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Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3.

Publication ,  Journal Article
Ochs-Ross, R; Daly, EJ; Zhang, Y; Lane, R; Lim, P; Morrison, RL; Hough, D; Manji, H; Drevets, WC; Sanacora, G; Steffens, DC; Adler, C ...
Published in: Am J Geriatr Psychiatry
February 2020

BACKGROUND: Elderly patients with major depression have a poorer prognosis, are less responsive to treatment, and show greater functional decline compared with younger patients, highlighting the need for effective treatment. METHODS: This phase 3 double-blind study randomized patients with treatment-resistant depression (TRD) ≥65 years (1:1) to flexibly dosed esketamine nasal spray and new oral antidepressant (esketamine/antidepressant) or new oral antidepressant and placebo nasal spray (antidepressant/placebo). The primary endpoint was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to day 28. Analyses included a preplanned analysis by age (65-74 versus ≥75 years) and post-hoc analyses including age at depression onset. RESULTS: For the primary endpoint, the median-unbiased estimate of the treatment difference (95% CI) was -3.6 (-7.20, 0.07); weighted combination test using MMRM analyses z = 1.89, two-sided p = 0.059. Adjusted mean (95% CI) difference for change in MADRS score between treatment groups was -4.9 (-8.96, -0.89; t = -2.4, df = 127; two-sided nominal p = 0.017) for patients 65 to 74 years versus -0.4 (-10.38, 9.50; t = -0.09, two-sided nominal p = 0.930) for those ≥75 years, and -6.1 (-10.33, -1.81; t = -2.8, df = 127; two-sided nominal p = 0.006) for patients with depression onset <55 years and 3.1 (-4.51, 10.80; t = 0.8, two-sided nominal p = 0.407) for those ≥55 years. Patients who rolled over into the long-term open-label study showed continued improvement with esketamine following 4 additional treatment weeks. CONCLUSIONS: Esketamine/antidepressant did not achieve statistical significance for the primary endpoint. Greater differences between treatment arms were seen for younger patients (65-74 years) and patients with earlier onset of depression (<55 years).

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Published In

Am J Geriatr Psychiatry

DOI

EISSN

1545-7214

Publication Date

February 2020

Volume

28

Issue

2

Start / End Page

121 / 141

Location

England

Related Subject Headings

  • Treatment Outcome
  • Nasal Sprays
  • Male
  • Ketamine
  • Humans
  • Geriatrics
  • Female
  • Drug Therapy, Combination
  • Double-Blind Method
  • Depressive Disorder, Treatment-Resistant
 

Citation

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Ochs-Ross, R., Daly, E. J., Zhang, Y., Lane, R., Lim, P., Morrison, R. L., … Singh, J. B. (2020). Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3. Am J Geriatr Psychiatry, 28(2), 121–141. https://doi.org/10.1016/j.jagp.2019.10.008
Ochs-Ross, Rachel, Ella J. Daly, Yun Zhang, Rosanne Lane, Pilar Lim, Randall L. Morrison, David Hough, et al. “Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3.Am J Geriatr Psychiatry 28, no. 2 (February 2020): 121–41. https://doi.org/10.1016/j.jagp.2019.10.008.
Ochs-Ross R, Daly EJ, Zhang Y, Lane R, Lim P, Morrison RL, et al. Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3. Am J Geriatr Psychiatry. 2020 Feb;28(2):121–41.
Ochs-Ross, Rachel, et al. “Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3.Am J Geriatr Psychiatry, vol. 28, no. 2, Feb. 2020, pp. 121–41. Pubmed, doi:10.1016/j.jagp.2019.10.008.
Ochs-Ross R, Daly EJ, Zhang Y, Lane R, Lim P, Morrison RL, Hough D, Manji H, Drevets WC, Sanacora G, Steffens DC, Adler C, McShane R, Gaillard R, Wilkinson ST, Singh JB. Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression-TRANSFORM-3. Am J Geriatr Psychiatry. 2020 Feb;28(2):121–141.
Journal cover image

Published In

Am J Geriatr Psychiatry

DOI

EISSN

1545-7214

Publication Date

February 2020

Volume

28

Issue

2

Start / End Page

121 / 141

Location

England

Related Subject Headings

  • Treatment Outcome
  • Nasal Sprays
  • Male
  • Ketamine
  • Humans
  • Geriatrics
  • Female
  • Drug Therapy, Combination
  • Double-Blind Method
  • Depressive Disorder, Treatment-Resistant