Vortioxetine vs Sertraline in Mexicans

NCT03978286 | Completed Phase 4

• 1 other identifier: 00228/16.
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression; Type 2 Diabetes Mellitus

Keywords

depression; Type 2 diabetes Mellitus; vortioxetine; sertraline

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Effect of antidepressant treatment (sertraline versus vortioxetine) in weigh in depressed type 2 diabetic patients.

  8 weeks

• Effect of antidepressant treatment (sertraline versus vortioxetine) in waist circumference in depressed type 2 diabetic patients.

  8 weeks

• Effect of antidepressant treatment (sertraline versus vortioxetine) in anthropometric variables in depressed type 2 diabetic patients.

  8 weeks

Study Arms (2)

Vortioxetine therapy

EXPERIMENTAL

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

Sertraline therapy

EXPERIMENTAL

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

Interventions

Vortioxetine DRUG

10 mg per day

Also known as: Brintellix

Vortioxetine therapy

Sertraline DRUG

75 mg per day

Also known as: zoloft

Sertraline therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Neurological illness
• Psychoactive medications
• Type I diabetes
• Active suicidal ideation.

Sponsors & Collaborators

• Universidad Juárez Autónoma de Tabasco: lead

Related Publications (9)

• 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.

  PMID: 25690005 BACKGROUND

• 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.

  PMID: 30287230 BACKGROUND

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

  PMID: 25628505 BACKGROUND

• 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.

  PMID: 29792585 BACKGROUND

• 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.

  PMID: 22973359 BACKGROUND

• 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.

  PMID: 25249164 BACKGROUND

• 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.

  PMID: 25995125 BACKGROUND

• 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.

  PMID: 26209859 BACKGROUND

• 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.

  PMID: 31930057 DERIVED

MeSH Terms

Conditions

Depression; Diabetes Mellitus, Type 2

Interventions

Vortioxetine; Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Isela Juarez Rojop, Ph.D

  Universidad Juárez Autonoma de Tabasco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: June 7, 2019
• Study Start: June 30, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2018
• Last Updated: June 13, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: Once the article is published, information about the study will be available for a period of 3 years.
• Access Criteria: direct contact with the correspondence author