Trial intelligence / Profile preview

Venlafaxine ER Long-term Extension in MDD

NCT01485887Phase 3

Key facts

Status: Completed
Start: Jan 2012
Primary completion: Jan 2014
Countries: 1
Sponsor: Viatris
Modality: Small Molecules

Drugs: venlafaxine
Conditions: major depressive disorder (MDD)

Overview

Phase 3, open-label, single-arm trial of venlafaxine in major depressive disorder (MDD), sponsored by Viatris. Primary endpoints: Adverse Events and Serious Adverse Events at 10 months, Clinical Significant Vital Changes at 10 months and 3 more. Started Jan 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Venlafaxine ER
Venlafaxine ER flexible dose (75-225 mg/day)

Who it enrols

Adult outpatients with Major Depressive Disorder who completed the prior double-blind study (B2411263) without major protocol violations or tolerability concerns.

Endpoints

Primary

Adverse Events and Serious Adverse Events10 months
Clinical Significant Vital Changes10 months
Clinical Significant Laboratory Tests Changes10 months
Clinical Significant Electrocardiogram Changes10 months
Columbia Suicide-Severity Rating Scale10 months

Secondary

17-item Hamilton Rating Scale for DepressionWeeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
Clinical Global Impression - SeverityWeeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
Clinical Global Impression - ImprovementWeeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese VersionWeeks 12, 24, 44

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