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A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

NCT ID: NCT02978326

Last Updated: 2023-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-04

Study Completion Date

2018-12-11

Brief Summary

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The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Detailed Description

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

Conditions

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Postpartum Depression

Keywords

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Postpartum Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: SAGE-217 15/20 mg Oral Solution

Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.

Group Type EXPERIMENTAL

SAGE-217 15/20 mg Oral Solution

Intervention Type DRUG

SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).

Part B: Placebo

Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.

Part B: SAGE 217 30 mg Capsules

Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.

Group Type EXPERIMENTAL

SAGE 217 30 mg Capsules

Intervention Type DRUG

SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.

Interventions

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SAGE-217 15/20 mg Oral Solution

SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).

Intervention Type DRUG

Placebo

SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.

Intervention Type DRUG

SAGE 217 30 mg Capsules

SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)
* 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 the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)
* Participant was \<=six months postpartum.

Exclusion Criteria

* Active psychosis
* Attempted suicide associated with current episode of postpartum depression
* Medical history of seizures
* Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

Little Rock, Arkansas, United States

Site Status

Sage Investigational Site

Beverly Hills, California, United States

Site Status

Sage Investigational Site

Oceanside, California, United States

Site Status

Sage Investigational Site

Wildomar, California, United States

Site Status

Sage Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Sage Investigational Site

Aventura, Florida, United States

Site Status

Sage Investigational Site

Miami, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Pensacola, Florida, United States

Site Status

Sage Investigational SIte

Pinellas Park, Florida, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Hoffman Estates, Illinois, United States

Site Status

Sage Investigational Site

Owensboro, Kentucky, United States

Site Status

Sage Investigational Site

Lake Charles, Louisiana, United States

Site Status

Sage Investigational Site

New Orleans, Louisiana, United States

Site Status

Sage Investigational Site

Saint Charles, Missouri, United States

Site Status

Sage Investigational Site

Las Vegas, Nevada, United States

Site Status

Sage Investigational Site

Manhasset, New York, United States

Site Status

Sage Investigational Site

New York, New York, United States

Site Status

Sage Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Sage Investigational Site

Raleigh, North Carolina, United States

Site Status

Sage Investigational Site

Providence, Rhode Island, United States

Site Status

Sage Investigational Site

Fort Worth, Texas, United States

Site Status

Sage Investigational Site

Houston, Texas, United States

Site Status

Sage Investigational Site

Richardson, Texas, United States

Site Status

Sage Investigational Site

Orem, Utah, United States

Site Status

Countries

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United States

References

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Deligiannidis K, Lasser R, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Assessment of Depressive Symptoms Across Multiple Measures. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.

Reference Type RESULT

Lasser R, Deligiannidis K, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Topline Assessment of Secondary Efficacy Measures of Anxiety and Depression. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.

Reference Type RESULT

Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559.

Reference Type RESULT
PMID: 34190962 (View on PubMed)

Deligiannidis KM, Citrome L, Huang MY, Acaster S, Fridman M, Bonthapally V, Lasser R, Kanes SJ. Effect of Zuranolone on Concurrent Anxiety and Insomnia Symptoms in Women With Postpartum Depression. J Clin Psychiatry. 2023 Jan 30;84(1):22m14475. doi: 10.4088/JCP.22m14475.

Reference Type DERIVED
PMID: 36724109 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.sagerx.com

Related Info

Other Identifiers

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217-PPD-201

Identifier Type: -

Identifier Source: org_study_id