Major Depressive Disorder, Vasomotor Symptoms
Conditions
Brief summary
This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.
Detailed description
post marketing surveillance none
Interventions
50 mg tablet once daily
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate
Exclusion criteria
Hypersensitivity to desvenlafaxine succinate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) | Week 4 to Week 8 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with 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; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state. |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. | Week 4 | — |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. | Week 8 | — |
| Change From Baseline in Heart Rate at Week 4. | Week 4 | — |
| Change From Baseline in Heart Rate at Week 8. | Week 8 | — |
| Change From Baseline in Weight at Week 4. | Week 4 | — |
| Change From Baseline in Weight at Week 8. | Week 8 | — |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desvenlafaxine Succinate Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | Desvenlafaxine Succinate |
|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 13.5 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Change From Baseline in Heart Rate at Week 4.
Time frame: Week 4
Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desvenlafaxine Succinate | Change From Baseline in Heart Rate at Week 4. | 1.9 beats per minute (bpm) | Standard Deviation 4.5 |
Primary
Change From Baseline in Heart Rate at Week 8.
Time frame: Week 8
Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desvenlafaxine Succinate | Change From Baseline in Heart Rate at Week 8. | 0.6 bpm | Standard Deviation 5.59 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
Time frame: Week 4
Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desvenlafaxine Succinate | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. | Change from baseline in systolic BP at Week 4 | -0.5 millimeter of mercury (mmHg) | Standard Deviation 8.69 |
| Desvenlafaxine Succinate | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. | Change from baseline in diastolic BP at Week 4 | -0.5 millimeter of mercury (mmHg) | Standard Deviation 9.6 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
Time frame: Week 8
Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desvenlafaxine Succinate | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. | Change from baseline in systolic BP at Week 8 | -0.7 millimeter of mercury (mmHg) | Standard Deviation 7.06 |
| Desvenlafaxine Succinate | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. | Change from baseline in diastolic BP at Week 8 | -1.8 millimeter of mercury (mmHg) | Standard Deviation 13.28 |
Primary
Change From Baseline in Weight at Week 4.
Time frame: Week 4
Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desvenlafaxine Succinate | Change From Baseline in Weight at Week 4. | 0.1 kilogram (kg) | Standard Deviation 1.61 |
Primary
Change From Baseline in Weight at Week 8.
Time frame: Week 8
Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desvenlafaxine Succinate | Change From Baseline in Weight at Week 8. | 0.5 kg | Standard Deviation 1.69 |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with 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; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 4 to Week 8
Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desvenlafaxine Succinate | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) | Participants w ith AEs | 5 Participants |
| Desvenlafaxine Succinate | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) | Participants w ith SAEs | 0 Participants |
| Desvenlafaxine Succinate | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) | Participants discontinued due to AEs | 2 Participants |