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Tests treatment safety and results for Severe Mental Disorder
Official title Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
ClinicalTrials.gov ID: NCT06624462
What this study is testing
- What it's testing
- This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup Municipality, Capital Region, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup Municipality, Capital Region, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.