Phase 3
Completed N=304
Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT00831415 ↗Enrolled (actual)
304
Serious AEs
2.6%
Results posted
Jan 2012
Primary outcomePrimary: Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score — -4.76; -5.82 scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score |
-4.76; -5.82 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) |
81.3; 2.6 | — |
| SECONDARY Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I) |
164; 82; 36; 15; 6; 1 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score |
-0.82; -0.95 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00831415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.