Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03580967
Study type Interventional
Source Loyola University
Contact Todd Doyle, PhD
Phone 708-216-4303
Status Not yet recruiting
Phase Phase 4
Start date January 1, 2019
Completion date August 1, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Suspended NCT02940769 - Neurobiological Effects of Light on MDD Early Phase 1
Recruiting NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT03708159 - Maintenance of Response After rTMS for Depression Using tDCS N/A
Recruiting NCT03363919 - Biomarkers in Repetitive Transcranial Magnetic Stimulation (rTMS) for Adolescent Depression N/A
Recruiting NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Recruiting NCT03113890 - McLean and Genomind Prospective Study N/A
Recruiting NCT02674529 - Study of Neural Responses Induced by Antidepressant Effects Phase 2/Phase 3
Active, not recruiting NCT02934035 - Early Improvement in Individual Symptoms and Response to Antidepressants in Patients With Major Depressive Disorder N/A
Completed NCT02855580 - Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic
Completed NCT02309060 - Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial N/A
Completed NCT02939560 - TMS for Adults With Autism and Depression N/A
Not yet recruiting NCT02766920 - Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone N/A
Recruiting NCT02530164 - Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression N/A
Recruiting NCT02624102 - Efficacy of Trial-Based Cognitive Therapy and Behavioral Activation in Treatment of Depression Phase 3
Recruiting NCT02922556 - Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD) N/A
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study N/A
Not yet recruiting NCT02502604 - Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder N/A
Withdrawn NCT01613820 - Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder N/A
Recruiting NCT03265340 - Clinical Effect of dTMS in Major Depressive Disorder N/A