Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes

This is an interventional treatment trial for Type2 Diabetes focused on measuring Type 2 Diabetes, Major Depressive Disorder, Vortioxetine Read More

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.).

MRI-Related Exclusion Criteria

• 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

Exclusion Criteria to Reduce False Positive Rates of Inflammation

• 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.
• Patients currently enrolled in any other clinical trial for treatment of MDD (e.g., patients receiving experimental vitamin D supplementation).