Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Recruiting now · Not applicable
Conditions studied: Severe Mental Disorder, Metabolic Complication, Side-Effect;Medication, Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar Disorder
In brief
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
Key facts
- Study ID
- NCT06624462
- Run by
- Bjorn H. Ebdrup
- People needed
- 84
- Starts
- 2023-10-10
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-08
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup — Glostrup Municipality, Capital Region, Denmark (enrolling)
Full record on ClinicalTrials.gov
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