Effects of elexacaftor/tezacaftor/ivacaftor therapy on mental health of patients with cystic fibrosis

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Abstract

Introduction: The CFTR modulator drug elexacaftor/tezacaftor/ivacaftor (ETI) was shown to improve CFTR function and clinical symptoms in patients with cystic fibrosis (CF) with at least one F508del allele. Recently, some case reports suggested potential side effects of ETI on mental health with an increase in depressive symptoms and even suicide attempts in patients with CF. However, the general effects of this triple combination therapy on the mental health status of patients with CF remain largely unknown.

Methods: We, therefore, performed a prospective, observational study in a real-life setting and investigated the relationship between initiation of ETI therapy and changes in mental health in adult patients with CF. We assessed Cystic Fibrosis Questionnaire-Revised (CFQ-R), Patient Health Questionnaire-9 (PHQ-9), Beck’s Depression Inventory – Fast Screen (BDI-FS) and Generalized Anxiety Disorder 7-item Scale (GAD-7) at baseline and 8–16 weeks after initiation of ETI.

Results: In total, 70 adult patients with CF with at least one F508del allele and a median age of 27.9 years were recruited. After initiation of ETI, the CFQ-R respiratory domain score improved by 27.9 (IQR 5.6 to 47.2; p < 0.001). The PHQ-9 score of depressive symptoms decreased by 1.0 (IQR -3.0 to 0.3; p < 0.05) with an increase of 16.9% in the group with a minimal score after initiation of ETI and a decrease in the groups of mild (−11.3%) or moderate (−5.7%) scores compared to baseline. The BDI-FS score of depressive symptoms decreased from 1.0 (IQR 0.0–2.0) at baseline to 0.0 (IQR 0.0 to 2.0; p < 0.05) after initiation of ETI. The group with a minimal BDI-FS score increased by 8.0% after initiation of ETI, whereas the groups with mild (−4.9%), moderate (−1.6%) or severe (−1.6%) scores decreased compared to baseline. The GAD-7 score of anxiety symptoms did not change after initiation of ETI compared to baseline (0.0; IQR -2.0. to 0.0; p = 0.112).

Conclusion: Initiation of ETI improves symptoms of depression in adult patients with CF with at least one F508del allele. However, symptoms of anxiety do not change after short-term therapy with ETI.

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Most cited references 47

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A brief measure for assessing generalized anxiety disorder: the GAD-7.

Robert L Spitzer, Kurt Kroenke, Janet B W Williams … (2006)

Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.

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The PHQ-9: validity of a brief depression severity measure.

K Kroenke, R L Spitzer, J. Williams (2001)

While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.

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Prevalence of stress, anxiety, depression among the general population during the COVID-19 pandemic: a systematic review and meta-analysis

Nader Salari, Amin Hosseinian-Far, Rostam Jalali … (2020)

Background The COVID-19 pandemic has had a significant impact on public mental health. Therefore, monitoring and oversight of the population mental health during crises such as a panedmic is an immediate priority. The aim of this study is to analyze the existing research works and findings in relation to the prevalence of stress, anxiety and depression in the general population during the COVID-19 pandemic. Method In this systematic review and meta-analysis, articles that have focused on stress and anxiety prevalence among the general population during the COVID-19 pandemic were searched in the Science Direct, Embase, Scopus, PubMed, Web of Science (ISI) and Google Scholar databases, without a lower time limit and until May 2020. In order to perform a meta-analysis of the collected studies, the random effects model was used, and the heterogeneity of studies was investigated using the I2 index. Moreover. data analysis was conducted using the Comprehensive Meta-Analysis (CMA) software. Results The prevalence of stress in 5 studies with a total sample size of 9074 is obtained as 29.6% (95% confidence limit: 24.3–35.4), the prevalence of anxiety in 17 studies with a sample size of 63,439 as 31.9% (95% confidence interval: 27.5–36.7), and the prevalence of depression in 14 studies with a sample size of 44,531 people as 33.7% (95% confidence interval: 27.5–40.6). Conclusion COVID-19 not only causes physical health concerns but also results in a number of psychological disorders. The spread of the new coronavirus can impact the mental health of people in different communities. Thus, it is essential to preserve the mental health of individuals and to develop psychological interventions that can improve the mental health of vulnerable groups during the COVID-19 pandemic.

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Author and article information

Contributors

Linus Piehler: URI : https://loop.frontiersin.org/people/2232157/overview

Jobst Röhmel: URI : https://loop.frontiersin.org/people/1625874/overview

Mirjam Stahl: URI : https://loop.frontiersin.org/people/2154043/overview

Marcus A. Mall: URI : https://loop.frontiersin.org/people/612491/overview

Simon Y. Graeber: URI : https://loop.frontiersin.org/people/1787606/overview

Journal

Journal ID (nlm-ta): Front Pharmacol

Journal ID (iso-abbrev): Front Pharmacol

Journal ID (publisher-id): Front. Pharmacol.

Title: Frontiers in Pharmacology

Publisher: Frontiers Media S.A.

ISSN (Electronic): 1663-9812

Publication date (Electronic): 21 April 2023

Publication date Collection: 2023

Volume: 14

Electronic Location Identifier: 1179208

Affiliations

[1] ¹ Department of Pediatric Respiratory Medicine , Immunology and Critical Care Medicine and Cystic Fibrosis Center , Charité - Universitätsmedizin Berlin , Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin , Berlin, Germany

[2] ² German Center for Lung Research (DZL) , Associated partner site , Berlin, Germany

[3] ³ Berlin Institute of Health at Charité , Charité—Universitätsmedizin , Berlin, Germany

Author notes

Edited by: Burkhard Tümmler, Hannover Medical School, Germany

Reviewed by: Johanna Gardecki, Goethe University Frankfurt, Germany

Samia Hamouda, Hospital Children Béchir Hamza, Tunisia

C Virginia O'Hayer, Thomas Jefferson University Hospital, United States

Shanal Kumar, Queensland Health, Australia

*Correspondence: Simon Y. Graeber, Simon.Graeber@ 123456charite.de

[ † ]

These authors have contributed equally to this work and share first authorship

[ ‡ ]

These authors have contributed equally to this work and share senior authorship

Article

Publisher ID: 1179208

DOI: 10.3389/fphar.2023.1179208

PMC ID: 10160464

PubMed ID: 37153809

SO-VID: 75719806-27c9-4d68-ab75-4930001ffefd

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This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

History

Date received : 03 March 2023

Date accepted : 13 April 2023

Funding

Funded by: Bundesministerium für Bildung und Forschung , doi 10.13039/501100002347;

Award ID: 82DZL009B1

Funded by: Deutsche Forschungsgemeinschaft , doi 10.13039/501100001659;

Award ID: DFG; STA 1685-1/1

Funded by: Berlin Institute of Health , doi 10.13039/501100017268;

This study was supported by the German Federal Ministry of Education and Research (82DZL009B1) and the German Research Foundation (DFG; STA 1685-1/1). ST, MS, and SG are participants of the BIH-Charité Clinician Scientist Program funded by the Charité – Universitätsmedizin Berlin and the BIH.

Effects of elexacaftor/tezacaftor/ivacaftor therapy on mental health of patients with cystic fibrosis

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Neuropharmacology and Therapy

Most cited references 47

A brief measure for assessing generalized anxiety disorder: the GAD-7.

The PHQ-9: validity of a brief depression severity measure.

Prevalence of stress, anxiety, depression among the general population during the COVID-19 pandemic: a systematic review and meta-analysis

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