Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03580967
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.
Study:
NCT03580967
Study Brief:
Protocol Section:
NCT03580967