- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02614547
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
January 20, 2022 updated by: Sage Therapeutics
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating The Efficacy, Safety, And Pharmacokinetics Of SAGE-547 Injection In The Treatment Of Adult Female Subjects With Severe Postpartum Depression
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
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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Georgia
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Atlanta, Georgia, United States, 30342
- Sage Investigational Site
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- Sage Investigational Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Sage Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- 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
Key Inclusion Criteria:
- Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
- Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
- Participant was less than or equal to (<=) six months postpartum.
- Participant must be amenable to intravenous therapy.
Key Exclusion Criteria:
- Active psychosis.
- Attempted suicide associated with index case of postpartum depression.
- Medical history of seizures.
- Medical history of bipolar disorder.
Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Participants received infusion rates of placebo matched to SAGE-547.
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Administered as intravenous infusion.
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Experimental: SAGE-547
Participants received a 4-hour dose titration of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
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Administered as intravenous infusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score
Time Frame: Baseline, 60 Hours
|
The HAM-D total score comprises a sum of the 17 individual item scores.
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.
The total score can range from 0 to 52, 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, 60 Hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With HAM-D Response
Time Frame: 60 Hours, Days 7 and 30
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The HAM-D response was defined as having a 50 percent (%) or greater reduction from baseline in HAM-D total score.
The HAM-D total score comprises a sum of the 17 individual item scores.
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.
The total score can range from 0 to 52, 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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60 Hours, Days 7 and 30
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Percentage of Participants With HAM-D Remission
Time Frame: 60 Hours, Days 7, and 30
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The HAM-D remission was defined as having a HAM-D total score of less than or equal to (<=)7.
The HAM-D total score comprises a sum of the 17 individual item scores.
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.
The total score can range from 0 to 52, 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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60 Hours, Days 7, and 30
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline, 60 Hours, Days 7 and 30
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The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders.
It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment.
Each item yielded a score of 0 to 6.
The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicate more severe depression.
A negative change from baseline indicate less severe depression.
A positive change from baseline indicates more severe depression.
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Baseline, 60 Hours, Days 7 and 30
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Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response
Time Frame: 60 Hours, Days 7 and 30
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The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment.
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, and by definition, was evaluated against baseline conditions.
CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved".
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60 Hours, Days 7 and 30
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Change From Baseline in HAM-D Bech 6 Subscale
Time Frame: Baseline, 60 Hours, Days 7 and 30
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The HAM-D Bech 6 subscale score was calculated as the sum of the following six items: depressed mood, feelings of guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms.
Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression.
The scores were transformed to a scale of 0 to 100, with a higher score indicating 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, 60 Hours, Days 7 and 30
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Change From Baseline to 60 Hours in the HAM-D Individual Item Scores
Time Frame: Baseline, 60 Hours
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The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight.
The following symptoms 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.
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, 60 Hours
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Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score
Time Frame: Baseline, 60 Hours, Day 7 and 30
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The GAD-7 is a participant-rated, generalized anxiety symptom severity scale.
Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = "not at all sure," 1 = "several days," 2 = "over half the days," and 3 = "nearly every day" to the response categories.
The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety.
The GAD-7 total score was calculated as the sum of the seven individual item scores.
A negative change from baseline indicates less anxiety.
A positive change from baseline indicates more anxiety.
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Baseline, 60 Hours, Day 7 and 30
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 30 days
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An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
A TEAE was defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
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Up to 30 days
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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.
General Publications
- Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12.
- Kanes S, Colquhoun H, Gunduz-Bruce H, Raines S, Arnold R, Schacterle A, Doherty J, Epperson CN, Deligiannidis KM, Riesenberg R, Hoffmann E, Rubinow D, Jonas J, Paul S, Meltzer-Brody S. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. Lancet. 2017 Jul 29;390(10093):480-489. doi: 10.1016/S0140-6736(17)31264-3. Epub 2017 Jun 12.
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)
December 15, 2015
Primary Completion (Actual)
June 22, 2016
Study Completion (Actual)
June 22, 2016
Study Registration Dates
First Submitted
November 2, 2015
First Submitted That Met QC Criteria
November 23, 2015
First Posted (Estimate)
November 25, 2015
Study Record Updates
Last Update Posted (Actual)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
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-202 A
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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