Clinical TrialParallelEsketaminePlaceboCompleted

Clinical Study of Esketamine for Improving Depressive Symptoms in Patients With Lung Cancer After Smoking Cessation

Parallel-group controlled trial of intranasal esketamine (0.5 mg/kg) vs saline placebo in lung-cancer surgery patients with a long smoking history (≥20/day × 5+ years) undergoing smoking cessation. Target: 80 participants (40/40). Primary outcomes: HDRS-24, MADRS, CADSS, BPRS. Sponsor: Zhejiang Provincial People's Hospital, Hangzhou, China.

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Target Enrollment
80 participants
Study Type
interventional
Design
Randomized, double Blind

Study Arms & Interventions

Esketamine

experimental

Intranasal delivery of esketamine (ESK) once a week for 8 sessions.

Interventions

  • Esketamine0.5 mg/kg
    via Intranasal• weekly• 8 doses total

    Administered once a week for 8 sessions

Placebo

placebo

Intranasal delivery of normal saline placebo once a week for 8 sessions.

Interventions

  • Placebo
    via intranasal• weekly• 8 doses total

    Normal saline placebo with a bittering agent added to simulate the taste of esketamine

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment80 participants
  • Timeline
    Start: 2023-02-24
  • Compounds
    EsketaminePlacebo

Related Publications

PaywallindividualPrimary

Efficacy and safety of esketamine for smoking cessation among patients diagnosed with lung cancer and major depression disorder: A randomized, placebo-controlled clinical trial

This multicenter, randomised, placebo-controlled clinical trial (n=236) investigates the efficacy and safety of esketamine (ESK) (8x35mg) for smoking cessation in patients with lung cancer and major depressive disorder (MDD). Eight weekly intranasal ESK sessions significantly improved both self-reported (44.1%) and biologically verified (28.8%) smoking abstinence at 6-month follow-up, alongside reductions in depression, anxiety, nicotine dependence, and respiratory symptoms.

Published
Journal
Journal of Affective Disorders
Authors
Hong, C. J.

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