Clinical trial NCT03978286: Vortioxetine vs Sertraline in Mexicans
Official title: Vortioxetine Versus Sertraline in Control Metabolic, Distress and Depression in Mexican Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Type 2 Diabetes Mellitus
Keywords: depression
Type 2 diabetes Mellitus
vortioxetine
sertraline
Lead sponsor: Universidad Juárez Autónoma de Tabasco
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in remission of depression in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in severity of depression in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in treatment of diabetes related stress in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in fasting plasma glucose level in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in glycemic control in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in cholesterol control in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in triglycerides control in depressed type 2 diabetic patients.
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in weigh in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in waist circumference in depressed type 2 diabetic patients.
timeFrame: 8 weeks
measure: Effect of antidepressant treatment (sertraline versus vortioxetine) in anthropometric variables in depressed type 2 diabetic patients.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Juárez Autonoma de Tabasco
name: Isela Juarez Rojop, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petrak F, Herpertz S, Albus C, Hermanns N, Hiemke C, Hiller W, Kronfeld K, Kruse J, Kulzer B, Ruckes C, Zahn D, Muller 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.
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.
citation: D'Agostino A, English CD, Rey JA. Vortioxetine (brintellix): a new serotonergic antidepressant. P T. 2015 Jan;40(1):36-40.
citation: 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.
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.
citation: Llorca PM, Lancon 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.
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.
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):pyv082. doi: 10.1093/ijnp/pyv082.
citation: Tovilla-Zarate CA, Perez-Mandujano A, Ramirez-Gonzalez IR, Fresan A, Suarez-Mendez S, Martinez-Villasenor E, Rodriguez-Sanchez E, Villar-Soto M, Lopez-Narvaez ML, Gonzalez-Castro TB, Ble-Castillo JL, Juarez-Rojop IE. Vortioxetine versus sertraline in metabolic control, distress and depression in Mexican patients with type 2 diabetes. Ann Transl Med. 2019 Nov;7(22):656. doi: 10.21037/atm.2019.10.56.