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Aerobic Versus Leisure Group for Adolescents With Depression

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 26, 2025 (before its estimated June 10, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Eligibility criteria revised
    • Study description expanded, about 96 words
    • Study sites revised (4)
    • Publications: 1 to 3
    v5
  2. Primary completion date: Mar 2025 to Jun 10, 2025v4 Show 4 more changesShow less
    • Study completion date: Aug 2025 to Mar 10, 2026
    • Secondary endpoints: 18 to 20
    • Study description expanded, about 43 words
    • Site details revised at 2 of 4 sites
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary completion date: Mar 2024 to Mar 2025
    • Study sites: 1 to 4
    • Study completion date: Mar 2025 to Aug 2025
    • Start date changed from estimate of Feb 2022 to Feb 28, 2022
    • Secondary endpoints: 17 to 18
    • Study description expanded, about 127 words
  4. Secondary endpoints: 10 to 17
    • Study description shortened, about 121 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05076214
Lead Sponsor Lund University Hospital
Collaborators: Region Halland, Halmstad University, Karolinska University Hospital, The Rydberg Laboratory for Applied Sciences, Halmstad, Sweden, Region Skane, PRIMA Barn- och Vuxenpsykiatri AB
Conditions
(from sponsor)		 Depressive Disorder, Major
Related terms Depression, Major Depressive Disorder
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov