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New clinic aims to tackle weight gain in mental health patients

NCT ID NCT06624462

Disease control Sponsor: Bjorn H. Ebdrup Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special clinic designed to help people with severe mental illness (like schizophrenia or bipolar disorder) lose weight and improve their metabolic health. About 84 participants will either receive care at this clinic or standard care for 12 months. The main goal is to see if more people in the clinic group lose at least 5% of their starting body weight.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bipolar disorder Drug-Related Side Effects and Adverse Reactions mental disorder metabolic disease Obesity Overweight psychiatric disorder psychotic disorder schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder Metabolic complication Schizophrenia spectrum and other psychotic disorders Severe mental disorder Side-effect;medication

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Glostrup Municipality, Capital Region, 2600, Denmark

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