Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442503
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Drug: SAGE-217 Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-217
Participants will receive SAGE-217 capsules, once daily for 14 days.
Drug: SAGE-217
SAGE-217 oral capsules.

Placebo Comparator: Placebo
Participants will receive SAGE-217 matched-placebo capsules, once daily for 14 days.
Drug: Placebo
SAGE-217 matched-placebo oral capsules.




Primary Outcome Measures :
  1. Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 [ Time Frame: Baseline and Day 15 ]
    The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.


Secondary Outcome Measures :
  1. Change From Baseline in the 17-item HAM-D Total Score [ Time Frame: Baseline and Days 3, 28 and 45 ]
    The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.

  2. Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score [ Time Frame: Baseline and Day 15 ]
    The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A participant is assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants.

  3. Percentage of Participants With HAM-D Response [ Time Frame: Baseline and Days 15 and 45 ]
    HAM-D response is defined as a ≥50% reduction in HAM-D score from baseline.

  4. Percentage of Participants With HAM-D Remission [ Time Frame: Days 15 and 45 ]
    HAM-D remission is defined as HAM-D total score ≤7.

  5. Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response [ Time Frame: Day 15 ]
    CGI-I response is defined as having a CGI-I score of "very much improved" or "much improved." The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. Response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.

  6. Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Baseline and Day 15 ]
    The 14-item HAM-A is comprised of a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score will be calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56.

  7. Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and Day 15 ]
    The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. Each item is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression.

  8. Change From Baseline in HAM-D Subscale [ Time Frame: Baseline and Day 15 ]
    The 17-item HAM-D is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D subscale scores will be calculated as the sum of the items comprising each subscale. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe.

  9. Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score [ Time Frame: Baseline and up to Day 45 ]
    The EPDS is a self-rated depressive symptom severity scale specific to the perinatal period which consists of 10 individual items. Each item is rated on a 4-point scale ranging from 0 to 3 points. The EPDS total score is calculated as the sum of the 10 individual item scores, ranging from 0 points to 30 points with a higher score indicating more depression.

  10. Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score [ Time Frame: Baseline and up to Day 45 ]
    The PHQ-9 is a participant-rated depressive symptom severity scale where scoring is based on responses to specific questions. The score will be calculated as the sum of the 9 individual item scores. The PHQ-9 total score ranges from 1 to 27 with a higher score indicating more depression.

  11. Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Up to Day 45 ]


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
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
  • Participant has 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 Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
  • Participant is ≤6 months postpartum.

Exclusion Criteria:

  • Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
  • Participant has active psychosis per investigator assessment.
  • Participant has a medical history of nonfebrile seizures.
  • Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  • Participant has a history of sleep apnea.

Note: Other protocol-defined inclusion/exclusion criteria applied.


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): NCT04442503


Contacts
Layout table for location contacts
Contact: Handan Gunduz-Bruce +1 617 949 2883 handan.gunduz-bruce@sagerx.com

Locations
Show Show 47 study locations
Sponsors and Collaborators
Sage Therapeutics
Layout table for additonal information
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT04442503    
Other Study ID Numbers: 217-PPD-301
2020-001424-34 ( EudraCT Number )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sage Therapeutics:
SAGE-217
Postpartum depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications