Clinical trial NCT03000530: A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder
Official title: A Phase 2, Two-Part (Open-Label Followed by Double-Blind) Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Adult Subjects With Moderate to Severe Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depression
Keywords: Depression
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.

Detailed description: Part A of the study is an open-label design with dosing of SAGE-217 for 14 days.

Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to SAGE-217 or placebo for 14 days.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

* Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion Criteria:

* Participant has a history of suicide attempt
* Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
* Participant has active psychosis
* Participant has a medical history of seizures
* Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A
timeFrame: Day 1 up to Day 21
measure: Percentage of Participants With TEAEs, Graded by Severity - Part A
timeFrame: Day 1 up to Day 21
measure: Change From Baseline in Basophils - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Eosinophils - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Hematocrit - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Hemoglobin - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Lymphocytes - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Monocytes - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Neutrophils - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Platelets - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Erythrocytes - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Reticulocytes - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Leukocytes - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Albumin - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Alkaline Phosphatase - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Alanine Aminotransferase - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Aspartate Aminotransferase - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Bilirubin - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Chloride - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Carbon Dioxide - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Creatinine - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Potassium - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Protein - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Sodium - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Urea Nitrogen - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Activated Partial Thromboplastin Time - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Prothrombin Time - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in pH - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline in Specific Gravity - Part A
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Heart Rate - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Respiratory Rate - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Oral Temperature - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
measure: Change From Baseline (CFB) in Oxygen Saturation - Part A
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose)
measure: Change From Baseline in QT Interval - Part A
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in QTcF Interval - Part A
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in ECG Mean Heart Rate - Part A
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in RR Interval - Part A
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in PR Interval - Part A
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in QRS Interval - Part A
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item - Part A
timeFrame: Day 1 up to Day 28
measure: Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 15 - Part A
timeFrame: Baseline, Day 15
measure: Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 - Part B
timeFrame: Baseline, Day 15
Secondary outcomes:
measure: Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
measure: Percentage of Participants With TEAEs - Part B
timeFrame: Day 1 up to Day 21
measure: Percentage of Participants With AEs During Post-TEAE Period
timeFrame: Day 21 up to Day 42
measure: Percentage of Participants With TEAEs, Graded by Severity - Part B
timeFrame: Day 1 up to Day 21
measure: Change From Baseline in Basophils - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Eosinophils - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Hematocrit - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Hemoglobin - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Lymphocytes - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Monocytes - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Neutrophils - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Platelets - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Erythrocytes - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Reticulocytes - Part B
timeFrame: Baseline, Day 8, Day 15/ET
measure: Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Leukocytes - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Albumin - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Alkaline Phosphatase - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Alanine Aminotransferase - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Aspartate Aminotransferase - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Bilirubin - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Calcium - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Chloride - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Carbon Dioxide - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Creatinine - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Glucose - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Potassium - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Magnesium - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Phosphate - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Protein - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Sodium - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Thyrotropin - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Urea Nitrogen - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Activated Partial Thromboplastin Time - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Prothrombin Time - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in pH - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline in Specific Gravity - Part B
timeFrame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Heart Rate - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Respiratory Rate - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Oral Temperature - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
measure: Change From Baseline (CFB) in Oxygen Saturation - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose)
measure: Change From Baseline in QT Interval - Part B
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in QTcF Interval - Part B
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in ECG Mean Heart Rate - Part B
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in RR Interval - Part B
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in PR Interval - Part B
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Change From Baseline in QRS Duration - Part B
timeFrame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
measure: Percentage of Participants With a Response of "Yes" to Any C-SSRS Suicidal Ideation (SI) Item - Part B
timeFrame: Screening, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 21, 28, 35 and 42
measure: Percentage of Participants With HAM-D Response - Part A
timeFrame: Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
measure: Percentage of Participants With HAM-D Remission - Part A
timeFrame: Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
measure: Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
measure: Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
measure: Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A
timeFrame: Baseline, Days 2, 3, 8, 15, 21 and 28
measure: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A
timeFrame: Days 2, 3, 8, 15, 21 and 28
measure: Change From Baseline (CFB) in the SSS Score - Part B
timeFrame: Baseline, Day 1 (0.25, 0.5, 1, 2 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15
measure: Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42
measure: Percentage of Participants With HAM-D Response - Part B
timeFrame: Days 2, 8, 15, 21, 28, 35 and 42
measure: Percentage of Participants With HAM-D Remission - Part B
timeFrame: Days 2, 8, 15, 21, 28, 35 and 42
measure: Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B
timeFrame: Baseline, Days 2, 8, 15, 21, 28, 35 and 42
measure: Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42
measure: Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42
measure: Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B
timeFrame: Baseline, Days 2, 8, 15, 21, 28, 35 and 42
measure: Percentage of Participants With CGI-I Response - Part B
timeFrame: Days 2, 8, 15, 21, 28, 35 and 42
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Sage Investigational Site
state: California
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Lake Charles
country: United States
facility: Sage Investigational Site
state: Louisiana
city: Berlin
country: United States
facility: Sage Investigational Site
state: New Jersey
city: Dayton
country: United States
facility: Sage Investigational Site
state: Ohio
city: Austin
country: United States
facility: Sage Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Sage Investigational Site
state: Virginia
Study officials:
References:
citation: Gunduz-Bruce H, Silber C, Kaul I, Rothschild AJ, Riesenberg R, Sankoh AJ, Li H, Lasser R, Zorumski CF, Rubinow DR, Paul SM, Jonas J, Doherty JJ, Kanes SJ. Trial of SAGE-217 in Patients with Major Depressive Disorder. N Engl J Med. 2019 Sep 5;381(10):903-911. doi: 10.1056/NEJMoa1815981.
citation: Suthoff E, Kosinski M, Arnaud A, Hodgkins P, Gunduz-Bruce H, Lasser R, Silber C, Sankoh AJ, Li H, Werneburg B, Jonas J, Doherty J, Kanes SJ, Bonthapally V. Patient-reported health-related quality of life from a randomized, placebo-controlled phase 2 trial of zuranolone in adults with major depressive disorder. J Affect Disord. 2022 Jul 1;308:19-26. doi: 10.1016/j.jad.2022.03.068. Epub 2022 Apr 2.