Major Depressive Disorder, Type2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Major Depressive Disorder, Vortioxetine
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.
Detailed description
This will be a 9-week, open-label, single-arm, pilot investigation for Type 2 Diabetes (T2D) patients with Major Depressive Disorder (MDD). The study includes a screening visit, a 1-week washout phase (or 30-day washout phase for serotonergic agents), and an 8-week flexible dose phase that includes the baseline and post-treatment follow-up visits. A minimum of N=70 participants will be enrolled in the treatment. At the screening visit, the study will be explained and the informed consent process will take place. Patients who sign the IRB-approved consent form will undergo a psychiatric interview. The diagnosis of MDD will be established in this examination using the psychiatric interview and Hamilton Depression Rating Scale (HAM-D) by the study PI. Eligible participants will be instructed how to taper the antidepressant they have been taking (if relevant) over the course of the one-week (or 30-days for serotonergic agents). After these tapers, all participants will return for a baseline visit where they will be re-assessed to ensure persistent depressive symptoms. If patients continue to score ≥18 on the HAM-D, they will complete the psychosocial questionnaires; patients scoring below \<18 on the HAM-D at this visit will be terminated from the study and offered conventional, standard of care treatment within LUMC Department of Psychiatry. Once participants are given the psychosocial questionnaires as part of the baseline visit, a blood draw will be conducted by the Study Nurse/Coordinator, and MRI scans will be completed. At the end of the baseline session, participants will receive Vortioxetine for the remaining 8-week flexible dosing period (i.e., 10 mg to 20 mg dosing). In the instance a patient is unable to tolerate either 10 mg to 20 mg of Vortioextine (as reported in the medication packet insert), the patient will be allowed to reduce their dosage to 5 mg, which will be done in consultation with the PI and sub-investigator. Following the 8-week intervention, participants will be scheduled for the post visit, which will include the following: another clinical interview and HAM-D conducted by the PI, completion of post visit-related psychosocial questionnaires, a second blood draw conducted by the Study Nurse/Coordinator, and then post visit-MRI scans will be completed. Should any patients continue to score \>18 on the HAM-D at study conclusion, resources and referrals will be provided for further psychological/psychiatric interventions, as needed.
Interventions
DRUGVortioxetine
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.
Sponsors
Takeda
Todd Doyle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D) | Baseline and End of Treatment visit (Week 8) | 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. |
Countries
United States
Outcome results
None listed