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Psych Congress  

Withdrawal Symptom Assessment in an Esketamine Safety Study in Patients With Treatment-Resistant Depression in SUSTAIN-2 (NCT02497287)

Authors  

Lynn Yieh, PhD – Janssen R&D; Leah Aluisio, PhD – Janssen R&D; Ewa Wajs, MD, PhD – Janssen R&D; Allitia Di Bernardo, MD – Janssen R&D; Andrew Krystal, MD – University of California at San Francisco; Wayne Drevets, MD – Janssen R&D; Yun Wu, PhD – Janssen R&D; Jagadish Gogate, PhD – Janssen R&D; Ella Daly, MD – Janssen R&D; Peter Zannikos, PhD – Janssen R&D; Valerie Curran, PhD – University College London; Guang Chen, MD, PhD – Janssen R&D; Jaskaran Singh, MD – Janssen R&D

Sponsor  
Janssen Research and Development

We assessed potential withdrawal symptoms in patients with treatment-resistant depression (TRD) after long-term, intermittent use of intranasal esketamine (ESK). Patients received ESK 2X/week and a newly initiated oral antidepressant (AD) during a 4-week induction phase (IND). Responders who entered the optimization/maintenance phase (OP/MA) received ESK weekly or every two weeks + AD for ≥ 48 weeks. Physician Withdrawal Checklist (PWC-20) assessments occurred at the last ESK dosing and at weeks 1, 2 and 4 of follow up (F/U), using a 0-3-point scale (Not present = 0 to Severe = 3). Depression symptoms (PWC-DS; common to PWC-20 and depression rating scales), and withdrawal symptoms (PWC-WS; specific to PWC-20) were analyzed for 357 patients. Mean (SD) PWC-20 total scores (range 0-60) at treatment endpoint, Week 1, 2 and 4 were 7.2 (6.8), 7.5(7.0), 7.4 (7.1) and 7.2 (6.9); mean PWC-WS scores (range 0-24) were 0.9 (1.7), 1.0 (1.7), 1.0 (1.8), and 0.9 (1.8); and mean PWC-DS scores (range 0-36) were 6.3 (5.6), 6.5 (5.7), 6.5 (5.8), and 6.3 (5.7), respectively. Complete analysis of data from the SUSTAIN-2 dataset will be presented. No indication of drug-specific withdrawal symptoms was seen after stopping ≥ 1-year of intermittent treatment with ESK nasal spray for TRD.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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