Efficacy

Time course of response and efficacy of SPRAVATO® (esketamine) in adult patients with TRD at 4 weeks

Actor portrayal.

TRD=treatment-resistant depression in adults.

MDSI=depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

SPRAVATO® (esketamine) + oral AD demonstrated rapid and superior improvement in depressive symptoms at Week 4 compared to placebo + oral AD for adults with TRD1,2

TRD Primary Short-term Chart
  • Most of the treatment difference between SPRAVATO® and placebo was observed at 24 hours
  • Between 24 hours and Day 28, both SPRAVATO® and placebo groups continued to improve, and the difference between these 2 groups generally remained the same

AD=antidepressant.

LS=least squares.

MADRS=Montgomery-Åsberg Depression Rating Scale.

Click here to see short-term safety data

TRD Study 1 (Short-term) Study Design1,2

Evaluated in a randomized, placebo-controlled, double-blind, short-term (4-week) study in adults with TRD; all patients in the trial received a new oral AD. Primary endpoint was change from baseline in the MADRS total score at 4 weeks.1,2

Demonstrated rapid and superior improvement in depressive symptoms at Week 4 for adults with TRD1,2

TRD Study 1 Short-term Design

Primary Endpoint

  • Change from baseline (Day 1) to endpoint (Day 28) in Montgomery-Åsberg Depression Rating Scale (MADRS) score

Flexible Dosing

  • Patients (aged 18-64 years) were randomized to receive twice-weekly doses of SPRAVATO® (flexible dose; 56 mg or 84 mg) plus a newly initiated oral AD or intranasal placebo plus newly initiated oral AD
  • Dosages could be titrated to 84 mg or maintained on 56 mg, and were adjusted on Day 4, 8, 11, or 15
  • Dosages remained stable after Day 15

Oral Antidepressant

  • A newly initiated open-label oral AD (SSRIs: escitalopram, sertraline; SNRIs: duloxetine, venlafaxine extended-release) was initiated on Day 1
  • The selection of the newly initiated oral AD was determined by the investigator based on patient’s prior history

Demographics and Baseline Characteristics

  • Median age 47 years; 62% female; 93% Caucasian; 5% Black

Secondary descriptive endpoints: TRD response and remission rates at Week 41,2

TRD Secondary Short-term Chart
  • Response was defined as an improvement of at least 50% from baseline in total MADRS score
  • Remission was defined as a MADRS total score of ≤12
  • All subjects taking SPRAVATO® started on 56 mg on Day 1. Dose adjustment was made on prespecified days based on clinical judgment
callout-background

Next: Safety and tolerability

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References:

1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

2. Popova V, Daly EJ, Trivedi M, et al. Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study [published online May 21, 2019]. Am J Psychiatry. 2019;176(6):428-438. doi: 10.1176/appi.ajp.2019.19020172