Clinical trial NCT02285504: Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Depression
Keywords: Postpartum depression
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-11-07
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: TEAEs: Up to Day 11, TESAEs: Up to Day 34
measure: Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measure: Hematocrit
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Clinical Laboratory Measure: Specific Gravity
timeFrame: Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)
measure: Change From Baseline in Vital Sign: Blood Pressure
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)
measure: Change From Baseline in Vital Sign: Heart Rate
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)
measure: Change From Baseline in Vital Sign: Body Temperature
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)
measure: Change From Baseline in Vital Sign: Respiratory Rate
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)
measure: Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration
timeFrame: Baseline, Day 4 (at 84 hrs)
measure: Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
timeFrame: Baseline, Day 4 (at 84 hrs)
measure: Number of Participants With Physical Examination Findings
timeFrame: At Day 4
measure: Number of Participants With Concomitant Medication Usage
timeFrame: Baseline up to Day 11
measure: Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs)
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of SAGE-547
timeFrame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
measure: Time to Maximum Plasma Concentration (Tmax) of SAGE-547
timeFrame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
measure: Area Under the Concentration-Time Curve From Start of the Infusion Until the Time of the Last Sample (AUCall) of SAGE-547
timeFrame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
measure: Area Under the Concentration-Time Curve From Time Zero to 60 Hours (AUC0-60) of SAGE-547
timeFrame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, and 60 hrs post-dose
measure: Area Under the Concentration-Time Curve in 24 Hours (AUC24) of SAGE-547
timeFrame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, and 24 hrs post-dose
measure: Average Drug Concentration in the Plasma at Steady State During a Dosing Interval (Cavg) of SAGE-547
timeFrame: From 12 to 48 hrs (36 hr of maintenance dose period)
measure: Plasma Clearance (CL) of SAGE-547
timeFrame: Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose
measure: Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score
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)
measure: Clinical Global Impression-Improvement (CGI-I) Score
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)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Sage Investigational Site
state: North Carolina
Study officials:
affiliation: Sage Therapeutics
name: Stephen J Kanes, MD, PhD
role: STUDY_CHAIR
References: