Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614547
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : September 13, 2021
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Postpartum Depression Drug: SAGE-547 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : June 22, 2016
Actual Study Completion Date : June 22, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Brexanolone

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received infusion rates of placebo matched to SAGE-547.
Drug: Placebo
Administered as intravenous infusion.

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).
Drug: SAGE-547
Administered as intravenous infusion.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of Participants With HAM-D Response [ Time Frame: 60 Hours, Days 7 and 30 ]
    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.

  2. Percentage of Participants With HAM-D Remission [ Time Frame: 60 Hours, Days 7, and 30 ]
    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.

  3. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline, 60 Hours, Days 7 and 30 ]
    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.

  4. Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response [ Time Frame: 60 Hours, Days 7 and 30 ]
    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".

  5. Change From Baseline in HAM-D Bech 6 Subscale [ Time Frame: Baseline, 60 Hours, Days 7 and 30 ]
    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.

  6. Change From Baseline to 60 Hours in the HAM-D Individual Item Scores [ Time Frame: Baseline, 60 Hours ]
    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.

  7. Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score [ Time Frame: Baseline, 60 Hours, Day 7 and 30 ]
    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.

  8. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614547


Locations
Layout table for location information
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30342
United States, Massachusetts
Sage Investigational Site
Worcester, Massachusetts, United States, 01655
United States, North Carolina
Sage Investigational Site
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Sage Therapeutics
Investigators
Layout table for investigator information
Study Chair: Stephen J Kanes, MD, PhD Sage Therapeutics
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02614547    
Other Study ID Numbers: 547-PPD-202 A
First Posted: November 25, 2015    Key Record Dates
Results First Posted: September 13, 2021
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Brexanolone
Neurosteroids
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Modulators
GABA Agents