Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic

NCT06624462 · tracked via the Priya Life Science Denmark tracker

Sponsor

Bjorn H. Ebdrup

Phase

Not applicable

Started

2023-10-10

Last updated

2026-01-08

Condition(s) studied

Severe Mental DisorderMetabolic ComplicationSide-Effect;MedicationSchizophrenia Spectrum and Other Psychotic DisordersBipolar Disorder

Investigational drug(s) / intervention(s)

Treatment in the Meta Care ClinicStandard care with general practitioner and/or outpatient clinics

Treatment in the Meta Care Clinic: * Consultations by medical doctors with specific metabolic training from the metabolic clinic located at Centre for Addiction and Mental Health in Toronto, Canada, and an exercise physiologist. * Evaluation of their psychopharmacotherapy with consultation and detailed recommendations to the patients' treating psychiatrist and/or general practitioner regarding dosage reductions or switching of psychotropics if this is clinically feasible to reduce the metabolic burden. * Lifestyle interventions * Pharmacotherapy with evidence to support use to mitigate antipsychotic-induced weight gain * Treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and diabetes in close collaboration with recognized specialists in endocrinology. * Assessment of plans at conferences with participation of the sponsor, the primary investigator as well as recognized specialists in endocrinology and psychiatry. * Qualitative interviews will be conducted post-intervention.

Standard care with general practitioner and/or outpatient clinics: Following measurements after 12 months, patients will receive individualized lifestyle recommendations from an exercise physiologist and a MD will offer to send recommendations regarding the following potential post-trial interventions to the patients' general practitioner and/or outpatient clinic prepared in close collaboration with recognized specialists in psychiatry and endocrinology: * Suggestions regarding relevant psychotropic medication adjustments or switches if this is found relevant and clinically feasible to reduce the metabolic burden. * Suggestions regarding potential add-on of weight reducing pharmacotherapy. * Suggestions regarding pharmacological treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and type 2 diabetes.

Study summary

This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness

Eligibility

Sex

ALL

Min age

18 Years

Max age

45 Years

Healthy volunteers

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.

Primary outcome measure(s)

Proportion of patients achieving a weight loss of ≥5% of initial body weight. — 12 months
Proportion of patients in the intervention group achieving a weight loss of ≥5% of initial body weight vs the standard care group at 12 months.

Trial sites (1)

Facility	City	Region	Status
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup	Glostrup Municipality	Capital Region	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06624462 on ClinicalTrials.gov ↗ ← All trials in Denmark