Trial Outcomes & Findings for Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression (NCT NCT02285504)
NCT ID: NCT02285504
Last Updated: 2025-09-15
Results Overview
AEs were any untoward medical occurrences in a participant who received study treatment without regard to possibility of causal relationship. TEAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 7 days after the end of infusion (Day 11). TESAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 30 days after the end of infusion (Day 34).
COMPLETED
PHASE2
4 participants
TEAEs: Up to Day 11, TESAEs: Up to Day 34
2025-09-15
Participant Flow
Participants were enrolled in the study at 1 center in the United States from 07 January 2015 to 05 June 2015.
A total of 6 participants were screened, 4 participants were treated and completed the study. This study consisted of up to a 3-day screening period, a 4-day (84-hour) active treatment period, a 7-day adverse event (AE) follow-up period, plus an additional 23 days of serious AE follow-up (with a telephone call at Day 11 and Day 34).
Participant milestones
| Measure |
SAGE-547
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms per kilogram per hour \[mcg/kg/hr\] \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Baseline characteristics by cohort
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 6.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TEAEs: Up to Day 11, TESAEs: Up to Day 34Population: Safety population included all participants who began infusion with SAGE-547 injection.
AEs were any untoward medical occurrences in a participant who received study treatment without regard to possibility of causal relationship. TEAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 7 days after the end of infusion (Day 11). TESAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 30 days after the end of infusion (Day 34).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Chemistry (ALT, AST, GGT) expressed in terms of units per liter (U/L). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 2 (24 hrs): ALT
|
-3.0 U/L
Standard Deviation 4.69
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 3 (48 hrs): ALT
|
-3.7 U/L
Standard Deviation 7.02
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 4 (84 hrs): ALT
|
2.7 U/L
Standard Deviation 2.08
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 2 (24 hrs): AST
|
-0.5 U/L
Standard Deviation 6.19
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 3 (48 hrs): AST
|
1.0 U/L
Standard Deviation 6.24
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 4 (84 hrs): AST
|
4.7 U/L
Standard Deviation 5.69
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 2 (24 hrs): GGT
|
-0.7 U/L
Standard Deviation 2.08
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 3 (48 hrs): GGT
|
-2.0 U/L
Standard Deviation 1.41
|
|
Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Change From Baseline at Day 4 (84 hrs): GGT
|
5.5 U/L
Standard Deviation 9.19
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Chemistry (carbon dioxide \[CO2\], sodium, potassium and chloride) expressed in terms of millimoles/liter (mmol/L). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 3 (48 hrs): Chloride
|
-1.3 mmol/L
Standard Deviation 5.03
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 4 (84 hrs): Chloride
|
-1.3 mmol/L
Standard Deviation 6.03
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 2 (24 hrs): CO2
|
-0.5 mmol/L
Standard Deviation 3.42
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 3 (48 hrs): CO2
|
-2.0 mmol/L
Standard Deviation 3.61
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 4 (84 hrs): CO2
|
-3.0 mmol/L
Standard Deviation 4.58
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 2 (24 hrs): Sodium
|
-0.5 mmol/L
Standard Deviation 1.00
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 3 (48 hrs): Sodium
|
-1.3 mmol/L
Standard Deviation 2.08
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 4 (84 hrs): Sodium
|
1.3 mmol/L
Standard Deviation 2.52
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 2 (24 hrs): Potassium
|
0.25 mmol/L
Standard Deviation 0.208
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 3 (48 hrs): Potassium
|
0.20 mmol/L
Standard Deviation 0.100
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 4 (84 hrs): Potassium
|
0.47 mmol/L
Standard Deviation 0.115
|
|
Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Change From Baseline at Day 2 (24 hrs): Chloride
|
-0.5 mmol/L
Standard Deviation 5.00
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Chemistry (glucose, total bilirubin, calcium, blood urea nitrogen \[BUN\] and creatinine) expressed in terms of milligrams/deciliter (mg/dL). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 2 (24 hrs): Calcium
|
-0.28 mg/dL
Standard Deviation 0.532
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 4 (84 hrs): Calcium
|
0.30 mg/dL
Standard Deviation 0.265
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 2 (24 hrs): BUN
|
0.5 mg/dL
Standard Deviation 1.29
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 3 (48 hrs): BUN
|
0.3 mg/dL
Standard Deviation 4.51
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 4 (84 hrs): BUN
|
0.0 mg/dL
Standard Deviation 4.58
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 2 (24 hrs): Creatinine
|
-0.010 mg/dL
Standard Deviation 0.0698
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 3 (48 hrs): Creatinine
|
-0.050 mg/dL
Standard Deviation 0.0721
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 4 (84 hrs): Creatinine
|
-0.057 mg/dL
Standard Deviation 0.1159
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 4 (84 hrs): Glucose
|
17.7 mg/dL
Standard Deviation 13.58
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 2 (24 hrs): Total Bilirubin
|
-0.05 mg/dL
Standard Deviation 0.129
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 3 (48 hrs): Total Bilirubin
|
-0.23 mg/dL
Standard Deviation 0.153
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 4 (84 hrs): Total Bilirubin
|
-0.13 mg/dL
Standard Deviation 0.115
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 2 (24 hrs): Glucose
|
16.0 mg/dL
Standard Deviation 15.90
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 3 (48 hrs): Glucose
|
28.3 mg/dL
Standard Deviation 31.37
|
|
Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Change at Day 3 (48 hrs): Calcium
|
-0.03 mg/dL
Standard Deviation 0.802
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Chemistry (albumin, total protein), Hematology and Coagulation (hemoglobin) expressed in terms of g/dL. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 2 (24 hrs): Albumin
|
-0.40 g/dL
Standard Deviation 0.497
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 3 (48 hrs): Albumin
|
-0.33 g/dL
Standard Deviation 0.551
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 4 (84 hrs): Albumin
|
0.20 g/dL
Standard Deviation 0.173
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 2 (24 hrs): Total Protein
|
-0.63 g/dL
Standard Deviation 0.499
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 2 (24 hrs): Hemoglobin
|
0.02 g/dL
Standard Deviation 0.943
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 3 (48 hrs): Hemoglobin
|
-0.10 g/dL
Standard Deviation 0.954
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 4 (84 hrs): Hemoglobin
|
0.27 g/dL
Standard Deviation 0.306
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 3 (48 hrs): Total Protein
|
-0.43 g/dL
Standard Deviation 0.702
|
|
Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Change at Day 4 (84 hrs): Total Protein
|
0.20 g/dL
Standard Deviation 0.361
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Hematocrit expressed in terms of percentage. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measure: Hematocrit
Change From Baseline at Day 4 (84 hrs)
|
1.20 percentage of hematocrit
Standard Deviation 1.311
|
|
Change From Baseline in Clinical Laboratory Measure: Hematocrit
Change From Baseline at Day 2 (24 hrs)
|
0.15 percentage of hematocrit
Standard Deviation 2.199
|
|
Change From Baseline in Clinical Laboratory Measure: Hematocrit
Change From Baseline at Day 3 (48 hrs)
|
-1.07 percentage of hematocrit
Standard Deviation 1.914
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Platelet count, white blood cells (WBC), absolute lymphocytes, absolute neutrophils, absolute basophils, absolute eosinophils, absolute monocytes expressed in terms of 10\^9 cells/L. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 4 (84 hrs): Absolute Lymphocytes
|
-0.57 10^9 cells/L
Standard Deviation 0.737
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 2 (24 hrs): Absolute Neutrophils
|
-0.933 10^9 cells/L
Standard Deviation 0.2082
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 2 (24 hrs): Absolute Lymphocytes
|
-0.73 10^9 cells/L
Standard Deviation 0.764
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 3 (48 hrs): Absolute Lymphocytes
|
-0.50 10^9 cells/L
Standard Deviation 1.273
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 3 (48 hrs): Absolute Neutrophils
|
-1.250 10^9 cells/L
Standard Deviation 0.2121
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 4 (84 hrs): Absolute Neutrophils
|
-0.467 10^9 cells/L
Standard Deviation 0.2082
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 4 (84 hrs): Absolute Basophils
|
0.0 10^9 cells/L
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 2 (24 hrs): Absolute Eosinophils
|
0.03 10^9 cells/L
Standard Deviation 0.058
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 3 (48 hrs): Absolute Eosinophils
|
0.05 10^9 cells/L
Standard Deviation 0.071
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 4 (84 hrs): Absolute Eosinophils
|
0.00 10^9 cells/L
Standard Deviation 0.100
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 2 (24 hrs): Absolute Monocytes
|
-0.10 10^9 cells/L
Standard Deviation 0.100
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 4 (84 hrs): Absolute Monocytes
|
-0.07 10^9 cells/L
Standard Deviation 0.058
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 2 (24 hrs): Platelet Count
|
-18.8 10^9 cells/L
Standard Deviation 16.50
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 3 (48 hrs): Platelet Count
|
-23.3 10^9 cells/L
Standard Deviation 27.65
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 4 (84 hrs): Platelet Count
|
-4.3 10^9 cells/L
Standard Deviation 37.98
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 2 (24 hrs): WBC
|
-0.93 10^9 cells/L
Standard Deviation 1.910
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 3 (48 hrs): WBC
|
-0.03 10^9 cells/L
Standard Deviation 3.287
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 2 (24 hrs): Absolute Basophils
|
0.0 10^9 cells/L
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 3 (48 hrs): Absolute Basophils
|
0.0 10^9 cells/L
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 3 (48 hrs): Absolute Monocytes
|
-0.05 10^9 cells/L
Standard Deviation 0.071
|
|
Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Change at Day 4 (84 hrs): WBC
|
-1.07 10^9 cells/L
Standard Deviation 1.069
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: RBC expressed in terms of 10\^12 cells/L. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)
Change From Baseline at Day 2 (24 hrs)
|
-0.030 10^12 cells/L
Standard Deviation 0.1924
|
|
Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)
Change From Baseline at Day 3 (48 hrs)
|
-0.090 10^12 cells/L
Standard Deviation 0.2784
|
|
Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)
Change From Baseline at Day 4 (84 hrs)
|
0.113 10^12 cells/L
Standard Deviation 0.1656
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: MCV expressed in terms of femtoliters (fL). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)
Change From Baseline at Day 2 (24 hrs)
|
0.85 fL
Standard Deviation 1.578
|
|
Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)
Change From Baseline at Day 3 (48 hrs)
|
-0.53 fL
Standard Deviation 0.924
|
|
Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)
Change From Baseline at Day 4 (84 hrs)
|
0.33 fL
Standard Deviation 1.155
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: MCH expressed in terms of picogram (pg). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)
Change From Baseline at Day 2 (24 hrs)
|
-0.3 pg
Standard Deviation 1.15
|
|
Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)
Change From Baseline at Day 3 (48 hrs)
|
0.5 pg
Standard Deviation 0.71
|
|
Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)
Change From Baseline at Day 4 (84 hrs)
|
-0.3 pg
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: PT/INR expressed in terms of seconds. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)
Change From Baseline at Day 2 (24 hrs)
|
-0.30 seconds
Standard Deviation 0.700
|
|
Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)
Change From Baseline at Day 3 (48 hrs)
|
-1.05 seconds
Standard Deviation 0.636
|
|
Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)
Change From Baseline at Day 4 (84 hrs)
|
-0.37 seconds
Standard Deviation 0.902
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Urinalysis (pH). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)
Change From Baseline at Day 2 (24 hrs)
|
-0.17 pH
Standard Deviation 1.155
|
|
Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)
Change From Baseline at Day 3 (48 hrs)
|
0.33 pH
Standard Deviation 0.289
|
|
Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)
Change From Baseline at Day 4 (84 hrs)
|
1.00 pH
Standard Deviation 0.000
|
PRIMARY outcome
Timeframe: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Clinical laboratory evaluation included: Urinalysis (specific gravity) expressed in terms of ratio. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Clinical Laboratory Measure: Specific Gravity
Change From Baseline at Day 2 (24 hrs)
|
-0.0080 ratio
Standard Deviation 0.00458
|
|
Change From Baseline in Clinical Laboratory Measure: Specific Gravity
Change From Baseline at Day 3 (48 hrs)
|
-0.0017 ratio
Standard Deviation 0.00252
|
|
Change From Baseline in Clinical Laboratory Measure: Specific Gravity
Change From Baseline at Day 4 (84 hrs)
|
-0.0015 ratio
Standard Deviation 0.00495
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Vital sign parameters included supine systolic blood pressure (SBP), supine diastolic blood pressure (DBP), standing systolic blood pressure and standing diastolic blood pressure expressed in terms of millimeters of mercury (mmHg). The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4 (84 hrs): Supine DBP
|
7.5 mmHg
Standard Deviation 10.21
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 1 (12 hrs): Supine SBP
|
-2.8 mmHg
Standard Deviation 13.65
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2 (24 hrs): Supine SBP
|
2.3 mmHg
Standard Deviation 11.95
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2 (36 hrs): Supine SBP
|
-1.0 mmHg
Standard Deviation 15.19
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3 (48 hrs): Supine SBP
|
-5.0 mmHg
Standard Deviation 4.40
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3 (60 hrs): Supine SBP
|
12.3 mmHg
Standard Deviation 17.75
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4 (72 hrs): Supine SBP
|
5.0 mmHg
Standard Deviation 23.73
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4 (84 hrs): Supine SBP
|
8.0 mmHg
Standard Deviation 20.69
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 1 (12 hrs): Supine DBP
|
-1.3 mmHg
Standard Deviation 12.50
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2 (24 hrs): Supine DBP
|
3.0 mmHg
Standard Deviation 6.83
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2 (36 hrs): Supine DBP
|
-2.3 mmHg
Standard Deviation 5.68
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3 (48 hrs): Supine DBP
|
-5.0 mmHg
Standard Deviation 5.42
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3 (60 hrs): Supine DBP
|
4.0 mmHg
Standard Deviation 6.22
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4 (72 hrs): Supine DBP
|
0.5 mmHg
Standard Deviation 9.75
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 1(12 hrs):Standing SBP
|
-4.0 mmHg
Standard Deviation 7.87
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2(24 hrs):Standing SBP
|
-1.5 mmHg
Standard Deviation 8.23
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2(36 hrs):Standing SBP
|
-0.8 mmHg
Standard Deviation 7.27
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3(48 hrs):Standing SBP
|
-1.5 mmHg
Standard Deviation 7.68
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3(60 hrs):Standing SBP
|
16.8 mmHg
Standard Deviation 2.50
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4(72 hrs):Standing SBP
|
0.3 mmHg
Standard Deviation 11.53
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4(84 hrs):Standing SBP
|
-0.7 mmHg
Standard Deviation 8.74
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 1(12 hrs):Standing DBP
|
1.0 mmHg
Standard Deviation 8.52
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2(24 hrs):Standing DBP
|
6.3 mmHg
Standard Deviation 4.11
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 2(36 hrs):Standing DBP
|
1.5 mmHg
Standard Deviation 9.11
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3(48 hrs):Standing DBP
|
7.5 mmHg
Standard Deviation 5.92
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 3(60 hrs):Standing DBP
|
13.8 mmHg
Standard Deviation 8.81
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4(72 hrs):Standing DBP
|
13.3 mmHg
Standard Deviation 8.14
|
|
Change From Baseline in Vital Sign: Blood Pressure
Change From Baseline at Day 4(84 hrs):Standing DBP
|
10.3 mmHg
Standard Deviation 3.06
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection.
Vital sign parameter included heart rate expressed in terms of beats per minute (bpm). The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Vital Sign: Heart Rate
Change From Baseline at Day 1 (12 hrs)
|
-2.5 bpm
Standard Deviation 15.35
|
|
Change From Baseline in Vital Sign: Heart Rate
Change From Baseline at Day 2 (24 hrs)
|
5.3 bpm
Standard Deviation 18.84
|
|
Change From Baseline in Vital Sign: Heart Rate
Change From Baseline at Day 2 (36 hrs)
|
-2.3 bpm
Standard Deviation 11.44
|
|
Change From Baseline in Vital Sign: Heart Rate
Change From Baseline at Day 3 (48 hrs)
|
-1.5 bpm
Standard Deviation 11.56
|
|
Change From Baseline in Vital Sign: Heart Rate
Change From Baseline at Day 3 (60 hrs)
|
-3.0 bpm
Standard Deviation 8.41
|
|
Change From Baseline in Vital Sign: Heart Rate
Change From Baseline at Day 4 (72 hrs)
|
-5.8 bpm
Standard Deviation 7.63
|
|
Change From Baseline in Vital Sign: Heart Rate
Change From Baseline at Day 4 (84 hrs)
|
-0.8 bpm
Standard Deviation 4.99
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection.
Vital sign parameter included temperature expressed in terms of degree Celsius. The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Vital Sign: Body Temperature
Change From Baseline at Day 1 (12 hrs)
|
-0.20 degree Celsius
Standard Deviation 0.32
|
|
Change From Baseline in Vital Sign: Body Temperature
Change From Baseline at Day 2 (24 hrs)
|
0.15 degree Celsius
Standard Deviation 0.23
|
|
Change From Baseline in Vital Sign: Body Temperature
Change From Baseline at Day 2 (36 hrs)
|
-0.15 degree Celsius
Standard Deviation 0.33
|
|
Change From Baseline in Vital Sign: Body Temperature
Change From Baseline at Day 3 (48 hrs)
|
-0.05 degree Celsius
Standard Deviation 0.25
|
|
Change From Baseline in Vital Sign: Body Temperature
Change From Baseline at Day 3 (60 hrs)
|
0.03 degree Celsius
Standard Deviation 0.31
|
|
Change From Baseline in Vital Sign: Body Temperature
Change From Baseline at Day 4 (72 hrs)
|
-0.30 degree Celsius
Standard Deviation 0.37
|
|
Change From Baseline in Vital Sign: Body Temperature
Change From Baseline at Day 4 (84 hrs)
|
-0.45 degree Celsius
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
Vital sign parameter included respiratory rate expressed in terms of breaths per minute. The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Vital Sign: Respiratory Rate
Change From Baseline at Day 1 (12 hrs)
|
0.0 breaths/min
Standard Deviation 1.63
|
|
Change From Baseline in Vital Sign: Respiratory Rate
Change From Baseline at Day 2 (24 hrs)
|
0.0 breaths/min
Standard Deviation 2.31
|
|
Change From Baseline in Vital Sign: Respiratory Rate
Change From Baseline at Day 2 (36 hrs)
|
0.0 breaths/min
Standard Deviation 2.31
|
|
Change From Baseline in Vital Sign: Respiratory Rate
Change From Baseline at Day 3 (48 hrs)
|
0.0 breaths/min
Standard Deviation 4.00
|
|
Change From Baseline in Vital Sign: Respiratory Rate
Change From Baseline at Day 3 (60 hrs)
|
0.3 breaths/min
Standard Deviation 1.53
|
|
Change From Baseline in Vital Sign: Respiratory Rate
Change From Baseline at Day 4 (72 hrs)
|
-1.0 breaths/min
Standard Deviation 1.15
|
|
Change From Baseline in Vital Sign: Respiratory Rate
Change From Baseline at Day 4 (84 hrs)
|
-0.5 breaths/min
Standard Deviation 1.00
|
PRIMARY outcome
Timeframe: Baseline, Day 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection.
ECGs parameters included QT interval, PR interval, QTc interval, QRS duration expressed in terms of milliseconds (msec).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration
Change from Baseline at Day 4 (84 hrs):QT Interval
|
-28.5 msec
Standard Deviation 34.31
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration
Change from Baseline at Day 4 (84 hrs):PR Interval
|
-1.0 msec
Standard Deviation 9.87
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration
Change from Baseline at Day 4(84 hrs):QTc Interval
|
13.3 msec
Standard Deviation 10.44
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration
Change from Baseline at Day 4(84 hrs):QRS Duration
|
-3.5 msec
Standard Deviation 7.19
|
PRIMARY outcome
Timeframe: Baseline, Day 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection.
ECGs parameter included heart rate expressed in terms of beats per minute (bpm).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
|
14.3 bpm
Standard Deviation 9.29
|
PRIMARY outcome
Timeframe: At Day 4Population: Safety population included all participants who began infusion with SAGE-547 injection.
Physical examinations included body weight, height, body mass index (BMI) and assessment of body systems (e.g., head, eyes, ears, nose, throat, lungs, abdomen, and extremities) as well as cognitive and mental health examinations (components of the neurological and psychiatric examinations, respectively).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Number of Participants With Physical Examination Findings
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 11Population: Safety population included all participants who began infusion with SAGE-547 injection.
Concomitant medications are other prescription medications, over the counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Number of Participants With Concomitant Medication Usage
|
3 Participants
|
PRIMARY outcome
Timeframe: Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs)Population: Efficacy population included all participants who began infusion with SAGE-547 injection and who completed at least 12 hours of infusion and have efficacy evaluations through the 12-hour visit.
C-SSRS scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicidal ideation and behavior, and a post-baseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, (with score range from 1 to 5, higher score indicates more severity). The data was collected at time-points: Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs).
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Pre-Infusion: Suicidal Ideation
|
3 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-Infusion: Suicidal Ideation
|
0 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Pre-Infusion: Suicidal Behavior
|
1 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Post-Infusion: Suicidal Behavior
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dosePopulation: Pharmacokinetic (PK) population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of SAGE-547
|
97.2 nanograms per millilter (ng/mL)
Standard Deviation 77.3
|
SECONDARY outcome
Timeframe: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dosePopulation: PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.
Tmax is defined as the time at which Cmax of SAGE-547 occurred.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of SAGE-547
|
42 hours
Interval 12.0 to 48.0
|
SECONDARY outcome
Timeframe: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dosePopulation: PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.
AUCall is defined as the area under the plasma SAGE-547 concentration time curves from the start of the infusion until the time the last sample was taken 72 hours later.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Area Under the Concentration-Time Curve From Start of the Infusion Until the Time of the Last Sample (AUCall) of SAGE-547
|
3380 nanograms*hour per milliliter (ng*hr/mL)
Standard Deviation 1410
|
SECONDARY outcome
Timeframe: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, and 60 hrs post-dosePopulation: PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.
AUC0-60 is defined as the area under the plasma SAGE-547 concentration time curve during the intravenous infusion.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to 60 Hours (AUC0-60) of SAGE-547
|
3160 ng*hr/mL
Standard Deviation 1360
|
SECONDARY outcome
Timeframe: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, and 24 hrs post-dosePopulation: PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
AUC24 is defined as the area under the plasma SAGE-547 concentration-time curve in a 24-hour period during the maintenance dose.
Outcome measures
| Measure |
SAGE-547
n=3 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Area Under the Concentration-Time Curve in 24 Hours (AUC24) of SAGE-547
|
1590 ng*hr/mL
Standard Deviation 580
|
SECONDARY outcome
Timeframe: From 12 to 48 hrs (36 hr of maintenance dose period)Population: PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Cavg is defined as the plasma concentration of SAGE-547 at steady-state (average plasma concentration during the maintenance dose period; nominally 12 to 48 hrs).
Outcome measures
| Measure |
SAGE-547
n=3 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Average Drug Concentration in the Plasma at Steady State During a Dosing Interval (Cavg) of SAGE-547
|
66.1 ng/mL
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dosePopulation: PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Plasma Clearance (CL) of SAGE-547
|
1.08 Liters per hour per kilogram (L/hr/kg)
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), Day 3 (at 48 and 60 hrs), and Day 4 (at 84 hrs)Population: Safety population included all participants who began infusion with SAGE-547 injection.
The HAM-D-17 was used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D-17 is comprised of 17 individual items: Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis, where 0 indicated none/absent and higher scores indicated greater depression. The Total Score can range from 0 (least depression) to 52 (greater depression), and higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
Change From Baseline at Day 3 (60 hrs)
|
-24.8 score on a scale
Standard Deviation 4.19
|
|
Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
Change From Baseline at Day 2 (36 hrs)
|
-24.8 score on a scale
Standard Deviation 3.59
|
|
Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
Change From Baseline at Day 3 (48 hrs)
|
-24.3 score on a scale
Standard Deviation 4.99
|
|
Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
Change From Baseline at Day 4 (84 hrs)
|
-21.3 score on a scale
Standard Deviation 6.85
|
|
Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
Change From Baseline at Day 1 (12 hrs)
|
-21.8 score on a scale
Standard Deviation 5.50
|
|
Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
Change From Baseline at Day 2 (24 hrs)
|
-23.3 score on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 84 hrs)Population: Efficacy population included all participants who began infusion with SAGE-547 injection and who completed at least 12 hours of infusion and had efficacy evaluations through the 12-hour visit.
The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I assessment employs a 7-point Likert scale to measure the improvement in the participant's condition. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.
Outcome measures
| Measure |
SAGE-547
n=4 Participants
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Score
Day 1 (12 hrs)
|
1.8 score on a scale
Standard Deviation 0.50
|
|
Clinical Global Impression-Improvement (CGI-I) Score
Day 2 (24 hrs)
|
1.3 score on a scale
Standard Deviation 0.50
|
|
Clinical Global Impression-Improvement (CGI-I) Score
Day 2 (36 hrs)
|
1.0 score on a scale
Standard Deviation 0.00
|
|
Clinical Global Impression-Improvement (CGI-I) Score
Day 3 (48 hrs)
|
1.3 score on a scale
Standard Deviation 0.50
|
|
Clinical Global Impression-Improvement (CGI-I) Score
Day 3 (60 hrs)
|
1.3 score on a scale
Standard Deviation 0.50
|
|
Clinical Global Impression-Improvement (CGI-I) Score
Day 4 (84 hrs)
|
1.5 score on a scale
Standard Deviation 0.58
|
Adverse Events
SAGE-547
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAGE-547
n=4 participants at risk
Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms/kg/hr \[4 hrs\], 43 micrograms/kg/hr \[4 hrs\] and 64.5 micrograms/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 micrograms/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 micrograms/kg/hr \[49 - 52 hrs\], 43 micrograms/kg/hr \[53 - 56 hrs\] and 21.5 micrograms/kg/hr \[57 - 60 hrs\] on Day 3).
|
|---|---|
|
General disorders
Infusion Site Discomfort
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
General disorders
Infusion Site Erythema
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
General disorders
Infusion Site Pain
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
Nervous system disorders
Sedation
|
50.0%
2/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
|
Vascular disorders
Flushing
|
25.0%
1/4 • AEs: Up to Day 11; SAEs: Up to Day 34
Safety population included all participants who began infusion with SAGE-547 injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
- Publication restrictions are in place
Restriction type: OTHER