Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT03580967|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2018
Last Update Posted : March 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes Major Depressive Disorder||Drug: Vortioxetine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes: Role of Inflammation, Kynurenine Pathway, and Structural and Functional Brain Connectivity as Biomarkers|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2023|
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.
Other Name: Trintellix
- Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580967
|Contact: Todd Doyle, PhDfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Not yet recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Todd Doyle, PhD 708-216-4303 email@example.com|
|Principal Investigator:||Todd Doyle, PhD||Loyola University Chicago|