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Improvements in depressive symptoms (MADRS Score)

5-9
b.Baseline IND phase.
c.Baseline OP/MAINT phase.
d.Number of patients who had a MADRS assessment at a given timepoint of the OP/MAINT phase.
§Remission defined as MADRS total score ≤12.1
IND, induction. MADRS,Montgomery-Asberg Depression Rating Scale. OAD, oral antidepressant. OP/MAINT, optimization/maintenance. SE,standard error.
TRD, Treatment Resistant Depression

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Objective:To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant depression (TRD).

Study Design:This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017.

The study had a 4-week screening phase (direct entry patients only), a 4-week induction (IND) phase (direct-entry patients and transferred-entry non responder patients), an up to 48-week optimization/maintenance (OP/MAINT) phase (all responders from the OL IND phase of the current study and the transferred-entry responders), and a 4-week follow-up phase (for all patients).

802 patients were enrolled. Long-term (up to 1 year) treatment with esketamine nasal spray demonstrated acceptable tolerability and an adverse event profile comparable with that of the short term studies in patients with TRD.

TRD,Treatment-resistant depression
OL,open label
OP/MAINT,optimization/maintenance

Wajs E, Aluisio L, Holder R,et al . Esketamine Nasal Spray Plus Oral
Antidepressant in Patients With Treatment-Resistant Depression:
Assessment of Long-Term Safety in a Phase 3, Open-Label Study
(SUSTAIN-2). J Clin Psychiatry. 2020; 81 (3) :19m12891.

Reference:
1- Wajs E, Aluisio L, Holder R,et al . Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020; 81 (3) :19m12891.


CP-231188