Status:
COMPLETED
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
Lead Sponsor:
Anders Fink-Jensen, MD, DMSci
Conditions:
Mental Disorder
Metabolic Disturbance
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 medi...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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
- Any condition that the investigator feels would interfere with trial participation
- Use of weight-lowering pharmacotherapy within the preceding 3 months
- Type 1 diabetes
- Patients treated with insulin
- Patients treated with other GLP-1 receptor agonist medicines
- Known allergy to liraglutide or any of the ingredients in Saxenda®
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04781998
Start Date
July 1 2021
End Date
September 1 2022
Last Update
August 8 2023
Active Locations (1)
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1
Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.
Roskilde, Denmark, 4000