Vortioxetine vs Sertraline in Mexicans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes

NCT03580967

Type2 Diabetes Major Depressive Disorder

WITHDRAWN PHASE4

Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression

NCT03766867

Major Depressive Disorder

COMPLETED PHASE2

Real-life Effectiveness of Vortioxetine in Depression

NCT03555136

Major Depressive Disorder

COMPLETED

Tolerability, Safety and Efficacy of Vortioxetine

NCT04301492

Depression

UNKNOWN PHASE4

Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment

NCT03779789

Major Depressive Disorder

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vortioxetine therapy

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)

Group Type EXPERIMENTAL

Vortioxetine

Intervention Type DRUG

10 mg per day

Sertraline therapy

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)

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

75 mg per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vortioxetine

10 mg per day

Intervention Type DRUG

Sertraline

75 mg per day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Brintellix zoloft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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