Severe Mental DisorderNCT06624462
Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
A study testing Treatment in the Meta Care Clinic in people with Severe Mental Disorder and Metabolic Complication, run by Bjorn H. Ebdrup at 1 site in Denmark.
Trial summary
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Severe Mental Disorder, Metabolic Complication, Side-Effect;Medication
- What is being tested?
- Treatment in the Meta Care Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
Glostrup Municipality, Capital Region, 2600
Bjorn H Ebdrup, MD, Consultant,PhD, Professor,, +4538640840, bebdrup@cnsr.dk
Grimur H Mohr, MD, +45 38 64 08 40, grimur.hoegnason.mohr@regionh.dk
About this study
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
Read the 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
- Being tested
- Treatment in the Meta Care Clinic, Standard care with general practitioner and/or outpatient clinics
- Keywords
- Severe mental illness, Overweight and obesity, Antipsychotic medication, Dysmetabolism, Schizophrenia Spectrum Disorders, Bipolar disorder
- Medical subject headings
- Mental Disorders, Drug-Related Side Effects and Adverse Reactions, Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar Disorder, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment in the Meta Care ClinicOther
- 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 clinicsOther
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 group | Role | What they receive |
|---|---|---|
| Treatment in the Meta Care Clinic | Active comparator | 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. Receives: Other: Treatment in the Meta Care Clinic |
| Standard care with general practitioner and/or outpatient clinics | Active comparator | 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. Receives: Other: Standard care with general practitioner and/or outpatient clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a weight loss of ≥5% of initial body weight.
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.
Measured: 12 months
Secondary outcomes (18)
The metabolic composite score
The metabolic composite score consisting of minimally 0 points and maximally five points (one point per composite; elevated waist circumference, elevated triglycerides, blood pressure, fasting plasma glucose, and reduced high-density lipoprotein), according to the definition and cut-off values of metabolic syndrome by the International Diabetes Federation. A higher score means worse outcomes. Effect measurements: differences in percentage achieving reduction of ≥1 points between groups at 12 months.
Measured: 12 months
Cardiovascular risk factors
Cardiovascular risk factors as defined below.
Measured: 12 months
Proportion of patients achieving a weight loss of ≥10% of initial body weight.
Proportion of patients in the intervention group achieving a weight loss of ≥10% of initial body weight vs the standard care group at 12 months.
Measured: 12 months
Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol
Proportion of patients in the intervention group achieving a ≥50% reduction of initial low-density lipoprotein cholesterol vs the standard care group at 12 months.
Measured: 12 months
Body weight
Absolute and relative changes in body weight. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Waist circumference
Absolute and relative changes in waist circumference. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Body mass index
Changes in body mass index (BMI) where weight and height will be combined to report BMI in kg/m^2. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Glucose
Fasting plasma glucose. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Insulin
Fasting Plasma insulin. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
The homeostatic Model Assessment for Insulin Resistance
The homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measured using fasting plasma glucose and fasting plasma insulin.
Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Total cholesterol
Fasting plasma total cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Low-density lipoprotein cholesterol
Fasting plasma Low-density lipoprotein (LDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
High-density lipoprotein cholesterol
Fasting plasma high-density lipoprotein (HDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Very Low-density lipoprotein cholesterol
Fasting plasma Very Low-density lipoprotein (VLDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Triglycerides
Fasting plasma triglycerides. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Heart rate
Resting heart rate. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Blood pressure
Clinic blood pressure. Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Hemoglobin A1c
Hemoglobin A1c (HbA1c). Effect measurements: differences in mean changes between groups at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start10 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, open label, non-blinded randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bjorn H. Ebdrup
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, University of Toronto, Herlev and Gentofte Hospital
- Responsible party
- Sponsor-investigator, Bjorn H. Ebdrup, University of Copenhagen
- Investigators
- Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,, Study chair, Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624462
- Sponsor's protocol ID
- The Meta Care Clinic
- Other IDs
- H-23045618, p-2023-14342, 2096-00099B
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated deidentified data is expected to be available after publication upon request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
- ClinicalTrials.gov ID
- NCT06624462
- Acronym / sponsor ID
- The Meta Care Clinic
- Conditions
- Severe Mental Disorder, Metabolic Complication, Side-Effect;Medication, Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar Disorder
- Keywords
- Severe mental illness, Overweight and obesity, Antipsychotic medication, Dysmetabolism, Schizophrenia Spectrum Disorders, Bipolar disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Bjorn H. EbdrupUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, University of Toronto, Herlev and Gentofte Hospital
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic, open label, non-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment in the Meta Care Clinic | Active comparator | Other: Treatment in the Meta Care ClinicThe 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. |
| Standard care with general practitioner and/or outpatient clinics | Active comparator | Other: Standard care with general practitioner and/or outpatient clinicsThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Treatment in the Meta Care Clinic |
| Standard care with general practitioner and/or outpatient clinicsFollowing 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. | Other | Standard care with general practitioner and/or outpatient clinics |
Primary outcome
Proportion of patients achieving a weight loss of ≥5% of initial body weight.
Time frame: 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.
18 secondary outcomes
The metabolic composite score
Time frame: 12 months
Cardiovascular risk factors
Time frame: 12 months
Proportion of patients achieving a weight loss of ≥10% of initial body weight.
Time frame: 12 months
Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol
Time frame: 12 months
Body weight
Time frame: 12 months
Waist circumference
Time frame: 12 months
Body mass index
Time frame: 12 months
Glucose
Time frame: 12 months
Insulin
Time frame: 12 months
The homeostatic Model Assessment for Insulin Resistance
Time frame: 12 months
Total cholesterol
Time frame: 12 months
Low-density lipoprotein cholesterol
Time frame: 12 months
High-density lipoprotein cholesterol
Time frame: 12 months
Very Low-density lipoprotein cholesterol
Time frame: 12 months
Triglycerides
Time frame: 12 months
Heart rate
Time frame: 12 months
Blood pressure
Time frame: 12 months
Hemoglobin A1c
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Yes. Aggregated deidentified data is expected to be available after publication upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bjorn H. Ebdrup, MD, Consultant,PhD, Professor, study chair
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in the Meta Care Clinic in people with Severe Mental Disorder and Metabolic Complication, run by Bjorn H. Ebdrup at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bjorn H. Ebdrup, MD, Consultant,PhD, Professor, (+4538640840, bjoern.ebdrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving a weight loss of ≥5% of initial body weight. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.