Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry? (NCT04781998) | Clinical Trial Compass
CompletedPhase 4
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
Denmark24 participantsStarted 2021-07-01
Plain-language summary
An open-label, multi-centre, 26-weeks clinical feasibility study. The objective is to explore whether Saxenda could be a feasible choice in the treatment of overweight, obesity and weight-related medical problems, in patients diagnosed with a severe mental illness and hospitalized at a forensic department in Denmark. We wish to determine the viability of the daily Saxenda®-injection treatment in this specific patient group.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Informed oral and written consent
✓. Diagnosed with a mental illness according to the criteria of ICD10
✓. Hospitalised at a forensic psychiatric department during the full inclusion period
✓. Age 18 years to 65 years (both included)
✓. BMI ≥27 kg/m2 with one or more weight-related comorbidities (sleep apnea, hypertension (BT ≥ 140/90 mmHg with no antihypertensive treatment. BT ≥ 130/80 mmHg with antihypertensive treatment), dyslipidaemia (LDL cholesterol ≥ 3 mmol/L), pre-diabetes (HbA1c 39-47 mmol/mol) or type 2 diabetes (HbA1c ≥ 48 mmol/mol)) or BMI ≥30 kg/m2
Exclusion criteria
✕. Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in "Informationsbekendtgørelsen § 10").
✕. Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant
✕. Women who are not willing to use an adequate contraceptive considered as highly effective (IUD or hormonal contraception during the full length of the study
✕. Impaired hepatic function (plasma liver transaminases \>2 times the upper normal limit)
✕. Impaired renal function (serum creatinine \>150 μmol/l and/or macroalbuminuria)
✕. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase \>2 times the upper normal limit)
What they're measuring
1
The primary endpoint is the number of "completers"
✕. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
✕. Hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg