Vortioxetine vs Sertraline in Mexicans

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978286
• Other study ID #: 00228/16.
• Status: Completed
• Phase: Phase 4
• Start date: June 30, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2019
• Source: Universidad Juárez Autónoma de Tabasco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vortioxetine
10 mg per day
• Sertraline
75 mg per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Juárez Autónoma de Tabasco

References & Publications (8)

Chokka P, Bougie J, Rampakakis E, Proulx J. Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC): primary analysis from a Canadian open-label study of vortioxetine in patients with major depressive disorder (MDD). CNS Spectr. 2019 Jun;24(3):338-347. doi: 10.1017/S1092852918000913. Epub 2018 May 24. — View Citation

D'Agostino A, English CD, Rey JA. Vortioxetine (brintellix): a new serotonergic antidepressant. P T. 2015 Jan;40(1):36-40. — View Citation

Kesim M, Tiryaki A, Kadioglu M, Muci E, Kalyoncu NI, Yaris E. The effects of sertraline on blood lipids, glucose, insulin and HBA1C levels: A prospective clinical trial on depressive patients. J Res Med Sci. 2011 Dec;16(12):1525-31. — View Citation

Llorca PM, Lançon C, Brignone M, Rive B, Salah S, Ereshefsky L, Francois C. Relative efficacy and tolerability of vortioxetine versus selected antidepressants by indirect comparisons of similar clinical studies. Curr Med Res Opin. 2014 Dec;30(12):2589-606. doi: 10.1185/03007995.2014.969566. Epub 2014 Oct 10. — View Citation

Petrak F, Baumeister H, Skinner TC, Brown A, Holt RIG. Depression and diabetes: treatment and health-care delivery. Lancet Diabetes Endocrinol. 2015 Jun;3(6):472-485. doi: 10.1016/S2213-8587(15)00045-5. Epub 2015 May 17. Review. — View Citation

Petrak F, Herpertz S, Albus C, Hermanns N, Hiemke C, Hiller W, Kronfeld K, Kruse J, Kulzer B, Ruckes C, Zahn D, Müller MJ. Cognitive Behavioral Therapy Versus Sertraline in Patients With Depression and Poorly Controlled Diabetes: The Diabetes and Depression (DAD) Study: A Randomized Controlled Multicenter Trial. Diabetes Care. 2015 May;38(5):767-75. doi: 10.2337/dc14-1599. Epub 2015 Feb 17. — View Citation

Rachdi C, Damak R, Fekih Romdhane F, Ouertani H, Cheour M. Impact of sertraline on weight, waist circumference and glycemic control: A prospective clinical trial on depressive diabetic type 2 patients. Prim Care Diabetes. 2019 Feb;13(1):57-62. doi: 10.1016/j.pcd.2018.09.003. Epub 2018 Oct 2. — View Citation

Rosenblat JD, Kakar R, McIntyre RS. The Cognitive Effects of Antidepressants in Major Depressive Disorder: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Int J Neuropsychopharmacol. 2015 Jul 25;19(2). pii: pyv082. doi: 10.1093/ijnp/pyv082. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Primary	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 a 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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