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. |
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| 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] |
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| Database: | Psychology and Behavioral Sciences Collection |
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| 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] |
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| ISSN: | 10188827 |
| DOI: | 10.1007/s00787-024-02560-1 |
