). Besides, blood samples were drawn for the following biochemical parameters: fasting plasma glucose, glycated hemoglobin (HbA1c), cholesterol and triglycerides. Patients who gave informed consent and convened inclusion criteria were attended by a psychiatrist. The pharmacological management were randomly assigned: vortioxetine (10 mg/day) or sertraline (75 mg/day) for 8 weeks, in addition, the patients maintained their established anti-diabetic treatment (oral hypoglycemic or insulin). The study ended at the 8th week, subjects were attended by psychiatrist and blood samples were drawn for evaluated biochemical parameters and the structured questionnaire previously described was applicated.The clinical measures and biochemical parameters were done baseline and after 8-week pharmacological treatment. Finally the effect of both antidepressants were compared.

Conditions

• Depression
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Vortioxetine	10 mg per day
DRUG	Sertraline	75 mg per day

Timeline

• Start date: 2016-06-30
• Primary completion: 2017-06-30
• Completion: 2018-06-30
• First posted: 2019-06-07
• Last updated: 2019-06-13