- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02285504
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
January 20, 2022 updated by: Sage Therapeutics
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
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Sage Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Adult females, 18-45 years old who experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery
- Participant has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, participant must agree to cease giving breast milk to their infant prior to study entry
Exclusion Criteria:
- Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders
- Active psychosis
- Medical history of seizures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
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Intravenous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: TEAEs: Up to Day 11, TESAEs: Up to Day 34
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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).
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TEAEs: Up to Day 11, TESAEs: Up to Day 34
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Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measure: Hematocrit
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Clinical Laboratory Measure: Specific Gravity
Time Frame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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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).
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Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
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Change From Baseline in Vital Sign: Blood Pressure
Time Frame: 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)
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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).
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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)
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Change From Baseline in Vital Sign: Heart Rate
Time Frame: 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)
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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).
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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)
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Change From Baseline in Vital Sign: Body Temperature
Time Frame: 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)
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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).
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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)
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Change From Baseline in Vital Sign: Respiratory Rate
Time Frame: 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)
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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).
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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)
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Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration
Time Frame: Baseline, Day 4 (at 84 hrs)
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ECGs parameters included QT interval, PR interval, QTc interval, QRS duration expressed in terms of milliseconds (msec).
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Baseline, Day 4 (at 84 hrs)
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Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
Time Frame: Baseline, Day 4 (at 84 hrs)
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ECGs parameter included heart rate expressed in terms of beats per minute (bpm).
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Baseline, Day 4 (at 84 hrs)
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Number of Participants With Physical Examination Findings
Time Frame: At Day 4
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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).
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At Day 4
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Number of Participants With Concomitant Medication Usage
Time Frame: Baseline up to Day 11
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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.
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Baseline up to Day 11
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Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs)
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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).
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Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax) of SAGE-547
Time Frame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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Time to Maximum Plasma Concentration (Tmax) of SAGE-547
Time Frame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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Tmax is defined as the time at which Cmax of SAGE-547 occurred.
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Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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Area Under the Concentration-Time Curve From Start of the Infusion Until the Time of the Last Sample (AUCall) of SAGE-547
Time Frame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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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.
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Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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Area Under the Concentration-Time Curve From Time Zero to 60 Hours (AUC0-60) of SAGE-547
Time Frame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, and 60 hrs post-dose
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AUC0-60 is defined as the area under the plasma SAGE-547 concentration time curve during the intravenous infusion.
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Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, and 60 hrs post-dose
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Area Under the Concentration-Time Curve in 24 Hours (AUC24) of SAGE-547
Time Frame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, and 24 hrs post-dose
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AUC24 is defined as the area under the plasma SAGE-547 concentration-time curve in a 24-hour period during the maintenance dose.
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Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, and 24 hrs post-dose
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Average Drug Concentration in the Plasma at Steady State During a Dosing Interval (Cavg) of SAGE-547
Time Frame: From 12 to 48 hrs (36 hr of maintenance dose period)
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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).
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From 12 to 48 hrs (36 hr of maintenance dose period)
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Plasma Clearance (CL) of SAGE-547
Time Frame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.
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Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
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Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
Time Frame: 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)
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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.
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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)
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Clinical Global Impression-Improvement (CGI-I) Score
Time Frame: 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)
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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.
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Stephen J Kanes, MD, PhD, Sage Therapeutics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2015
Primary Completion (Actual)
June 5, 2015
Study Completion (Actual)
June 5, 2015
Study Registration Dates
First Submitted
October 22, 2014
First Submitted That Met QC Criteria
November 4, 2014
First Posted (Estimate)
November 7, 2014
Study Record Updates
Last Update Posted (Actual)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- Depression, Postpartum
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- GABA Modulators
- GABA Agents
- Neurosteroids
- Brexanolone
Other Study ID Numbers
- 547-PPD-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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