Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    11375373 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03580967
Recruitment Status : Not yet recruiting
First Posted : July 10, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Todd Doyle, Loyola University

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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Major Depressive Disorder Drug: Vortioxetine Phase 4

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.


Layout table for study information
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Drug: Vortioxetine Drug: Vortioxetine
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Todd Doyle, PhD 708-216-4303 todddoyle1@lumc.edu

Locations
Layout table for location information
United States, Illinois
Loyola University Medical Center Not yet recruiting
Maywood, Illinois, United States, 60153
Contact: Todd Doyle, PhD    708-216-4303    todddoyle1@lumc.edu   
Sponsors and Collaborators
Todd Doyle
Takeda
Investigators
Layout table for investigator information
Principal Investigator: Todd Doyle, PhD Loyola University Chicago

Publications:
Centers for Disease Control and Prevention, National Diabetes Statistics Report. National diabetes statistics report. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. (2017).
Westrih I, Rehrson A, & Zhong H, et al. In vitro and in vivo effects for the multimodal antidepressant vortioxetine (Lu AA21004) at human and rat targets. International Journal of Psychiatry and Clinical Practice 2012; 16 (S1): 47.
Cohen, J. (1988). Statistical Power Analyses for the Behavioral Sciences (2nd Edition). Psychology Press. Taylor & Francis Group.

Layout table for additonal information
Responsible Party: Todd Doyle, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03580967     History of Changes
Other Study ID Numbers: 210161
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Todd Doyle, Loyola University:
Type 2 Diabetes
Major Depressive Disorder
Vortioxetine

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists