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Life sciences · Interventional Study
ClinicalTrials.gov · November 4, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05076214). This is a study registration, not published results. Lead sponsor: Lund University Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 125 participants (ACTUAL). Conditions: Depressive Disorder, Major. Interventions: BEHAVIORAL: Aerobic exercise in group; BEHAVIORAL: Leisure activities in group. Primary outcome measures: Change in Children's Depression Rating Scale- Revised (CDRS-R) , After intervention (at 13 weeks = primary endpoint) but also at 26 weeks (still blinded)and at follow-up (at 52 weeks, non-blinded). Brief summary: The aim is to evaluate aerobic group exercise versus leisure group activities in adolescents with mild to moderate depression. Primary outcome is Children's Depression Rating Scale - Revised (CDRS-R). Secondary outcomes are Clinical Global Impressions - Severity and Improvement scales (CGI), self-reported Quick Inventory of Depression Symptomatology (QIDS- A17-SR), the self-reported Outcome Rating Scale (ORS), clinician rated Children Global Assessment Scale (C-GAS), aerobic capacity (VO2max), muscular strength, body, Body Mass Index (BMI), presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples and a cost evaluation rated by parents with Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (Tic-P) and the Child Health Utility (CHU9D) to facilitate estimation of Quality Adjusted Life Years. Further objectives are qualitative interviews to explore adolescents' experiences of the intervention as well as how their health and lifestyle are influenced and a validation of QIDS- A17-C and QIDS- A17-SR versus CDRS-R will be performed.