Schizophrenia spectrum disorder MedDRA version: 20.0 Level: LLT Classification code 10052792 Term: Schizophrenia, undifferentiated type System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Ozempic
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: semaglutid
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Concentration unit: mg m
Sponsors
Mental Healt Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed oral and written consent. 2. Diagnosed with a schizophrenia spectrum disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association. 3. Initiating current daily treatment with clozapine or olanzapine, respectively, within 60 months. 4. Age 18 years to 65 years (both included). 5. Body mass index (BMI) =25 kg/m2. 6. Diagnosed with prediabetes or type 2 diabetes, with the following plasma levels: Prediabetes: HbA1c 35-47 mmol/mol or fasting plasma glucose (FPG) 5.6-6.9 mM or 2-h during 75 mg OGGT 7.8-11.0 mM. The test result has to be confirmed on a different day. Type 2 diabetes: HbA1c 48-57 mmol/mol or fasting plasma glucose (FPG) 6.9-9.9 mM or 2h OGTT > 11 mM (although FPG and HbA1c might still be under the diagnostic range). The test result has to be confirmed on a different day. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Acute worsening of psychosis based on a clinical evaluation (score of 6 or 7 on the CGI-S scale). 2. Coercive measures 3. Females of child-bearing potential who are pregnant, breastfeeding, or have the intention of becoming pregnant. 4. Women who are not willing to use an adequate contraceptive during the full length of the study. 5. Patients treated with corticosteroids or other hormone therapy (except oestrogens). 6. Any active substance abuse or dependence (except for nicotine). 7. Impaired hepatic function (plasma liver transaminases >3 times upper normal limit). 8. Impaired renal function (serum creatinine >150 µmol/l). 9. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit). 10. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months. 11. Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg. 12. Any condition that the investigator feels would interfere with trial participation. 13. Receiving any experimental or pre-marketing drug within the last 3 months. 14. Use of diabetes medication or weight-lowering pharmacotherapy within the preceding 3 months. 15. Known type 1 diabetes. 16. Suicidal behavior as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (except DXA scanning visits, please see Table 1) possible suicidality will be evaluated according to the guidelines. If the patient is evaluated as suicidal, the person will be excluded from the study and evaluated by a senior consultant in psychiatry, who will take further action. 17. Plasma HbA1c > 57 mmol/mol (tested twice) in which case the patient will be excluded from the study and transferred to general practitioner or hospital for diabetic treatment. No diabetic medication is allowed except for the trial medicine. 18. Any known contraindication towards the treatment with semaglutide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate long term (26 weeks) effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with a diagnose of schizophrenia, aged 18 years to 65 years who have initiated treatment with clozapine or olanzapine.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c). ;Timepoint(s) of evaluation of this end point: Glycaemic control is evaluated by the level of HbA1c on the day of inclusion (basal level) and after 26 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include changes in body weight, hip and waist circumference, blood pressure, heart rate and plasma concentrations of insulin, C-peptide, glucagon and incretin hormones as well as plasma levels of glucose. Additionally, lipid profile, proteomics and bone markers will be evaluated in the fasting state. Insulin sensitivity and beta-cell function (evaluated by homeostatic model assessment (HOMA)). Additional endpoints include: body composition and bone density (evaluated by DXA-scanning), liver function (transaminases), liver fibrosis (fibrosis-4 (FIB-4) score), alcohol, tobacco and drug use, preference for sweet and fatty candy, psychopathology, activity and quality of life. In addition, blood samples for proteomic analyses and urine samples for measurement of oxidative stress will be collected. For patients enrolled in the study, all endpoints will initially be collected and several repeated during full study duration.;Timepoint(s) of evaluation of this end point: All secondary endpoints will initially be collected and several repeated during full study duration. | — |
Countries
Denmark
Contacts
Public ContactMette Kruse Klausen
Psychiatric Centre Copenhagen
Outcome results
None listed