Metabolic care for patients with severe mental illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines the effectiveness of a specialized metabolic care clinic designed for patients with severe mental illness, particularly those diagnosed with schizophrenia spectrum disorders or bipolar disorder. The clinic aims to address the cardiometabolic risks associated with antipsychotic medications, such as obesity and dysmetabolism, which are often undertreated. A total of 80 patients aged 18-45 will be enrolled and randomly assigned to either the metabolic care clinic or standard care, with a focus on measuring patient outcomes and satisfaction. The study also includes qualitative assessments of patient perspectives on care and motivation for health behavior change.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
  Glostrup Municipality, Capital Region, Denmark Recruiting

Study contacts

• Study coordinator: Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,
• Email: bjoern.ebdrup@regionh.dk
• Phone: +4538640840

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of comorbidity on people with severe mental illness

  This study tests how having both alcohol/substance use and a severe mental illness affects hospitalizations, medications, and social participation among adults followed at a mental health center.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07692984

• Venous Tourniquet with Low-Dose Sugammadex vs Arterial Tourniquet for Seizure Monitoring During ECT

  40 patients undergoing ECT will have a venous tourniquet on one arm and an arterial tourniquet on the other to see which method better reveals motor seizures.

  Recruiting Medipol University · Istanbul · NCT07534475

• 7T MRI and visual perception markers for severe mood and psychotic disorders

  This project tests whether 7‑tesla MRI scans combined with visual perception tests can identify brain markers linked to diagnosis and treatment outcomes in adults with major depressive disorder, bipolar disorder, or schizophrenia.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07479758

• Emotional Eating, Sleep Quality, Mental State, and Metabolic Syndrome in Psychiatric Patients

  This study tests how mood, sleep, and emotional eating relate to metabolic syndrome in people with schizophrenia or bipolar disorder.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07411222

• À deux, c'est mieux — group program to improve romantic relationships for young adults with severe mental illness

  This program will try a 12-week, small-group course to help single adults with severe mental illness build skills for dating, communication, and closer social relationships.

  Recruiting at 2 sites Centre hospitalier de Ville-Evrard, France · Épinay-sur-Seine, Île-de-France Region and 1 other locations · NCT07316803

• Brenipatide for adults with bipolar disorder (RENEW-Bipolar-1)

  This trial will test whether adding brenipatide to standard bipolar medications can delay worsening of symptoms in adults with bipolar I or II.

  Recruiting at 84 sites Phase 2 Eli Lilly and Company · Orange, California and 86 other locations · NCT07286175

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.