Vortioxetine vs Sertraline in Mexicans

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Vortioxetine
* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortioxetine therapy<br>patients who gave informed consent and met the inclusion criteria were attended by a psychiatrist. The pharmacological management were randomly assigned: these group of patients received vortioxetine (10 mg/day) for 8 weeks, in addition, the patients maintained their anti-diabetic treatment (oral hypoglycemic or insulin) | Drug: Vortioxetine<br>* 10 mg per day<br>* Other names: Brintellix;|
| Experimental: Sertraline therapy<br>patients who gave informed consent and met the inclusion criteria were attended by a psychiatrist. The pharmacological management were randomly assigned: these group of patients received sertraline (75 mg / day) for 8 weeks, in addition, the patients maintained their anti-diabetic treatment (oral hypoglycemic or insulin) | Drug: Sertraline<br>* 75 mg per day<br>* Other names: zoloft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of antidepressant treatment (sertraline versus vortioxetine) in remission of depression in depressed type 2 diabetic patients. | Two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The assessment of depression was performed by the Hamilton Depression Rating Scale (HAM-D) validated in the Spanish version. We used a 17-item reduced version, the range of scale was 0-50, includes the following items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. A score of 8 and above indicates depression and a high levels of anxiety symptoms. Where 14 was the cutoff point of this scale; patients with this score were diagnosed with major depression and included in the study. Depression was screened using HAM-D at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in severity of depression in depressed type 2 diabetic patients. | Two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The severity of depression was measured with the center for epidemiologic studies depression scale revised in Spanish (CES-DR35). Previous studies in a Mexican population reported a Cronbach α score of 0.9. This questionnaire consists of 35 items, the range of scale was 0-140, among them are: depressed mood, anhedonia, appetite, sleep problem, psychomotor retardation, fatigue, guilt/conscience, thinking, suicidal ideation and social. A score of 16 and above indicates clinically significant symptoms of major depression episode and the severity of depression. Depression was screened using CES-DR35 at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in treatment of diabetes related stress in depressed type 2 diabetic patients. | Two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. Diabetes related stress was screened using 5-item Problem Areas in Diabetes Scale (PAID-5). The scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress. Diabetes related stress was screened using PAID-5 at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in fasting plasma glucose level in depressed type 2 diabetic patients. | Two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The glycemic variable was measured by fasting plasma glucose level in mg/dl. at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in glycemic control in depressed type 2 diabetic patients. | Two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The glycemic variable was measured by glycosylated hemoglobin A 1c in percentage at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in cholesterol control in depressed type 2 diabetic patients. | Two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The metabolic variable was measured by cholesterol in mg/dL at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in triglycerides control in depressed type 2 diabetic patients. | Two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The metabolic variable was measured by triglycerides in mg/dL at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of antidepressant treatment (sertraline versus vortioxetine) in weigh in depressed type 2 diabetic patients. | two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The anthropometric variables were evaluated in the weight in kilograms at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in waist circumference in depressed type 2 diabetic patients. | two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The anthropometric variables were evaluated in waist circumference in centimeters at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 
| Effect of antidepressant treatment (sertraline versus vortioxetine) in anthropometric variables in depressed type 2 diabetic patients. | two groups of depressed type 2 diabetic patients were involve in the study: one group received sertraline and the second vortioxetine. The anthropometric variables were evaluated, weight and height will be combined to report BMI in kg/m^2 at the beginning of the study and at 8 weeks of treatment. Finally the effect of both antidepressant were compared. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, Type 2 diabetes Mellitus, vortioxetine, sertraline