Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Launched by BJORN H. EBDRUP · Sep 30, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
The Meta Care Clinic trial is studying how effective a special clinic can be for helping patients with severe mental illnesses, such as schizophrenia and bipolar disorder, who also have metabolic issues like obesity or high blood pressure. This clinic aims to provide care that addresses both mental health and physical health problems caused by medications. The trial is currently looking for participants aged 18 to 45 who are being treated with antipsychotic medications and have specific weight or metabolic health concerns.
Eligible participants might have a body mass index (BMI) that is considered overweight or have a history of gaining weight rapidly while on medication. If you join the study, you can expect to receive support and treatment from healthcare professionals who are trained to help with both your mental and physical health. It's important to know that the trial will not accept individuals with severe substance abuse issues or those who are at immediate risk of harming themselves. This study could provide valuable insights into improving care for people facing these challenges.
Gender
ALL
Eligibility criteria
- 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.
About Bjorn H. Ebdrup
Bjorn H. Ebdrupe is a dedicated clinical trial sponsor with a focus on advancing innovative therapeutic solutions through rigorous research and development. With a commitment to enhancing patient outcomes, Ebdrupe oversees a portfolio of clinical trials designed to evaluate the safety and efficacy of novel treatments across various therapeutic areas. Leveraging a collaborative approach, Ebdrupe engages with leading researchers, healthcare professionals, and regulatory bodies to ensure the highest standards of compliance and scientific integrity. Their mission is to bridge the gap between cutting-edge science and clinical practice, ultimately contributing to the betterment of global health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Glostrup, Capital Region, Denmark
Patients applied
Trial Officials
Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,
Study Chair
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported