RecruitingPHASE4INTERVENTIONAL

The Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

This study, called INTENSIFY-Schizophrenia, is for people with schizophrenia or similar conditions who haven't found their first medication helpful. We're trying to find out if starting a medicine called clozapine earlier works better than continuing with other standard treatments. Clozapine is already known to be effective for some, but it's usually only given after other treatments haven't worked. This research wants to see if giving it sooner can help people more, potentially preventing longer periods of illness and hospital stays. It's an important step towards finding the best individual treatment for people who might be harder to treat.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Dr. Inge Winter

Enrolment target

418

Start

01 Aug 2024

Estimated completion

30 Jun 2028

Schizophrenia and Related Disorders Early Treatment-Resistance

What is this study about?

Many people live with schizophrenia, a condition that can significantly affect daily life through things like frequent relapses, difficulty keeping a job, or simply not feeling well. When someone is diagnosed, they usually start with an antipsychotic medication. However, for about one-third of people, these first treatments don't work as well as hoped. This can be very frustrating and lead to ongoing problems.

Currently, if initial treatments aren't effective, doctors typically try other standard medications. If these also don't work, a medication called clozapine is often considered. Clozapine is known to be very effective for many people with schizophrenia, even those who haven't responded to other treatments. While it has some side effects that mean patients need close monitoring, doctors often feel the benefits outweigh these risks, especially for those who haven't improved with other medicines.

This study asks a really important question: What if we started clozapine earlier, for people who haven't responded to their very first treatment? Could this help them get better sooner, prevent unnecessary hospital stays, and improve their quality of life? The INTENSIFY-Schizophrenia trial is investigating if this 'earlier and more focused' treatment approach is better than the usual way of trying several different medications one after another. The hope is to find better ways to decide which treatments are best for each person, especially for those whose condition might be harder to manage.

Key takeaways

Tests if an existing medication (clozapine) works better when started earlier for schizophrenia.
Aims to help people whose first treatment hasn't been effective.
Compares early clozapine to current standard treatments.
Could lead to better, more tailored treatment choices for individuals.
The study lasts six weeks and involves close monitoring.
You can choose to leave the study at any time.

Who may be eligible?

This study is looking for volunteers aged between 18 and 70. You might be able to take part if you have a diagnosis of schizophrenia or a related condition like schizoaffective disorder, and your current treatment hasn't been effective. This means you're still experiencing symptoms, and your doctor thinks it's time to try a different medication.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have previously taken clozapine. Also, if you have allergies to clozapine or to the other standard medications used in the study, or if you have certain medical conditions that mean clozapine or these other medications wouldn't be safe for you, then you wouldn't be eligible. Each potential participant will have a thorough check-up to make sure the study is a safe option for them.

Quick self-check

Are you between 18 and 70 years old?
Do you have a diagnosis of schizophrenia or a similar condition?
Has your current medication for schizophrenia not been effective?
Are you not pregnant or breastfeeding?
Have you never taken clozapine before?
Are you willing and able to give your permission to join the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, your treatment will be carefully monitored for six weeks. You will either receive clozapine (an established medication) or continue with other standard antipsychotic medications, depending on which group you're assigned to by chance. You will have regular visits with the study team, likely including appointments where your symptoms and how you are feeling will be assessed. These assessments help the researchers understand how well the treatments are working. You'll also have blood tests and other health checks to make sure the medication is safe for you. The study aims to look at the short-term effects over six weeks, but the exact number of visits and tests will be explained in detail before you decide to take part. After the six weeks, your doctor will discuss your ongoing treatment plan.

Potential risks and benefits

One potential benefit of taking part is that you might receive a treatment that works better for you, potentially leading to fewer symptoms and an improved quality of life. The study aims to find more effective ways to help people whose first treatment for schizophrenia hasn't worked. However, as with any medication, there are potential risks, including side effects from clozapine or standard antipsychotics. Clozapine, in particular, requires careful monitoring due to a small risk of serious side effects, mainly affecting blood cells. The study team will provide full details of all potential risks and side effects, and you'll be closely monitored throughout. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Medical University Innsbruck
Innsbruck, Austria· Recruiting
Bezirkskliniken Schwaben, Bezirkskrankenhaus Augsburg
Augsburg, Germany· Not yet recruiting
Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld
Bielefeld, Germany· Recruiting
LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft
Dortmund, Germany· Recruiting
University Hospital Frankfurt am Main - Goethe University
Frankfurt am Main, Germany· Recruiting
Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz
Mainz, Germany· Recruiting
Westfälische Wilhelms-Universität Münster
Münster, Germany· Recruiting
Universita degli Studi di Brescia
Brescia, Italy· Recruiting
University of Cagliari
Cagliari, Italy· Recruiting
Università degli studi della Campania Luigi Vanvitelli
Naples, Italy· Recruiting
Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
Turin, Italy· Recruiting
Fundació Clínic per a la Recerca Biomèdica
Barcelona, Spain· Recruiting

+1 more sites — see the official record for the full list.

Common questions

What is schizophrenia?

Schizophrenia is a complex and long-lasting mental health condition that can make it difficult to tell the difference between what's real and what isn't, manage emotions, think clearly, and relate to others.

What is clozapine?

Clozapine is a specific type of medication used to treat schizophrenia, often when other treatments haven't been effective. It can be very helpful but requires regular blood tests.

What does 'treatment as usual' mean?

'Treatment as usual' refers to the standard medications and care that doctors typically prescribe for schizophrenia when a first treatment hasn't worked.

Why is this study important?

This study is important because it could help doctors understand if starting an effective medication like clozapine earlier can lead to better outcomes for people with schizophrenia, potentially preventing unnecessary suffering and hospital stays.

How long does the study last?

The main treatment period for this study is six weeks, during which your progress and health will be closely monitored by the study team.

How to find out more

Inge Winter, Dr.

i.winter@umcutrecht.nl +31875553227 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.