Clinical Trials

Our team is committed to developing new medicines to treat rare, life-threatening central nervous system (CNS) disorders. An important piece of that development includes our clinical trials.

Postpartum Depression

PPD-202 Trials

Evaluating a new therapeutic candidate for postpartum depression (PPD)

The PPD-202 Trial is comprised of three (one completed and two ongoing) multi-center, randomized, double-blind, parallel-group, placebo-controlled studies evaluating the efficacy, safety and pharmacokinetics of SAGE-547 Injection in the treatment of adult female subjects with moderate to severe postpartum depression. Following top-line results in July 2016 from PPD-202A in women with severe PPD, Sage initiated an expansion of the clinical program with two randomized, placebo-controlled clinical trials to explore dose-ranging of SAGE-547 in severe PPD patients and to evaluate SAGE-547 efficacy in moderate PPD patients.

Additional Information

For more information about this trial and contact info for participating locations, please visit

Any travel required to participate in this trial will be coordinated and paid for by Sage Therapeutics. For more information, please speak with the study coordinator at a participating clinical trial site.

We are committed to respecting the primary role of healthcare providers in the treatment of CNS disorders. Therefore, we cannot respond to medical questions about your personal health situation, nor can we accept private medical information. Please contact your healthcare provider with any questions pertaining to your or a family member's medical condition.

Status Epilepticus

STATUS Trial

Evaluating a new therapeutic option for super-refractory status epilepticus (SRSE)

The STATUS Trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAGE-547 Injection in the treatment of patients with super-refractory status epilepticus (SRSE).

Inclusion Criteria

Patients 2 years of age or older who present with status epilepticus and meet all of the following criteria:

  • First-line:
    • Failure to respond to at least one first-line agent, such as a benzodiazepine or other initial anti-epileptic drug (AED)
  • Second-line:
    • Failure to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam, or other continuous IV [cIV] AED)
  • Third-line (one of the following):
    • No previous administration of a third-line agent, but patient is admitted to the ICU with the intent of administering at least one third-line agent for at least 24 hours
    • Previous failure of one or more wean attempts from third-line agent, and patient is now on cIV infusions of one or more third-line agents and is in an EEG burst suppression pattern
    • Previous failure of one or more wean attempts from third-line agents and patient is not in an EEG burst suppression pattern with or without a cIV infusion of at least one third-line agent

Expanded Access

In addition to the Phase 3 STATUS Trial, an open-label, expanded access study has been initiated. This study is designed to offer SAGE-547 to patients with SRSE and to evaluate the efficacy and safety of SAGE-547.

If you are a physician or institution with an SRSE patient to assess for eligibility, please visit the STATUS Trial website for more information.     

Additional Information

For more information about this trial and participating locations, please visit the STATUS Trial website.

We are committed to respecting the primary role of healthcare providers in the treatment of CNS disorders. Therefore, we cannot respond to medical questions about your personal health situation, nor can we accept private medical information. Please contact your healthcare provider with any questions pertaining to your or a family member's medical condition