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

NCT ID: NCT06624462

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed Description

Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with high mortality rates and cardiovascular disease. Obesity and dysmetabolism caused by antipsychotic medication comprise modifiable risk factors, which remain undertreated.

The investigators will address the gaps in cardiometabolic care of SMI patients by examining the effectiveness of a pragmatic metabolic care clinic for patients with SMI. Moreover, the investigators will include qualitative investigation of patients' perspectives in relation to acceptability, satisfaction with care, and motivation for health behaviour change.

A total of 84 patients between 18-45 years with diagnoses of schizophrenia spectrum disorders or bipolar disorder will be recruited from inpatient and outpatient clinics in the Mental Health Services of the Capital Region of Denmark. Eligible patients are antipsychotics-treated and present with a 5% weight increase / 5 cm waistline increase since initiation of antipsychotic therapy or body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 and concomitant prediabetes, diabetes, hypertension, sleep apnoea and/or dyslipidaemia.

Patients will be enrolled in an open-label randomized controlled parallel-group trial with an allocation-ratio of 1:1 to a pragmatic, specialized metabolic clinic with measurement-based care and evidence-based best-practice treatment or standard care. The primary outcome is the proportion of patients in the intervention group achieving a weight loss ≥5% of initial body weight vs the standard care group at 12 months. Secondary and exploratory outcomes include changes in other cardiovascular risk factors, quality of life, personal recovery and cognitive measures. Finally, qualitative interviews will explore patient experience and contextual factors.

Conditions

Severe Mental Disorder; Metabolic Complication; Side-Effect;Medication; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment in the Meta Care Clinic

The patients who after randomization are allocated to the treatment arm will receive 12 months of treatment in a pragmatic metabolic clinic. Patients will receive measurements/monitoring at least 3 times during the study period: Upon enrolment, after 6 months and after 12 months.

Group Type: ACTIVE_COMPARATOR

Treatment in the Meta Care Clinic

Intervention Type: OTHER

• 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

The patients who after randomization are allocated for standard care will continue with their current psychiatric out-patient clinic and/or contact with their general practitioner. Patients will receive measurements/monitoring upon enrolment and after 12 months.

Group Type: ACTIVE_COMPARATOR

Standard care with general practitioner and/or outpatient clinics

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Centre Glostrup

UNKNOWN

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: collaborator

Bjorn H. Ebdrup

OTHER

Sponsor Role: lead

Responsible Party

Bjorn H. Ebdrup

MD, consultant, PhD and clinical professor in psychiatry Bjørn Hylsebeck Ebdrup

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,

Role: STUDY_CHAIR

Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen

Locations

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

Glostrup Municipality, Capital Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,

Role: CONTACT

bjoern.ebdrup@regionh.dk

+4538640840

Facility Contacts

Bjorn H Ebdrup, MD, Consultant,PhD, Professor,

Role: primary

bebdrup@cnsr.dk

+4538640840

Grimur H Mohr, MD

Role: backup

grimur.hoegnason.mohr@regionh.dk

+45 38 64 08 40

Other Identifiers

H-23045618

Identifier Type: OTHER

Identifier Source: secondary_id

p-2023-14342

Identifier Type: OTHER

Identifier Source: secondary_id

2096-00099B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

The Meta Care Clinic

Identifier Type: -

Identifier Source: org_study_id