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Selective Serotonin Reuptake Inhibitor

Drug: Vortioxetine for Type 2 Diabetes

Phase 4
Waitlist Available
Led By Todd Doyle, PhD
Research Sponsored by Todd Doyle
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and end of treatment visit (week 8)
Awards & highlights

Study Summary

This trial will enroll participants who have been diagnosed with type 2 diabetes and are experiencing symptoms of depression. The study will look at the effects of vortioxetine on depression symptoms and stress response.

Eligible Conditions
  • Depression
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and end of treatment visit (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end of treatment visit (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D)

Side effects data

From 2019 Phase 4 trial • 1106 Patients • NCT02371980
26%
Nausea
8%
Headache
5%
Nasopharyngitis
5%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label: Vortioxetine 10 mg
Double-blind: Placebo
Double-blind: Vortioxetine 5 mg
Double-blind: Vortioxetine 10 mg
Double-blind: Vortioxetine 20 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Drug: VortioxetineExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vortioxetine
FDA approved

Find a Location

Who is running the clinical trial?

Todd DoyleLead Sponsor
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,178,025 Total Patients Enrolled
Todd Doyle, PhDPrincipal InvestigatorLoyola University Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Quality of Life ResearchJournal
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Jacobson, A. M.. 1997. “[]”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1023/a:1026487509852.
Molecular PsychiatryJournal
Mood Is Indirectly Related to Serotonin, Norepinephrine and Dopamine Levels in Humans: A Meta-analysis of Monoamine Depletion Studies
Ruhé, H G, N S Mason, and A H Schene. 2007. “Mood Is Indirectly Related to Serotonin, Norepinephrine and Dopamine Levels in Humans: A Meta-analysis of Monoamine Depletion Studies”. Molecular Psychiatry. Springer Science and Business Media LLC. doi:10.1038/sj.mp.4001949.
Current Diabetes ReportsJournal
Shared Neurobiological Pathways Between Type 2 Diabetes and Depressive Symptoms: A Review of Morphological and Neurocognitive Findings
Doyle, Todd, Angelos Halaris, and Murali Rao. 2014. “Shared Neurobiological Pathways Between Type 2 Diabetes and Depressive Symptoms: A Review of Morphological and Neurocognitive Findings”. Current Diabetes Reports. Springer Science and Business Media LLC. doi:10.1007/s11892-014-0560-7.
Metabolic Brain DiseaseJournal
The Inflammatory & Neurodegenerative (i&nd) Hypothesis of Depression: Leads for Future Research and New Drug Developments in Depression
Maes, Michael, Raz Yirmyia, Jens Noraberg, Stefan Brene, Joe Hibbeln, Giulia Perini, Marta Kubera, Petr Bob, Bernard Lerer, and Mario Maj. 2008. “The Inflammatory & Neurodegenerative (i&nd) Hypothesis of Depression: Leads for Future Research and New Drug Developments in Depression”. Metabolic Brain Disease. Springer Science and Business Media LLC. doi:10.1007/s11011-008-9118-1.
~0 spots leftby Apr 2025
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