The effectiveness of pharmacological treatment with the glucagon-like peptide-1 receptor agonist Liraglutide 3mg (Saxenda®) once-daily for weight management in forensic psychiatry; An Exploratory pilot study.

Mental Health Center Copenhagen0 sites40 target enrollmentAugust 30, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 30, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Mental Health Center Copenhagen

•1\.Informed oral and written consent
•2\.Diagnosed with a mental illness
•3\.Hospitalised at a forensic psychiatric department
•4\.Age 18 years to 65 years (both included)
•5\.BMI \=27 kg/m2 with one or more weight\-related comorbidities (hypertension, dyslipidaemia, pre\-diabetes or type 2 diabetes) or BMI \=30 kg/m2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 38
•F.1\.3 Elderly (\>\=65 years) yes

•1\.Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in Informationsbekendtgørelsen § 10”).
•2\.Fertile females of child\-bearing potential who are pregnant, breast\-feeding or have the intention of becoming pregnant
•3\.Women who are not willing to use adequate contraceptive during the full length of the study
•4\.Impaired hepatic function (plasma liver transaminases \>2 times the upper normal limit)
•5\.Impaired renal function (serum creatinine \>150 µmol/l and/or macroalbuminuria)
•6\.Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase \>2 times the upper normal limit)
•7\.Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
•8\.Hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg
•9\.Any condition that the investigator feels would interfere with trial participation
•10\.Use of weight\-lowering pharmacotherapy within the preceding 3 months