Efficacy and Safety Analyses of Mirtazapine in NSCLC Patients With Depression

NCT02650544 | Unknown Phase 2 DMC

• 1 other identifier: MDES20150107
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung; Depression

Keywords

Carcinoma, Non-Small-Cell Lung; Depression; mirtazapine; patients health questionnaire (PHQ-9)

Outcome Measures

Primary Outcomes (1)

• Number of participants responded to treatment.

  Using PHQ-9 or HAMD-17 questionnaire to assess the change of depression scores at the time points above. The measure unit is questionnaire score point, remain the same at every time points. And to calculate response number of patients (patients had 50% percent of depression questionnaire score points reduction compared to baseline after treatment initiation) and recovery number of patients (patients had PHQ-9 score less than 8 points PHQ-9 score less than 8 points during the treatment).

  baseline, and 3 weeks (d22), and 8 weeks (d57), and follow-up (d71, d85)

Secondary Outcomes (2)

• Response duration

  From date of randomization until the date of first documented regression recurrence, assessed up to 12 weeks"

• Number of participants had quality of life improvement

  baseline, and 3 weeks (d22), and 8 weeks (d57), and follow-up (d71, d85)

Study Arms (2)

mirtazapine

EXPERIMENTAL

Mirtazapine arm will be orally administered with mirtazapine 15mg, QD, consecutive medication for 8 weeks; along with palliative chemotherapy regimen decided by investigators.

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

Placebo arm will be orally administered with placebo 15mg, QD, consecutive medication for 8 weeks; along with palliative chemotherapy regimen decided by investigators.

Drug: Placebo

Interventions

Mirtazapine DRUG

Patients in mirtazapine arm will be orally administered mirtazapine as an anti-depression therapy; along with palliative chemotherapy.

Also known as: Treatment arm: mirtazapine administration

mirtazapine

Placebo DRUG

Patients in placebo arm will be orally administered placebo; along with palliative chemotherapy.

Also known as: Comparative arm: placebo administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology confirmed non-small cell lung cancer, undertaking palliative chemotherapy
• Age above 18 years old
• PHQ-9 score ≥ 8 points at baseline assessment
• Eastern Cooperative Oncology Group (ECOG) performance score 0 -2
• Orally administration of drugs without difficulties
• Eligible bone marrow function, liver and kidney function for chemotherapy
• Pregnancy test negative in 7 days for women of child-bearing age; willing to take contraception measures.
• Signed Informed consent form (ICF)

You may not qualify if:

• Clinical diagnosis of depression before advanced NSCLC confirmed
• Suicide tendency or behavior
• Mania in past medical history
• Received surgery or radiation therapy in 4 weeks
• Central nervous system (CNS) metastasis or spinal compression; except no symptoms and with no cortical hormonotherapy in 4 weeks.
• Systemically treatment with psychotropic medications, antihistamines drugs, antibiotics, cortical hormone therapy, antiepileptic drugs, immunosuppressive agents or other drugs might affect treatment in 4 weeks; or locally used of these drug in 2 weeks.
• AST or ALT ≥ 2.5 ULN without liver metastasis; or ≥ 5 ULN with liver metastasis.
• Serum creatinine ≥ 2 mg/dl
• Residual toxicity event ≥ CTCAE grade 2, except peripheral neurotoxicities.
• Any severe or uncontrolled systemic diseases judged by investigators.
• Any contraindication of mirtazapine.
• Invalid subject after randomization
• Major protocol violations judged by investigators.
• Poor compliance
• Intolerable adverse events

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun-Yat Sen University (CCSYSU)

Guangzhou, Guangdong, 510060, China

Location

Related Publications (30)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Depression

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Li Zhang, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. and Professor

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: January 8, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

CN (1)