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Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies.

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Title: Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies.
Authors: DelBello, Melissa P., Findling, Robert L., Huss, Michael, Necking, Oscar, Petersen, Maria L., Schmidt, Simon N., Rosen, Monika
Source: European Child & Adolescent Psychiatry. Apr2025, Vol. 34 Issue 4, p1425-1434. 10p.
Subjects: Prevention of mental depression, Patient safety, Research funding, Suicidal ideation, Piperidine, Statistical sampling, Headache, Randomized controlled trials, Functional status, Antidepressants, Drug efficacy, Mental depression, Drug tolerance, Cognition, Nausea, Evaluation, Adolescence, Children
Abstract: Children and adolescents with severe or relapsing major depressive disorder (MDD) may require long-term antidepressant use, but safety and tolerability data on long-term treatment are limited. In a randomized, placebo-controlled trial in children and another in adolescents, vortioxetine and placebo groups showed improvement in MDD symptoms without statistically significant differences between groups. To gain insights on long-term safety and tolerability of vortioxetine in pediatric patients, participants from these two studies were enrolled in two long-term extension studies: 6 months (NCT02871297) followed by another 18 months (NCT03108625). Key safety measures included adverse events (AEs) and Columbia-Suicide Severity Rating Scale (C-SSRS); effectiveness measures included depression symptom severity, cognitive function, and overall functioning. Among the 662 patients in the 6-month extension, 61% experienced a treatment-emergent AE (TEAE), with the most common being nausea (20.8%); 2.1% had a serious AE (SAE), and 6% withdrew because of TEAEs. In the following 18-month extension (n = 94), 51% of patients experienced a TEAE, with the most common being headache (13.8%); no SAEs were reported. Based on the C-SSRS, 94% and 96% of patients reported no suicidal ideation or behavior in the 6- and 18-month studies, respectively. During the extension studies, patients continued to show improvement in depressive symptoms and cognitive and overall functioning, with > 50% of patients in remission at the end of each study, regardless of study treatment in the lead-in trial. Overall, vortioxetine remained well tolerated in pediatric patients with MDD who continued in the long-term extension studies with no observed increased risk in suicidal ideation. Trial registration: ClinicalTrials.gov ID: NCT02871297, August 18, 2016; ClinicalTrials.gov ID: NCT03108625, April 11, 2017. [ABSTRACT FROM AUTHOR]
Copyright of European Child & Adolescent Psychiatry is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies.
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  Data: <searchLink fieldCode="AR" term="%22DelBello%2C+Melissa+P%2E%22">DelBello, Melissa P.</searchLink><br /><searchLink fieldCode="AR" term="%22Findling%2C+Robert+L%2E%22">Findling, Robert L.</searchLink><br /><searchLink fieldCode="AR" term="%22Huss%2C+Michael%22">Huss, Michael</searchLink><br /><searchLink fieldCode="AR" term="%22Necking%2C+Oscar%22">Necking, Oscar</searchLink><br /><searchLink fieldCode="AR" term="%22Petersen%2C+Maria+L%2E%22">Petersen, Maria L.</searchLink><br /><searchLink fieldCode="AR" term="%22Schmidt%2C+Simon+N%2E%22">Schmidt, Simon N.</searchLink><br /><searchLink fieldCode="AR" term="%22Rosen%2C+Monika%22">Rosen, Monika</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22European+Child+%26+Adolescent+Psychiatry%22">European Child & Adolescent Psychiatry</searchLink>. Apr2025, Vol. 34 Issue 4, p1425-1434. 10p.
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  Data: <searchLink fieldCode="DE" term="%22Prevention+of+mental+depression%22">Prevention of mental depression</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+safety%22">Patient safety</searchLink><br /><searchLink fieldCode="DE" term="%22Research+funding%22">Research funding</searchLink><br /><searchLink fieldCode="DE" term="%22Suicidal+ideation%22">Suicidal ideation</searchLink><br /><searchLink fieldCode="DE" term="%22Piperidine%22">Piperidine</searchLink><br /><searchLink fieldCode="DE" term="%22Statistical+sampling%22">Statistical sampling</searchLink><br /><searchLink fieldCode="DE" term="%22Headache%22">Headache</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Functional+status%22">Functional status</searchLink><br /><searchLink fieldCode="DE" term="%22Antidepressants%22">Antidepressants</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+efficacy%22">Drug efficacy</searchLink><br /><searchLink fieldCode="DE" term="%22Mental+depression%22">Mental depression</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+tolerance%22">Drug tolerance</searchLink><br /><searchLink fieldCode="DE" term="%22Cognition%22">Cognition</searchLink><br /><searchLink fieldCode="DE" term="%22Nausea%22">Nausea</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation%22">Evaluation</searchLink><br /><searchLink fieldCode="DE" term="%22Adolescence%22">Adolescence</searchLink><br /><searchLink fieldCode="DE" term="%22Children%22">Children</searchLink>
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  Data: Children and adolescents with severe or relapsing major depressive disorder (MDD) may require long-term antidepressant use, but safety and tolerability data on long-term treatment are limited. In a randomized, placebo-controlled trial in children and another in adolescents, vortioxetine and placebo groups showed improvement in MDD symptoms without statistically significant differences between groups. To gain insights on long-term safety and tolerability of vortioxetine in pediatric patients, participants from these two studies were enrolled in two long-term extension studies: 6 months (NCT02871297) followed by another 18 months (NCT03108625). Key safety measures included adverse events (AEs) and Columbia-Suicide Severity Rating Scale (C-SSRS); effectiveness measures included depression symptom severity, cognitive function, and overall functioning. Among the 662 patients in the 6-month extension, 61% experienced a treatment-emergent AE (TEAE), with the most common being nausea (20.8%); 2.1% had a serious AE (SAE), and 6% withdrew because of TEAEs. In the following 18-month extension (n = 94), 51% of patients experienced a TEAE, with the most common being headache (13.8%); no SAEs were reported. Based on the C-SSRS, 94% and 96% of patients reported no suicidal ideation or behavior in the 6- and 18-month studies, respectively. During the extension studies, patients continued to show improvement in depressive symptoms and cognitive and overall functioning, with > 50% of patients in remission at the end of each study, regardless of study treatment in the lead-in trial. Overall, vortioxetine remained well tolerated in pediatric patients with MDD who continued in the long-term extension studies with no observed increased risk in suicidal ideation. Trial registration: ClinicalTrials.gov ID: NCT02871297, August 18, 2016; ClinicalTrials.gov ID: NCT03108625, April 11, 2017. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of European Child & Adolescent Psychiatry is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1007/s00787-024-02560-1
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      – Code: eng
        Text: English
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      – SubjectFull: Prevention of mental depression
        Type: general
      – SubjectFull: Patient safety
        Type: general
      – SubjectFull: Research funding
        Type: general
      – SubjectFull: Suicidal ideation
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      – SubjectFull: Piperidine
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              Text: Apr2025
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