Trial record 1 of 1 for:
217-PPD-301
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04442503 |
Recruitment Status :
Completed
First Posted : June 22, 2020
Results First Posted : June 22, 2023
Last Update Posted : November 30, 2023
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Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Depression, Postpartum |
Interventions |
Drug: SAGE-217 Drug: Placebo |
Enrollment | 200 |
Participant Flow
Recruitment Details | Participants took part in study at 92 investigational sites in Spain, United Kingdom and United States from 8 June 2020 to 12 April 2022. |
Pre-assignment Details |
Arm/Group Title | Placebo | SAGE-217 50 mg |
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Arm/Group Description | Participants received SAGE-217 matched-placebo capsules, orally, once daily for 14 days. | Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days. |
Period Title: Overall Study | ||
Started | 101 | 99 |
Number of Participants Received Investigational Product (IP) | 98 | 98 |
Completed | 86 | 84 |
Not Completed | 15 | 15 |
Reason Not Completed | ||
Adverse Event | 1 | 1 |
Lost to Follow-up | 8 | 6 |
Physician Decision | 0 | 2 |
Withdrawal by Subject | 3 | 4 |
Reason not Specified | 0 | 1 |
Randomized but not Treated | 3 | 1 |
Baseline Characteristics
Arm/Group Title | Placebo | SAGE-217 50 mg | Total | |
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Arm/Group Description | Participants received SAGE-217 matched-placebo capsules, orally, once daily for 14 days. | Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days. | Total of all reporting groups | |
Overall Number of Baseline Participants | 98 | 98 | 196 | |
Baseline Analysis Population Description |
Safety Set included all participants who were administered Investigational product (IP).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 98 participants | 98 participants | 196 participants | |
31.0 (5.95) | 30.0 (5.90) | 30.5 (5.93) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 98 participants | 98 participants | 196 participants | |
Female |
98 100.0%
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98 100.0%
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196 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 98 participants | 98 participants | 196 participants | |
Hispanic or Latino |
42 42.9%
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33 33.7%
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75 38.3%
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Not Hispanic or Latino |
56 57.1%
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64 65.3%
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120 61.2%
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Unknown or Not Reported |
0 0.0%
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1 1.0%
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1 0.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 98 participants | 98 participants | 196 participants | |
American Indian or Alaska Native |
3 3.1%
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0 0.0%
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3 1.5%
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Asian |
1 1.0%
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1 1.0%
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2 1.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
18 18.4%
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25 25.5%
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43 21.9%
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White |
69 70.4%
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68 69.4%
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137 69.9%
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More than one race |
2 2.0%
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3 3.1%
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5 2.6%
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Unknown or Not Reported |
5 5.1%
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1 1.0%
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6 3.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Name/Title: | US Biogen Clinical Trial Center |
Organization: | Biogen |
Phone: | 866-633-4636 |
EMail: | clinicaltrials@biogen.com |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT04442503 |
Other Study ID Numbers: |
217-PPD-301 2020-001424-34 ( EudraCT Number ) |
First Submitted: | June 18, 2020 |
First Posted: | June 22, 2020 |
Results First Submitted: | April 11, 2023 |
Results First Posted: | June 22, 2023 |
Last Update Posted: | November 30, 2023 |