Study investigating whether the drug semaglutide could be a safe and effective way of reducing metabolic problems, such as a high Body Mass Index (BMI) and high blood sugar levels, in people with psychosis.

Phase 4

Recruiting

• Conditions: Psychosis; Mental Health - Schizophrenia; Metabolic risk; Metabolic and Endocrine - Metabolic disorders; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12621001434886
• Lead Sponsor: South Eastern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-25
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

To be eligible for the study participants must:
•Be aged 18-65 years inclusive
•Be a client registered with SESLHD MHS with a documented psychotic illness
•Have a BMI > 25
•Have the ability to provide informed consent
•Currently be prescribed antipsychotic therapy (clozapine or olanzapine) and have been for at least 6 months.

Exclusion Criteria

Exclusion criteria for the study include people with the following conditions:
•A personal or family history of medullary thyroid cancer.
•Substance misuse or dependence except nicotine
•Impaired liver function as indicated by lfts > 2 times upper limit of normal
•Impaired pancreatic function as indicated by abdominal pain and a raised lipase, a history of pancreatitis or history of cancer of pancreas. Patients will be asked if they have abdominal pain. Patients with abdominal pain will be invited to have a blood lipase test irrespective of their participation in the trial. Those who consent and have a normal lipase will be included. Those who have an abnormal lipase will be excluded and referred to an emergency department
•Unstable angina or New York heart association (nyha) class iii or iv cardiac failure within the last 12 months
•Uncontrolled hypertension (sbp>180mm; dbp>110mm measured after 10 minutes rest)
•Any condition the investigators feel would interfere with study participation and completion
•Diabetes, including any person receiving insulin, sglt2 inhibitor or a gliptin or sulphonylurea. or who have HBA1c > 6.5 or fasting glucose >6.9mmol/L (and who therefore meet criteria for Type 2 Diabetes) will be excluded.
•Females who are pregnant or planning to become pregnant during the period of administration of the study medication
•Not maintained a stable weight (defined as a greater than 5% weight change since last weight one month earlier)

Or those currently receiving the following treatments:
•Any investigational drug within the last 3 months
•Pharmacotherapy for weight loss within the last 3 months
•Metformin (and not on a stable dose < 3 months)
•Oral medications requiring rapid gastro-intestinal absorption
•Hormone therapy with the exception of contraceptive hormones. Clients who are stable on thyroxine and without a history of thyroid cancer may be considered for the study.

Additionally potential participants will be excluded if their treating psychiatrist believes they may be unable to consent to participate in the trial, or who are vulnerable to suasion so that it is unlikely that informed consent can be properly obtained, or those who become so during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified