Major Depressive Disorder
Conditions
Brief summary
On 6 Feb 2014, Pristiq was approved for the treatment of Major Depressive Disorder(MDD) in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS for 600 patients by 5 Feb 2020. Post marketing surveillance is required to determine any problems or questions associated with Pristiq after marketing, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of pristiq will be observed.
Detailed description
The objective of this study is to determine any problems or questions associated with Pristiq after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation Re-examination guideline of new drugs (Ministry of Food and Drug Safety Notification 2013-251, 2013.12.20). 1. Serious adverse event/adverse drug reaction 2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label. 3. Known adverse drug reaction 4. Non-serious adverse drug reaction 5. Other safety and effectiveness information
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults 19 years of age or older, who have been received at least one dose of PRISTIQ® for the treatment of Major depressive disorder (MDD). 2. Patients who have been received for the first time after signed the 'data privacy statement'
Exclusion criteria
Patients to whom PRISTIQ® is contraindicated as per the local labeling; 1. Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ® formulation. 2. Serotonin syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ® or Do not use PRISTIQ® within 14 days of stopping an MAOI intended to treat psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 8 weeks | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | At Week 8 | CGI-I scale was a 7-point scale used to assess clinical effectiveness on a range of 1 to 7; where, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = No change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition/lower clinical effectiveness. |
| Number of Participants With Final Effectiveness Evaluation | At Week 8 | Final effectiveness was evaluated as 'improved', 'no change', 'worse' or 'unevaluable' based on overall participant's clinical response after 8 weeks of Pristiq administration (as part of routine care), where, Improved = there was the improvement of symptoms related to major depressive disorder, No change = there was no significant change compared to participant's status before Pristiq administration, Worse = symptoms were getting worse compared to participant's status before Pristiq administration, Unevaluable = the medical charts do not had adequate progress notes to make a judgment on clinical response. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pristiq Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration. | 700 |
| Total | 700 |
Baseline characteristics
| Characteristic | Pristiq | — |
|---|---|---|
| Age, Continuous | 58.23 years STANDARD_DEVIATION 17.67 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 455 Participants | — |
| Sex: Female, Male Male | 245 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 700 |
| other Total, other adverse events | 80 / 700 |
| serious Total, serious adverse events | 3 / 700 |
Outcome results
Primary
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
CGI-I scale was a 7-point scale used to assess clinical effectiveness on a range of 1 to 7; where, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = No change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition/lower clinical effectiveness.
Time frame: At Week 8
Population: Effectiveness analysis set included all participants who had been administered Pristiq at least once and were evaluated upon its related effectiveness outcomes at least once. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pristiq | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | Very much improved | 22 Participants |
| Pristiq | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | Much improved | 128 Participants |
| Pristiq | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | Minimally improved | 237 Participants |
| Pristiq | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | No change | 65 Participants |
| Pristiq | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | Minimally worse | 2 Participants |
| Pristiq | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | Much worse | 0 Participants |
| Pristiq | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale | Very much worse | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to 8 weeks
Population: Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pristiq | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 80 Participants |
| Pristiq | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
Primary
Number of Participants With Final Effectiveness Evaluation
Final effectiveness was evaluated as 'improved', 'no change', 'worse' or 'unevaluable' based on overall participant's clinical response after 8 weeks of Pristiq administration (as part of routine care), where, Improved = there was the improvement of symptoms related to major depressive disorder, No change = there was no significant change compared to participant's status before Pristiq administration, Worse = symptoms were getting worse compared to participant's status before Pristiq administration, Unevaluable = the medical charts do not had adequate progress notes to make a judgment on clinical response.
Time frame: At Week 8
Population: Effectiveness analysis set included all participants who had been administered Pristiq at least once and were evaluated upon its related effectiveness outcomes at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pristiq | Number of Participants With Final Effectiveness Evaluation | Improved | 411 Participants |
| Pristiq | Number of Participants With Final Effectiveness Evaluation | No change | 68 Participants |
| Pristiq | Number of Participants With Final Effectiveness Evaluation | Worse | 0 Participants |
| Pristiq | Number of Participants With Final Effectiveness Evaluation | Unevaluable | 0 Participants |