Clinical trial NCT02614547: A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Postpartum Depression
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.


Eligibility criteria: Key Inclusion Criteria:

* Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
* 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 was less than or equal to (\<=) six months postpartum.
* Participant must be amenable to intravenous therapy.

Key Exclusion Criteria:

* Active psychosis.
* Attempted suicide associated with index case of postpartum depression.
* Medical history of seizures.
* Medical history of bipolar disorder.

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

Primary outcomes:
measure: Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score
timeFrame: Baseline, 60 Hours
Secondary outcomes:
measure: Percentage of Participants With HAM-D Response
timeFrame: 60 Hours, Days 7 and 30
measure: Percentage of Participants With HAM-D Remission
timeFrame: 60 Hours, Days 7, and 30
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline, 60 Hours, Days 7 and 30
measure: Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response
timeFrame: 60 Hours, Days 7 and 30
measure: Change From Baseline in HAM-D Bech 6 Subscale
timeFrame: Baseline, 60 Hours, Days 7 and 30
measure: Change From Baseline to 60 Hours in the HAM-D Individual Item Scores
timeFrame: Baseline, 60 Hours
measure: Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score
timeFrame: Baseline, 60 Hours, Day 7 and 30
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Worcester
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Chapel Hill
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Sage Investigational Site
state: Pennsylvania
Study officials:
affiliation: Sage Therapeutics
name: Stephen J Kanes, MD, PhD
role: STUDY_CHAIR
References:
citation: Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12.
citation: Kanes S, Colquhoun H, Gunduz-Bruce H, Raines S, Arnold R, Schacterle A, Doherty J, Epperson CN, Deligiannidis KM, Riesenberg R, Hoffmann E, Rubinow D, Jonas J, Paul S, Meltzer-Brody S. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. Lancet. 2017 Jul 29;390(10093):480-489. doi: 10.1016/S0140-6736(17)31264-3. Epub 2017 Jun 12.