N/A
N=1,408
Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)
Depression/Depressed State
Bottom Line
View on ClinicalTrials.gov: NCT02958527 ↗Enrolled (actual)
1,408
Serious AEs
1.5%
Results posted
May 2021
Primary outcome: Primary: Number of Participants With Adverse Drug Reactions — 312; 4 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- venlafaxine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
312; 4 | — |
| SECONDARY Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points |
-6.0; -9.1; -12.3; -11.2; -12.0; -12.2 | — |
| SECONDARY Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points |
-7.5; -11.6; -15.4; -15.0; -13.9; -15.7 | — |
| SECONDARY Clinical Global Impressions-Severity |
0; 2; 19; 56; 9; 7 | — |
| SECONDARY Changes in the Clinical Global Impressions-Improvement |
199; 235; 175; 178; 212; 88 | — |
Summary
SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE
Eligibility Criteria
Inclusion Criteria
- Patients with no experience of using this product who will be administered this product for the first time
Exclusion Criteria
- Exclusion criteria are not provided in this study
Data sourced from ClinicalTrials.gov (NCT02958527). 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.