Severe mental illness Obesity MedDRA version: 20.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Saxenda
Product Name: Saxenda
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Other descriptive name: Saxenda
Conce
Sponsors
Mental Health Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 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 11. Type 1 diabetes. 12. Patients treated with insulin 13. Patients treated with other GLP-1 receptor agonist medicines 14. Known allergy to liraglutide or any of the ingredients in Saxenda
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the effectiveness of pharmacological treatment with liraglutide 3 mg (Saxenda®) for bodyweight management in patients with diagnosed with severe mental illness and excess weight (BMI =27 kg/m2) who also have bodyweight related medical problems or with severe mental illness and obesity (BMI =30 kg/m2), admitted to a forensic psychiatry department. The primary endpoint is the number of patients completing the study defined as “completers”. ;Secondary Objective: Secondary endpoints include reason(s) for drop out, changes in body weight, glycated haemoglobin A1c (HbA1c), blood pressure, heart rate, fibrosis-4 (FIB-4) score and lipid profile. ;Primary end point(s): The primary endpoint is the number of “completers”. A “completer” is defined as a patient maintaining a present level of compliance with the clinical trial medication and completing full study duration (26 weeks).;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include reason(s) for drop-out, changes in body weight, HbA1c, blood pressure, heart rate, FIB-4 score, and lipid profile. For patients enrolled in the study, all endpoints will initially be collected and several repeated during the full study duration.;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Countries
Denmark
Contacts
Public ContactMarie Reeberg Sass
Mental Health Center Copenhagen
Outcome results
None listed