An Open-Label Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-547 Injection in the Treatment of Adult Female Patients With Severe Postpartum Depression

Change From Baseline in Clinical Laboratory Measure: Hematocrit

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Vital Sign: Heart Rate

时间窗: 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)

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).

Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

时间窗: TEAEs: Up to Day 11, TESAEs: Up to Day 34

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).

Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Vital Sign: Blood Pressure

时间窗: 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)

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).

Change From Baseline in Vital Sign: Body Temperature

时间窗: 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)

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).

Number of Participants With Physical Examination Findings

时间窗: At Day 4

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).

Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

时间窗: Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs)

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).

Change From Baseline in Clinical Laboratory Measure: Specific Gravity

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).

Change From Baseline in Vital Sign: Respiratory Rate

时间窗: 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)

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).

Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration

时间窗: Baseline, Day 4 (at 84 hrs)

ECGs parameters included QT interval, PR interval, QTc interval, QRS duration expressed in terms of milliseconds (msec).

Number of Participants With Concomitant Medication Usage

时间窗: Baseline up to Day 11

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.

Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate

时间窗: Baseline, Day 4 (at 84 hrs)

ECGs parameter included heart rate expressed in terms of beats per minute (bpm).

Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)

时间窗: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)

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).