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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02942004




Registration number
NCT02942004
Ethics application status
Date submitted
20/10/2016
Date registered
21/10/2016
Date last updated
10/09/2018

Titles & IDs
Public title
A Study to Evaluate SAGE-547 in Patients With Severe Postpartum Depression
Scientific 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 and Adult Female Subjects With Moderate Postpartum Depression
Secondary ID [1] 0 0
547-PPD-202 B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Postpartum Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAGE-547
Treatment: Drugs - Placebo

Experimental: SAGE-547 Standard Dose - Intravenous

Experimental: SAGE-547 Lower Dose - Intravenous

Placebo Comparator: Placebo - Intravenous


Treatment: Drugs: SAGE-547


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect of SAGE-547 on depressive symptoms in subjects with severe postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score
Timepoint [1] 0 0
3 Days
Secondary outcome [1] 0 0
Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters
Timepoint [1] 0 0
30 Days
Secondary outcome [2] 0 0
Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score
Timepoint [2] 0 0
30 Days

Eligibility
Key inclusion criteria
Key

- Subject either must have ceased lactating at Screening; or if still lactating or
actively breastfeeding at Screening, must agree to temporarily cease giving breastmilk
to their infant(s).

- Subject 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 DSM-IV Axis I Disorders (SCID-I)

- Subject is = six months postpartum

- Subject must be amenable to IV therapy

Key
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active psychosis

- Attempted suicide associated with index case of postpartum depression

- Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.

Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion
criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
New Zealand
State/province [22] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sage Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
the efficacy, safety, and pharmacokinetics of two dose levels of SAGE-547 Injection in up to
120 adult female subjects diagnosed with severe postpartum depression
Trial website
https://clinicaltrials.gov/show/NCT02942004
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helen Colquhoun, MD
Address 0 0
Sage Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications