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Clinical Trial Details

Trial ID: L3018
Source ID: NCT03978286
Associated Drug: Vortioxetine
Title: Vortioxetine vs Sertraline in Mexicans
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Depression|Type 2 Diabetes Mellitus
Interventions: DRUG: Vortioxetine|DRUG: Sertraline
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: Universidad Juárez Autónoma de Tabasco
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 21
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-06-30
Completion Date: 2018-06-30
Results First Posted:
Last Update Posted: 2019-06-13
Locations:
URL: https://clinicaltrials.gov/show/NCT03978286