Type2 DiabetesPhase 4NCT03580967
Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes
A Phase 4 study testing Vortioxetine in people with Type2 Diabetes and Major Depressive Disorder, run by Todd Doyle at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type2 Diabetes, Major Depressive Disorder
- What is being tested?
- Vortioxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
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
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.
Read the 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.
- Conditions
- Type2 Diabetes, Major Depressive Disorder
- Being tested
- Vortioxetine
- Keywords
- Type 2 Diabetes, Major Depressive Disorder, Vortioxetine
- Medical subject headings
- Depressive Disorder, Major, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Trintellix
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Vortioxetine | Other | Not described Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D)
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.
Measured: Baseline and End of Treatment visit (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Jul 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: COVID-19 Pandemic interfered with Pt recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Todd Doyle
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor-investigator, Todd Doyle, Loyola University
- Investigators
- Todd Doyle, PhD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580967
- Sponsor's protocol ID
- 210161
- Status last verified
- Nov 2022
- First submitted
- 25 Jun 2018
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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).
Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001 Jun;24(6):1069-78. doi: 10.2337/diacare.24.6.1069.
PubMed 11375373Gavard JA, Lustman PJ, Clouse RE. Prevalence of depression in adults with diabetes. An epidemiological evaluation. Diabetes Care. 1993 Aug;16(8):1167-78. doi: 10.2337/diacare.16.8.1167.
PubMed 8375247de Groot M, Doyle T, Hockman E, Wheeler C, Pinkerman B, Shubrook J, Gotfried R, Schwartz F. Depression among type 2 diabetes rural Appalachian clinic attendees. Diabetes Care. 2007 Jun;30(6):1602-4. doi: 10.2337/dc06-1599. Epub 2007 Mar 12. No abstract available.
PubMed 17353505Lustman PJ, Anderson RJ, Freedland KE, de Groot M, Carney RM, Clouse RE. Depression and poor glycemic control: a meta-analytic review of the literature. Diabetes Care. 2000 Jul;23(7):934-42. doi: 10.2337/diacare.23.7.934.
PubMed 10895843de Groot M, Anderson R, Freedland KE, Clouse RE, Lustman PJ. Association of depression and diabetes complications: a meta-analysis. Psychosom Med. 2001 Jul-Aug;63(4):619-30. doi: 10.1097/00006842-200107000-00015.
PubMed 11485116Ciechanowski PS, Katon WJ, Russo JE. Depression and diabetes: impact of depressive symptoms on adherence, function, and costs. Arch Intern Med. 2000 Nov 27;160(21):3278-85. doi: 10.1001/archinte.160.21.3278.
PubMed 11088090Jacobson AM, de Groot M, Samson JA. The effects of psychiatric disorders and symptoms on quality of life in patients with type I and type II diabetes mellitus. Qual Life Res. 1997 Jan;6(1):11-20. doi: 10.1023/a:1026487509852.
PubMed 9062437Egede LE, Osborn CY. Role of motivation in the relationship between depression, self-care, and glycemic control in adults with type 2 diabetes. Diabetes Educ. 2010 Mar-Apr;36(2):276-83. doi: 10.1177/0145721710361389. Epub 2010 Feb 23.
PubMed 20179250Katon W, von Korff M, Ciechanowski P, Russo J, Lin E, Simon G, Ludman E, Walker E, Bush T, Young B. Behavioral and clinical factors associated with depression among individuals with diabetes. Diabetes Care. 2004 Apr;27(4):914-20. doi: 10.2337/diacare.27.4.914.
PubMed 15047648Katon WJ, Rutter C, Simon G, Lin EH, Ludman E, Ciechanowski P, Kinder L, Young B, Von Korff M. The association of comorbid depression with mortality in patients with type 2 diabetes. Diabetes Care. 2005 Nov;28(11):2668-72. doi: 10.2337/diacare.28.11.2668.
PubMed 16249537Egede LE, Zheng D, Simpson K. Comorbid depression is associated with increased health care use and expenditures in individuals with diabetes. Diabetes Care. 2002 Mar;25(3):464-70. doi: 10.2337/diacare.25.3.464.
PubMed 11874931Baumeister H, Hutter N, Bengel J. Psychological and pharmacological interventions for depression in patients with diabetes mellitus and depression. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD008381. doi: 10.1002/14651858.CD008381.pub2.
PubMed 23235661van der Feltz-Cornelis CM, Nuyen J, Stoop C, Chan J, Jacobson AM, Katon W, Snoek F, Sartorius N. Effect of interventions for major depressive disorder and significant depressive symptoms in patients with diabetes mellitus: a systematic review and meta-analysis. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):380-95. doi: 10.1016/j.genhosppsych.2010.03.011. Epub 2010 May 15.
PubMed 20633742Champaneri S, Wand GS, Malhotra SS, Casagrande SS, Golden SH. Biological basis of depression in adults with diabetes. Curr Diab Rep. 2010 Dec;10(6):396-405. doi: 10.1007/s11892-010-0148-9.
PubMed 20878274
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03580967
- Acronym / sponsor ID
- 210161
- Conditions
- Type2 Diabetes, Major Depressive Disorder
- Keywords
- Type 2 Diabetes, Major Depressive Disorder, Vortioxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Pandemic interfered with Pt recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Todd DoyleUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Drug: Vortioxetine | Other | Drug: Vortioxetine |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: TrintellixOral 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. | Drug | Drug: Vortioxetine |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- BackgroundCenters 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).
- Background: PubMed 11375373Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001 Jun;24(6):1069-78. doi: 10.2337/diacare.24.6.1069.
- Background: PubMed 8375247Gavard JA, Lustman PJ, Clouse RE. Prevalence of depression in adults with diabetes. An epidemiological evaluation. Diabetes Care. 1993 Aug;16(8):1167-78. doi: 10.2337/diacare.16.8.1167.
- Background: PubMed 17353505de Groot M, Doyle T, Hockman E, Wheeler C, Pinkerman B, Shubrook J, Gotfried R, Schwartz F. Depression among type 2 diabetes rural Appalachian clinic attendees. Diabetes Care. 2007 Jun;30(6):1602-4. doi: 10.2337/dc06-1599. Epub 2007 Mar 12. No abstract available.
- Background: PubMed 10895843Lustman PJ, Anderson RJ, Freedland KE, de Groot M, Carney RM, Clouse RE. Depression and poor glycemic control: a meta-analytic review of the literature. Diabetes Care. 2000 Jul;23(7):934-42. doi: 10.2337/diacare.23.7.934.
- Background: PubMed 11485116de Groot M, Anderson R, Freedland KE, Clouse RE, Lustman PJ. Association of depression and diabetes complications: a meta-analysis. Psychosom Med. 2001 Jul-Aug;63(4):619-30. doi: 10.1097/00006842-200107000-00015.
- Background: PubMed 11088090Ciechanowski PS, Katon WJ, Russo JE. Depression and diabetes: impact of depressive symptoms on adherence, function, and costs. Arch Intern Med. 2000 Nov 27;160(21):3278-85. doi: 10.1001/archinte.160.21.3278.
- Background: PubMed 9062437Jacobson AM, de Groot M, Samson JA. The effects of psychiatric disorders and symptoms on quality of life in patients with type I and type II diabetes mellitus. Qual Life Res. 1997 Jan;6(1):11-20. doi: 10.1023/a:1026487509852.
- Background: PubMed 20179250Egede LE, Osborn CY. Role of motivation in the relationship between depression, self-care, and glycemic control in adults with type 2 diabetes. Diabetes Educ. 2010 Mar-Apr;36(2):276-83. doi: 10.1177/0145721710361389. Epub 2010 Feb 23.
- Background: PubMed 15047648Katon W, von Korff M, Ciechanowski P, Russo J, Lin E, Simon G, Ludman E, Walker E, Bush T, Young B. Behavioral and clinical factors associated with depression among individuals with diabetes. Diabetes Care. 2004 Apr;27(4):914-20. doi: 10.2337/diacare.27.4.914.
- Background: PubMed 16249537Katon WJ, Rutter C, Simon G, Lin EH, Ludman E, Ciechanowski P, Kinder L, Young B, Von Korff M. The association of comorbid depression with mortality in patients with type 2 diabetes. Diabetes Care. 2005 Nov;28(11):2668-72. doi: 10.2337/diacare.28.11.2668.
- Background: PubMed 11874931Egede LE, Zheng D, Simpson K. Comorbid depression is associated with increased health care use and expenditures in individuals with diabetes. Diabetes Care. 2002 Mar;25(3):464-70. doi: 10.2337/diacare.25.3.464.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Doyle, PhD principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine in people with Type2 Diabetes and Major Depressive Disorder, run by Todd Doyle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D) (time frame: Baseline and End of Treatment visit (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580967, which also lists 65 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.