An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR

Conditions

Metabolic control in antipsychotic-using patients

Brief summary

The primary endpoints addressing the primary objective: change in body weight from baseline to week 26 of the study

Detailed description

Change from baseline at week 0 to week 26 in: o HbA1c (%, mmol /mol) o FPG (mmol/l) o Fasting serum insulin (mIU/L) and insulin C peptid o Lipids (mg/dL)  Total cholesterol  High density lipoprotein (HDL) cholesterol  Low density lipoprotein (LDL) cholesterol  Very low density lipoprotein (VLDL) cholesterol  Free fatty acids  Triglycerides, Change from baseline at week 0 to week 26 in cognition as assessed by the Brief Assessment of Cognition in Schizophrenia (BACS), Time (in days) until discontinuation of AP drug treatment as evaluated through interviews and the measurement of serum levels of antipsychotic drugs, Change from baseline at week 0 to week 26 in the Stunkard scale, The economic outcomes will be assessed in the following way: Analysis of incremental cost-effectiveness ratio (ICER) and a cost-utility analysis based on an well-validated instrument to capture changes in quality of life during the intervention period. These outcomes will also use register-data collected during the 12 months after participation in the RCT. Change in quality of life from baseline at week 0 to week 26 will be assessed by the Manchester Short Assesment of quality of life (MANSA)., Change from baseline at week 0 to week 26 for waist and hip circumference, waist to hip ratio, Change from baseline at week 0 to week 26 in heart rate and blood pressure after 5 minutes at rest, Proportion of participants with T2DM at week 26, Change from baseline at week 0 to week 26 in the ratings of the Calgary Depression Scale for Schizophrenia (CDSS)

Related papers

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Interventions

DRUGPlacebo matching active treatment.

DRUGWegovy 2.4 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoints addressing the primary objective: change in body weight from baseline to week 26 of the study	—

Secondary

Measure	Time frame
Change from baseline at week 0 to week 26 in: o HbA1c (%, mmol /mol) o FPG (mmol/l) o Fasting serum insulin (mIU/L) and insulin C peptid o Lipids (mg/dL)  Total cholesterol  High density lipoprotein (HDL) cholesterol  Low density lipoprotein (LDL) cholesterol  Very low density lipoprotein (VLDL) cholesterol  Free fatty acids  Triglycerides, Change from baseline at week 0 to week 26 in cognition as assessed by the Brief Assessment of Cognition in Schizophrenia (BACS), Time (in days) until discontinuation of AP drug treatment as evaluated through interviews and the measurement of serum levels of antipsychotic drugs, Change from baseline at week 0 to week 26 in the Stunkard scale, The economic outcomes will be assessed in the following way: Analysis of incremental cost-effectiveness ratio (ICER) and a cost-utility analysis based on an well-validated instrument to capture changes in quality of life during the intervention period. These outcomes will also use register-data collected d	—

Measure

Time frame

Change from baseline at week 0 to week 26 in: o HbA1c (%, mmol /mol) o FPG (mmol/l) o Fasting serum insulin (mIU/L) and insulin C peptid o Lipids (mg/dL)  Total cholesterol  High density lipoprotein (HDL) cholesterol  Low density lipoprotein (LDL) cholesterol  Very low density lipoprotein (VLDL) cholesterol  Free fatty acids  Triglycerides, Change from baseline at week 0 to week 26 in cognition as assessed by the Brief Assessment of Cognition in Schizophrenia (BACS), Time (in days) until discontinuation of AP drug treatment as evaluated through interviews and the measurement of serum levels of antipsychotic drugs, Change from baseline at week 0 to week 26 in the Stunkard scale, The economic outcomes will be assessed in the following way: Analysis of incremental cost-effectiveness ratio (ICER) and a cost-utility analysis based on an well-validated instrument to capture changes in quality of life during the intervention period. These outcomes will also use register-data collected d

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Countries

Norway

Outcome results

None listed

An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study)