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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02942017




Registration number
NCT02942017
Ethics application status
Date submitted
20/10/2016
Date registered
21/10/2016

Titles & IDs
Public title
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
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 C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Placebo
Treatment: Drugs - SAGE-547 90 µg/kg/h

Placebo comparator: Placebo - Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (µg/kg/h) group.

Experimental: SAGE-547 90 µg/kg/h - Participants received a 4-hour dose titration period of 30 µg/kg/h (0 to 4 hours), then 60 µg/kg/h (4 to 24 hours), then 90 µg/kg/h (24 to 52 hours), followed by a taper to 60 µg/kg/h (52 to 56 hours), and 30 µg/kg/h (56 to 60 hours).


Treatment: Drugs: Placebo
Intravenous infusion of matching placebo for SAGE-547.

Treatment: Drugs: SAGE-547 90 µg/kg/h
Intravenous infusion of SAGE-547
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score
Timepoint [1] 0 0
Baseline, Hour 60
Secondary outcome [1] 0 0
Change From Baseline in HAM-D Total Score at Day 30
Timepoint [1] 0 0
Baseline, Day 30
Secondary outcome [2] 0 0
Change From Baseline in HAM-D Total Score
Timepoint [2] 0 0
Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21
Secondary outcome [3] 0 0
Percentage of Participants With HAM-D Response
Timepoint [3] 0 0
Hour 60, Days 7 and 30
Secondary outcome [4] 0 0
Percentage of Participants With HAM-D Remission
Timepoint [4] 0 0
Hour 60, Days 7 and 30
Secondary outcome [5] 0 0
Change From Baseline in HAM-D Bech 6 Subscale
Timepoint [5] 0 0
Baseline, Hour 60, Days 7 and 30
Secondary outcome [6] 0 0
Change From Baseline in HAM-D Individual Item Scores
Timepoint [6] 0 0
Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30
Secondary outcome [7] 0 0
Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Timepoint [7] 0 0
Baseline, Hour 60, Days 7 and 30
Secondary outcome [8] 0 0
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
Timepoint [8] 0 0
Hour 60, Days 7 and 30
Secondary outcome [9] 0 0
Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
Timepoint [9] 0 0
Baseline, Hour 60, Days 7, 14, 21 and 30
Secondary outcome [10] 0 0
Percentage of Participants With Treatment Emergent Adverse Event (TEAE)
Timepoint [10] 0 0
Up to approximately 37 days
Secondary outcome [11] 0 0
Time to Change in Antidepressant Medication
Timepoint [11] 0 0
Up to approximately 37 days

Eligibility
Key inclusion criteria
Key

* Participant either must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s).
* 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 had a HAM-D total score of =20 and =25 at screening and Day 1 (prior to dosing).
* Participant was = six months postpartum.
* Participant was amenable to intravenous therapy.

Key
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active psychosis.
* Attempted suicide associated with index case of postpartum depression.
* Medical history of bipolar disorder.

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

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
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/10/2017
Sample size
Target
Accrual to date
Final
108
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
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02942017