Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib
This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements.
Lorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment.
Twenty-four adult patients with ALK/ROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg/day) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.
연구 개요
연구 유형
관찰
등록 (추정된)
24
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Felipe Canro, MD
- 전화번호: +57 310 8593083
- 이메일: felipe.canro@gmail.com
연구 장소
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Bogotá, 콜롬비아, 110131
- 모병
- Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
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연락하다:
- Liliana Gutiérrez, RN, MSc
- 전화번호: +573003768158
- 이메일: lgutierrez@fctic.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Adults (>= 18 years) with histologically confirmed advanced (stage IIIB/IV) lung adenocarcinoma harboring ALK or ROS1 fusions, currently receiving lorlatinib as standard care, and initiating vortioxetine for NAE management.
설명
Inclusion Criteria:
- Histologically confirmed diagnosis of ALK/ROS1-positive non-small cell lung cancer (NSCLC), stage IIIB/IV.
- Currently receiving lorlatinib as part of the standard therapeutic regimen.
- Documented neurocognitive adverse events (NAEs) attributable to lorlatinib.
- Age >= 18 years.
- ECOG performance status 0-2.
- Ability to understand and sign informed consent.
- Expected survival >= 6 months.
- Planned initiation of vortioxetine as part of standard care.
- Ability to complete neuropsychological tests and questionnaires in Spanish.
Exclusion Criteria:
- Prior diagnosis of major cognitive impairment unrelated to cancer treatment.
- Current use of another antidepressant that cannot be discontinued.
- Uncontrolled major psychiatric disorder.
- History of uncontrolled epilepsy or recent seizures.
- Severe hepatic or renal impairment.
- Known hypersensitivity to vortioxetine.
- Participation in another clinical trial within the past 30 days.
- Inability to provide informed consent.
- Life expectancy < 3 months.
- Contraindications to vortioxetine (e.g., concomitant MAOI use).
- Prior vortioxetine use.
- Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Psychomotor Speed
기간: Baseline, Week 6, Week 12
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Digit Symbol Substitution Test (DSST).
The DSST measures psychomotor speed and sustained attention.
Participants match symbols to digits within a fixed time limit.
Score range: 0 to 90 (number of correct substitutions in 90 seconds); higher scores indicate better cognitive performance.
Within-subject change from baseline analyzed using ANCOVA.
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Baseline, Week 6, Week 12
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Processing Speed and Visual Attention
기간: Baseline, Week 6, Week 12
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Trail Making Test Part A (TMT-A).
The TMT-A measures processing speed and visual scanning.
The outcome is time to completion in seconds; lower scores indicate better performance.
Clinically meaningful change assessed using the Reliable Change Index (RCI).
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Baseline, Week 6, Week 12
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Executive Function and Cognitive Flexibility
기간: Baseline, Week 6, Week 12
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Trail Making Test Part B (TMT-B).
The TMT-B measures executive function and set-shifting ability.
The outcome is time to completion in seconds; lower scores indicate better performance.
Clinically meaningful change assessed using the Reliable Change Index (RCI).
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Baseline, Week 6, Week 12
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Selective and Sustained Attention
기간: Baseline, Week 6, Week 12
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D2-R Test of Attention.
The D2-R Test of Attention measures selective and sustained visual attention.
The primary metric is the Total Concentration Performance score (TN-E), calculated as total items processed minus errors.
Score range: 0 to 299; higher scores indicate better attentional performance.
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Baseline, Week 6, Week 12
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Working Memory
기간: Baseline, Week 6, Week 12
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Wechsler Adult Intelligence Scale IV (WAIS-IV), Working Memory Index.
The WAIS-IV Working Memory Index is a standardized composite score derived from Digit Span and Arithmetic subtests.
Score range: 45 to 155 (mean 100, SD 15); higher scores indicate better working memory capacity.
Change from baseline analyzed using linear mixed-effects models (LMM).
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Baseline, Week 6, Week 12
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Processing Speed
기간: Baseline, Week 6, Week 12
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Wechsler Adult Intelligence Scale IV (WAIS-IV), Processing Speed Index.
The WAIS-IV Processing Speed Index is a standardized composite score derived from Coding and Symbol Search subtests.
Score range: 45 to 155 (mean 100, SD 15); higher scores indicate better processing speed.
Change from baseline analyzed using LMM.
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Baseline, Week 6, Week 12
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Verbal Learning and Memory
기간: Baseline, Week 6, Week 12
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California Verbal Learning Test (CVLT).
The California Verbal Learning Test measures verbal learning and episodic memory across five immediate recall trials plus short- and long-delay recall.
Primary metric: Total Learning Trials 1-5 (score range: 0 to 80); higher scores indicate better verbal memory performance.
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Baseline, Week 6, Week 12
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Language
기간: Baseline, Week 6, Week 12
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Phonemic Verbal Fluency Task.
Phonemic verbal fluency is measured by the total number of words beginning with a specified letter generated in 60 seconds.
There is no fixed maximum; higher scores indicate better phonemic language production and frontal-executive function.
The average of three letter trials (F, A, S) will be reported.
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Baseline, Week 6, Week 12
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Language
기간: Baseline, Week 6, Week 12
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Semantic Verbal Fluency Task.
Semantic verbal fluency is measured by the total number of words from a specified semantic category generated in 60 seconds.
There is no fixed maximum; higher scores indicate better semantic retrieval and language functioning.
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Baseline, Week 6, Week 12
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Frontal Lobe and Executive Function
기간: Baseline, Week 6, Week 12
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INECO Frontal Screening (IFS).
The INECO Frontal Screening (IFS) evaluates frontal lobe functions including motor programming, verbal fluency inhibitory control, working memory, abstraction capacity, and reflex suppression.
Score range: 0 to 30; higher scores indicate better executive and frontal lobe functioning.
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Baseline, Week 6, Week 12
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Subjective Cognitive Complaints
기간: Baseline, Week 6, Week 12
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Perceived Deficits Questionnaire (PDQ), Attention/Concentration Subscore.
The PDQ Attention/Concentration subscore measures self-reported cognitive difficulties in attention and concentration.
Subscore range: 0 to 20; higher scores indicate greater perceived cognitive impairment.
Analyzed using mixed models for repeated measures (MMRM).
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Baseline, Week 6, Week 12
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Subjective Cognitive Complaints
기간: Baseline, Week 6, Week 12
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Perceived Deficits Questionnaire (PDQ), Planning/Organization Subscore.
The PDQ Planning/Organization subscore measures self-reported difficulties in planning and organizational ability.
Subscore range: 0 to 20; higher scores indicate greater perceived impairment.
Analyzed using MMRM.
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Baseline, Week 6, Week 12
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Clinical Global Impression of Improvement (CGI-I)
기간: Baseline, Week 6, Week 12
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The Clinical Global Impressions-Improvement scale (CGI-I) is a clinician-rated measure of overall clinical improvement relative to baseline.
Score range: 1 (very much improved) to 7 (very much worse); lower scores indicate greater improvement.
Response is defined as a score of 1 or 2. Analyzed using MMRM.
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Baseline, Week 6, Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depressive Symptoms
기간: Baseline, Week 6, Week 12, Month 6
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Montgomery-Asberg Depression Rating Scale (MADRS).
The MADRS is a clinician-administered scale measuring severity of depressive symptoms across 10 items.
Score range: 0 to 60; higher scores indicate greater depression severity.
Response defined as >= 50% reduction from baseline; remission defined as score < 10.
MCID: >= 50% reduction.
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Baseline, Week 6, Week 12, Month 6
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Depressive Symptoms
기간: Baseline, Week 6, Week 12
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Patient Health Questionnaire (PHQ-9).
The PHQ-9 is a 9-item self-report scale for depression screening and severity assessment.
Score range: 0 to 27; higher scores indicate greater depressive symptom burden.
Severity categories: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27).
MCID: >= 5-point reduction.
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Baseline, Week 6, Week 12
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Health-Related Quality of Life
기간: Baseline, Month 1, 2, 3, 6, 12
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36-Item Short Form Health Survey (SF-36), Physical Component Summary (PCS).
The SF-36 Physical Component Summary (PCS) is a norm-based composite score derived from four SF-36 subscales (physical functioning, role-physical, bodily pain, general health).
Score range: 0 to 100; higher scores indicate better physical health status.
MCID: >= 4 points.
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Baseline, Month 1, 2, 3, 6, 12
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Health-Related Quality of Life
기간: Baseline, Month 1, 2, 3, 6, 12
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36-Item Short Form Health Survey (SF-36), Mental Component Summary (MCS).
The SF-36 Mental Component Summary (MCS) is a norm-based composite score derived from four SF-36 subscales (vitality, social functioning, role-emotional, mental health).
Score range: 0 to 100; higher scores indicate better mental health status.
MCID: >= 4 points.
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Baseline, Month 1, 2, 3, 6, 12
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Life Satisfaction
기간: Baseline, Month 1, 2, 3, 6, 12
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Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF).
The Q-LES-Q-SF measures overall enjoyment and satisfaction with daily life across 14 items rated on a 5-point Likert scale (1 = very poor to 5 = very good).
Total score range: 14 to 70; higher scores indicate greater life satisfaction.
Items 15 and 16 are scored separately and not included in the total.
MCID: >= 9 points.
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Baseline, Month 1, 2, 3, 6, 12
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Health Utility
기간: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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EuroQol 5-Dimension Questionnaire (EQ-5D), Utility Index.
The EQ-5D utility index is derived from five health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) using the Spanish value set.
Score range: -0.654 to 1.0; higher scores indicate better health utility (1.0 = full health, 0 = death).
MCID: >= 0.1.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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Self-Rated Health
기간: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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EuroQol Visual Analogue Scale (EQ-VAS).
The EQ-VAS is a vertical visual analogue scale for overall self-rated health.
Score range: 0 to 100; higher scores indicate better self-rated health (100 = best imaginable health state).
MCID: >= 7 points.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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Functional Capacity
기간: Baseline, Week 6, Week 12
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University of California San Diego Performance-Based Skills Assessment (UPSA), Composite Score.
The UPSA composite score combines the UPSA-VIM and UPSA-Brief to measure real-world functional capacity across domains including finance and communication.
Score range: 0 to 100; higher scores indicate better functional performance.
Analyzed using ANCOVA.
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Baseline, Week 6, Week 12
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Work Limitations
기간: Baseline, Week 6, Week 12, Month 6
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Work Limitations Questionnaire (WLQ).
The WLQ measures the degree to which health problems interfere with job performance across four scales: time management, physical demands, mental-interpersonal demands, and output demands.
Each scale is scored 0 to 100; higher scores indicate greater work limitation.
An overall WLQ productivity loss score will also be reported.
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Baseline, Week 6, Week 12, Month 6
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Cognitive and Physical Functioning
기간: Baseline, Week 6, Week 12
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Cognitive and Physical Functioning Questionnaire (CPFQ).
The CPFQ is a 7-item self-report instrument measuring cognitive and physical energy symptoms relevant to depression and related conditions.
Score range: 7 to 42; higher scores indicate greater cognitive and physical impairment.
Analyzed only in participants with a baseline score > 25.
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Baseline, Week 6, Week 12
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Tumor Response to Lorlatinib
기간: Month 2, Month 6, Month 12
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Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Tumor response is assessed by contrast-enhanced CT scan per RECIST version 1.1 criteria.
Response is classified as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Best overall response will be documented for each participant.
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Month 2, Month 6, Month 12
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Adverse Events
기간: All scheduled visits, from baseline through 30 days post-last visit
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Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
All adverse events (AEs) will be graded by type, severity (Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening; Grade 5: death), and causality attribution (unrelated / unlikely / possible / probable / definitely related to vortioxetine).
Predefined study suspension thresholds: > 25% Grade 3, > 10% Grade 4, or > 3% Grade 5 AEs attributable to vortioxetine.
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All scheduled visits, from baseline through 30 days post-last visit
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 10일
기본 완료 (추정된)
2027년 3월 10일
연구 완료 (추정된)
2027년 11월 10일
연구 등록 날짜
최초 제출
2026년 4월 14일
QC 기준을 충족하는 최초 제출
2026년 6월 4일
처음 게시됨 (실제)
2026년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 4일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Vortioxetina
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .