Efficacy and Safety Analyses of Mirtazapine in NSCLC Patients With Depression
Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
This is a phase II, placebo-controlled, randomized, double-blinded clinical trial. Study
objective is to assess the efficacy and safety of mirtazapine in advanced NSCLC patients with
malignant tumor related depression. Study hypothesis is that advanced NSCLC diagnosed with
depression undertaking palliative chemotherapy with mirtazapine treatment for 8 weeks will
have remarkable improvement in depression compared to baseline. Eligible advanced NSCLC
Patients with PHQ-9 score ≥ 8, and undertaking palliative chemotherapy will be enrolled into
this study. patients will be stratified (gender, age, Numerical Rating Scale score for cancer
pain 0-3/4-6/7-10) randomized (1:1) into mirtazapine or placebo treatment. Patients in
mirtazapine arm will be orally administered with mirtazapine 15mg, QD, consecutive medication
for 8 weeks; along with palliative chemotherapy regimen decided by investigators. Patients in
placebo arm will be orally administered with placebo 15mg, QD, consecutive medication for 8
weeks; along with palliative chemotherapy regimen decided by investigators. During the
treatment, Patient health questionnaire (PHQ-9), Hamilton Depression Scale (HAMD-17) and
European Organization for Research on Treatment of Cancer (EORTC) quality of life
questionnaire-C30 (QLQ-C30) questionnaires will be collected at baseline, 3 weeks (d22) and 8
weeks (d57), or treatment discontinuation date due to depression deteriorated or suicidal
tendency and behavior. Follow-up will last up to 4 weeks after treatment end with depression
assessment (questionnaires every 2 weeks). Study endpoints: primary endpoint is the
anti-depression efficacy (response rate). Response defined as the PHQ-9 or HAMD-17
questionnaire score decrease ≥ 50% compared with baseline level.