RecruitingNot ApplicableNCT06624462

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


Sponsor

Bjorn H. Ebdrup

Enrollment

84 participants

Start Date

Oct 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a specialized metabolic care clinic — focused on physical health in people with serious mental illness — can effectively improve weight, blood pressure, cholesterol, and blood sugar in people taking antipsychotic medications. Antipsychotics can cause significant weight gain and metabolic problems over time. **You may be eligible if...** - You are between 18 and 45 years old - You have schizophrenia or bipolar disorder and are taking antipsychotic medication - You are legally competent and able to give consent - Your BMI is 30 or above; OR your BMI is 27 or above AND you also have at least one of: high blood pressure, high cholesterol, prediabetes/diabetes, or are taking weight-gain-associated antipsychotics **You may NOT be eligible if...** - You are outside the age range of 18–45 - You are not taking antipsychotics - You do not have the required BMI or metabolic risk factors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTreatment 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.

OTHERStandard 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.


Locations(1)

Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup

Glostrup Municipality, Capital Region, Denmark

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NCT06624462


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