CompletedNot Applicable

Impact of the Introduction of ORKAMBI on Anxiety, Depression, Quality of Life and Adherence of Adolescents and Young Adults

France19 participantsStarted 2017-12-01

Plain-language summary

The aim of this project is to evaluate the psychological reshuffle induced by ORKAMBI. The particular focus of this study is the consequence of its introduction on anxiety, depression, quality of life and adherence to all cystic fibrosis (CF) treatment. To answer this question investigators will monitor the psychological function of CF adolescents and young adults treated with ORKAMBI and compare them to CF adolescents and young adults not treated with ORKAMBI.

Who can participate

Age range12 Years – 20 Years

SexALL

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Inclusion Criteria: * Treated group: Patients with proven CF (sweat-test \> 60 mEq, 2 DF508 CF causing mutations, 12 to 20 years, and treated with ORKAMBI * Control group: Patients not carrying 2 DF508 CF causing mutations, not treated with ORKAMBI, and not carrying the G551D, G178R, S549N, S549R, G551S, G1244E,S1251N, S1255P or G1349D mutation or treated with Kalydeco Exclusion Criteria: * Transplanted patients * Patients younger than 12 years * Patients older than 20 years

What they're measuring

Score of Generalized Anxiety Disorder-7 questionnaire (GAD-7)

Timeframe: 24 months

Trial details

NCT IDNCT03659214

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-01-19

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