Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes

NCT03580967 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 210161
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll participants who have been diagnosed with type 2 diabetes and are experiencing symptoms of depression. This study will look at an anti-depressant medication called vortioxetine (Trintellix). Vortioxetine is an oral medication (pill) that has been approved by the US Food and Drug Administration (FDA) to treat depression in adults. The purpose of this study is to look at what effects (if any) vortioxetine may have on symptoms of depression in patients with type 2 diabetes. This study will also look at what effects (if any) vortioxetine has on blood sugar, and how vortioxetine may improve the way our brains are able to adapt and respond to stress.

Conditions

Type2 Diabetes; Major Depressive Disorder

Keywords

Type 2 Diabetes; Major Depressive Disorder; Vortioxetine

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D)

  The HAM-D is an 18-item questionnaire used to provide an indication of depression. The patient is rated by a clinician on 18 items scored on a 3-point or 5-point Likert-type scale. Remission of Major Depressive Disorder symptoms is defined as a total score on the HAM-D of ≤ 7.

  Baseline and End of Treatment visit (Week 8)

Study Arms (1)

Drug: Vortioxetine

OTHER

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

Oral pill to be taken daily for 8 weeks, 10 or 20 mg dosage. Participants who cannot tolerate this dose may be reduced to 5mg dose.

Also known as: Trintellix

Drug: Vortioxetine

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 40 to 65 years of age at time of screening visit.
• Women only: Must be post-menopausal at time of screening visit (i.e., defined by NO menstruation for at least the past 12-months).
• Diagnosis of T2D, as defined by a diagnosis of T2D (for at least 12 months) in the medical record made by a physician (i.e., denoted as 250.XX according to ICD-9/ICD-10 billing codes) OR
• current use of oral hypoglycemic medications or insulin OR
• having a fasting plasma glucose ≥126 mg/dL in the medical record OR
• having a 2-hour oral glucose tolerance test ≥200 mg/dL in the medical record
• Patients who meet criteria for current MDD without significant co-morbid psychiatric diagnoses, as determined by study PI from screening visit:
• Clinical Psychiatric Interview to determine DSM-V criteria for current MDD AND
• A minimum score of 18 on the Hamilton Depression Scale (HAM-D)
• Patients with T2D and current MDD that would benefit from antidepressant therapy, which may include:
• Patients with current MDD who were NOT prescribed an antidepressant medication in the past;
• Patients with current MDD who are NOT responding to their current prescribed antidepressant;
• Patients with current MDD who are experiencing breakthrough depressive symptoms despite being maintained on another antidepressant.
• Must have the ability to provide informed consent to participate in the study.

You may not qualify if:

• Patients with any form of contraindication to Vortioxetine treatment, as outlined in the medication packet insert, (e.g., presence of a known hypersensitivity to the study drug or hypersensitivity to MAO-I use, etc.).
• Participants weighing \>550 lbs (per MRI weight restrictions set by Loyola University Medical Center);
• Patients with a pacemaker, AICD, ossicular prosthesis, nerve stimulator, or another contraindication to MRI;
• Pregnant patients;
• Patients with an inability to tolerate being in enclosed places/spaces such as MRI;
• Patients with a history of neurosurgery, brain irradiation, or cerebral endovascular treatment.;
• Patients with history of epilepsy, stroke, neurodegenerative disorder, severe traumatic brain injury, hydrocephalus or demyelinating disorder;
• Patients with a history of malignant neoplasm
• Specific pre-existing chronic pain conditions such as rheumatoid arthritis or fibromyalgia. However, this will NOT include more localized pain-related conditions such as low-back pain or complications associated with T2D (e.g., diabetic neuropathy).
• History of peptic ulcer complicated by perforation, hemorrhage, or obstruction; symptoms of peptic ulcer within 4 weeks of enrollment date that has not been treated.
• Current diagnosis of substance abuse/dependence during the 6 months prior to study enrollment.
• Current diagnosis of uncontrolled hypertension, anemia, liver disease, kidney disease, stroke, and autoimmune disease. Based on the clinical judgment of the study PI, a risk assessment will be conducted if a participant endorses any of these diagnoses but would be otherwise a suitable participant to enroll in the study.
• Current acute infection/infectious disease (i.e., a cold or the flu). Based on the clinical judgement of the study PI, a risk assessment will be conducted if a participant endorses some acute infection/infectious disease, but would be otherwise suitable to enroll in the study following a brief wait period for full symptom remission.
• Pre- and peri-menopausal women (i.e., defined as the presence of ANY menstruation within the past 12 months).
• Certain steroids (e.g., use of hormonal birth control) and any systemic corticosteroids. Please note that hormone replacement therapy will be allowed along with any topical corticosteroid creams.

Sponsors & Collaborators

• Todd Doyle: lead
• Takeda: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (65)

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MeSH Terms

Conditions

Depressive Disorder, Major; Diabetes Mellitus, Type 2

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Todd Doyle, PhD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will receive a 10 or 20 mg dose of vortioxetine to take daily for 8 weeks. Study PI and sub-investigator (psychiatrist Murali Rao, MD) will determine appropriate dose.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 10, 2018
• Study Start: July 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)