NCT02969876: VOR-IISR

Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

Terminated Phase 4 Results posted Last updated 14 October 2019

What this trial tests

Phase 4 trial testing Vortioxetine in Depressive Disorder in 2 participants. Terminated before completion.

Timeline

24 August 2017

Primary endpoint
6 August 2018

6 August 2018

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	2
Start date	24 August 2017
Primary completion	6 August 2018
Estimated completion	6 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Vortioxetine (vortioxetine) — full drug profile →

Conditions studied

• Depressive Disorder — all drugs for Depressive Disorder →
• Major Depression — all drugs for Major Depression →
• Depression — all drugs for Depression →
• Depression, Unipolar — all drugs for Depression, Unipolar →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with Depressive Disorder or Major Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C) Primary · 6 weeks

This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.

Group	Value	95% CI
Study Phase	12.5	± 10.60

Digital Symbol Substitution Test Secondary · 6 weeks

A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.

Group	Value	95% CI
Open Trial Vortioxetine	41.5	± 1.5

Rey Auditory Verbal Learning Test Secondary · 6 weeks

A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome

Group	Value	95% CI
Open Trial Vortioxetine	54	± 1

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open Trial Vortioxetine

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (3 terms — click to expand)

Reaction	System	Open Trial Vortioxetine
Tripped, hit knee, went to ER	Musculoskeletal and connective tissue disorders	—
Migraines	General disorders	—
Headaches	General disorders	—

Data from ClinicalTrials.gov NCT02969876 adverse events section.

Sponsor's own description

The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vortioxetine Improves Context Discrimination in Mice Through a Neurogenesis Independent Mechanism.
   Felice D, Guilloux JP, Pehrson A, Li Y, et al · · 2018 · cited 10× · PMID 29593535 · DOI 10.3389/fphar.2018.00204