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Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study.

Publication ,  Journal Article
Ochs-Ross, R; Wajs, E; Daly, EJ; Zhang, Y; Lane, R; Lim, P; Drevets, WC; Steffens, DC; Sanacora, G; Jamieson, C; Hough, D; Manji, H; Singh, JB
Published in: Am J Geriatr Psychiatry
May 2022

BACKGROUND: Older, compared with younger, patients with treatment-resistant depression (TRD) typically have lower response and remission rates with poorer tolerability to antidepressant treatment. This post-hoc analysis compared outcomes following treatment with esketamine nasal spray (ESK) between younger (18-64 years) and older (≥65 years) patients with TRD. METHODS: SUSTAIN-2, an up to 1-year open-label safety and efficacy study of ESK plus an oral antidepressant, included patients with TRD either directly enrolled (≥18-year) or transferred from a phase 3 double-blind study, TRANSFORM-3 (≥65-year). Patients were treated in two phases: 4-week induction and 48-week optimization/maintenance. RESULTS: Younger (n = 624) and older (n = 178) patients had similar baseline characteristics except for hypertension history (21.5% versus 48.3%, respectively). Patients (younger versus older) had similar mean baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and mean (SD) reductions in MADRS total scores for induction (-18.0 [7.19] versus -18.1 [9.37]; p = 0.492 [t = 0.69, df = 701]) and optimization/maintenance (week 12) (-19.9 [7.03] versus -22.2 [9.50]; p = 0.265 [t = -1.12, df = 3470]) phases. Treatment-emergent adverse events (TEAEs) reported in younger versus older patients, respectively, were: induction, 86.1% versus 74.8%; optimization/maintenance, 86.8% versus 81.0%; serious TEAEs: induction, 2.2% versus 1.9%; optimization/maintenance, 6.7% versus 4.8%; TEAEs of increased blood pressure: induction, 6.9% versus 6.5%; optimization/maintenance, 7.1% versus 9.5%; and falls: induction, 0.3% versus 0.6%; optimization/maintenance, 0.2% versus 0.8%. Cognitive tests did not show clinically meaningful differences between the age groups. CONCLUSIONS: Although limited by the open-label design of SUSTAIN-2, this post-hoc analysis showed generally comparable improvement in depression between ESK-treated younger and older adult patients with TRD, with consistent safety outcomes.

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Published In

Am J Geriatr Psychiatry

DOI

EISSN

1545-7214

Publication Date

May 2022

Volume

30

Issue

5

Start / End Page

541 / 556

Location

England

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Nasal Sprays
  • Middle Aged
  • Ketamine
  • Humans
  • Geriatrics
  • Drug Therapy, Combination
  • Double-Blind Method
  • Depression
 

Citation

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Ochs-Ross, R., Wajs, E., Daly, E. J., Zhang, Y., Lane, R., Lim, P., … Singh, J. B. (2022). Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study. Am J Geriatr Psychiatry, 30(5), 541–556. https://doi.org/10.1016/j.jagp.2021.09.014
Ochs-Ross, Rachel, Ewa Wajs, Ella J. Daly, Yun Zhang, Rosanne Lane, Pilar Lim, Wayne C. Drevets, et al. “Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study.Am J Geriatr Psychiatry 30, no. 5 (May 2022): 541–56. https://doi.org/10.1016/j.jagp.2021.09.014.
Ochs-Ross R, Wajs E, Daly EJ, Zhang Y, Lane R, Lim P, Drevets WC, Steffens DC, Sanacora G, Jamieson C, Hough D, Manji H, Singh JB. Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study. Am J Geriatr Psychiatry. 2022 May;30(5):541–556.
Journal cover image

Published In

Am J Geriatr Psychiatry

DOI

EISSN

1545-7214

Publication Date

May 2022

Volume

30

Issue

5

Start / End Page

541 / 556

Location

England

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Nasal Sprays
  • Middle Aged
  • Ketamine
  • Humans
  • Geriatrics
  • Drug Therapy, Combination
  • Double-Blind Method
  • Depression