Last reviewed · How we verify
NCT03580967
Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes
Phase 4 trial testing Vortioxetine in Type2 Diabetes. Withdrawn.
1 July 2021
Quick facts
| Lead sponsor | Todd Doyle |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 July 2019 |
| Primary completion | 1 July 2021 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vortioxetine (vortioxetine) — full drug profile →
Conditions studied
- Type2 Diabetes — all drugs for Type2 Diabetes →
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Todd Doyle
Who can join
Adults 40 to 65, any sex, with Type2 Diabetes or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03580967
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vortioxetine
Trials testing the same drug.
- NCT07266545 — RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) · Phase 4 · recruiting
- NCT06604520 — Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia · Phase 2 · recruiting
- NCT05814640 — Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) · Phase 1, PHASE2 · recruiting
- NCT04446039 — Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea · completed
- NCT05481957 — Vortioxetine Adjunctive Treatment in Bipolar Depression · Phase 4 · completed
Other recruiting trials for Type2 Diabetes
Currently open trials in the same condition.
- NCT05277558 — Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D) · recruiting
- NCT05015283 — Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission · NA · recruiting
- NCT05006508 — Prevention With the Health and Lifestyle Tool · NA · active not recruiting
- NCT04717050 — Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity · NA · active not recruiting
- NCT05220917 — Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03580967 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Todd Doyle
- Last refreshed: 29 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03580967.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing