💬In plain words
What the trial is, and whether it could suit you
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)
* Medical treatment with antipsychotics
* Age 18-45 years
* Legally competent
* Able to give informed consent
and either:
\- Body mass index (BMI) ≥30 kg/m2.
Or
* BMI ≥27 kg/m2 and at least one of the following:
* Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office / 24-hour, non-invasive ambulatory blood pressure ≥140/90 mmHg within the previous 6 months
* Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol/l), elevated triglycerides (≥1.7 mmol/l) or low high-density lipoprotein cholesterol (≥1.2 mmol/l in women and ≥1.0 mmol/l in men) within the previous 6 months
* Sleep apnoea (ICD-10 DG473).
* Prediabetes or diabetes defined as HbA1c ≥42 mmol/mol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.
Or
\- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.
Exclusion Criteria:
* Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.
* Unstable psychiatric disorder as judged by the research team.
* Severe current drug or alcohol misuse as judged by the research team.
* Acute suicidal risk.
💊
What it tests
- Treatment in the Meta Care Clinic
- Standard care with general practitioner and/or outpatient clinics
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
Glostrup Municipality, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.