Overview

Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

Status:
Completed

Trial end date:
2011-03-01

Target enrollment:
0

Participant gender:
All

Summary

The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD). The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Desvenlafaxine Succinate

Criteria

Inclusion Criteria:

- Outpatients who have completed double-blind therapy in short-term study for the
indication of major depressive disorder (MDD), including scheduled evaluations, with
no major protocol violations and no study events that, in the opinion of the
investigator, would preclude the subject's entry into the long-term, open-label study.

Exclusion Criteria:

- Clinically important abnormalities on baseline (day 56 of the short-term study)
physical examination, or any unresolved clinically significant abnormalities on
electrocardiogram (ECG), laboratory test results, or vital signs recorded before day
56 in the previous short-term study for the indication of MDD.