Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

Viatris

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Venlafaxine ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485887

B2411264

Details and patient eligibility

About

This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.

Exclusion criteria

• Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study.
• Significant risk of suicide based on clinical judgment.
• Use of prohibited treatments

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Venlafaxine ER

Experimental group

Treatment:

Drug: Venlafaxine ER