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Clinical Trial Details

Trial ID: L6745
Source ID: NCT05492305
Associated Drug: Glp-1 Receptor Agonist
Title: Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Obesity|Mental Health Issue
Interventions: DRUG: GLP-1 receptor agonist
Outcome Measures: Primary: subjective effect of GLP1 receptor agonist on mental health, qualitative analysis of the subjective effect of GLP1 receptor agonist on mental health in patients with diabetes and obesity (determined at stage 2 using the semi-structured interview), 12-16 weeks | Secondary: subjective effect of GLP1 receptor agonist on general wellbeing, qualitative analysis of the subjective effect of GLP1 receptor agonist on general wellbeing (determined at stage 2 using the semi-structured interview), 12-16 weeks|subjective effect of GLP1 receptor agonist on eating behaviours, qualitative analysis of the subjective effect of GLP1 receptor agonist on eating behaviours (determined at stage 2 using the semi-structured interview), 12-16 weeks|subjective effect of GLP1 receptor agonist on binge eating, if present, qualitative analysis of the subjective effect of GLP1 receptor agonist on binge eating, if present (determined at stage 2 using the semi-structured interview), 12-16 weeks|mean change in patient health questionnaire 9 (PHQ9) score with GLP1 receptor agonist over 12-16 weeks, mean change in PHQ9 score with GLP1 receptor agonist over 12-16 weeks (determined at stage 2 by comparing the questionnaire scores from stages 1 and 2). Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe., 12-16 weeks|mean change in generalised anxiety disorder assessment (GAD) score with GLP1 receptor agonist over 12-16 weeks, mean change in GAD score with GLP1 receptor agonist over 12-16 weeks (determined at stage 2 by comparing the questionnaire scores from stages 1 and 2). Score between 0 and 21; scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively., 12-16 weeks|mean change in eating disorder examination questionnaire (EDE-Q) score with GLP1 receptor agonist over 12-16 weeks, mean change in EDE-Q score with GLP1 receptor agonist over 12-16 weeks (determined at stage 2 by comparing the questionnaire scores from stages 1 and 2). Score between 0 and 168, higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes, 12-16 weeks
Sponsor/Collaborators: Sponsor: King's College London
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 20
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-09
Completion Date: 2023-08
Results First Posted:
Last Update Posted: 2022-09-26
Locations: Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05492305