Metabolic care for patients with severe mental illness
Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
This study is testing a special clinic for people with severe mental illness to see if it helps them manage weight and heart health better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Glostrup Municipality, Capital Region) |
| Trial ID | NCT06624462 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of a specialized metabolic care clinic designed for patients with severe mental illness, particularly those diagnosed with schizophrenia spectrum disorders or bipolar disorder. The clinic aims to address the cardiometabolic risks associated with antipsychotic medications, such as obesity and dysmetabolism, which are often undertreated. A total of 80 patients aged 18-45 will be enrolled and randomly assigned to either the metabolic care clinic or standard care, with a focus on measuring patient outcomes and satisfaction. The study also includes qualitative assessments of patient perspectives on care and motivation for health behavior change.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 with schizophrenia spectrum disorders or bipolar disorder who are receiving antipsychotic treatment and have specific metabolic concerns.
Not a fit: Patients who do not have a diagnosis of schizophrenia spectrum disorders or bipolar disorder, or those who are not on antipsychotic medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the metabolic health and overall well-being of patients with severe mental illness.
How similar studies have performed: While there is ongoing research in metabolic care for mental health patients, this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Glostrup Municipality, Capital Region
- Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup — Glostrup Municipality, Capital Region, Denmark (Recruiting)
Study contacts
- Study coordinator: Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,
- Email: bjoern.ebdrup@regionh.dk
- Phone: +4538640840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.