All studies
AuthorisedTherapeutic confirmatory (Phase III)Interventional

A prospective, randomized, and controlled study comparing two treatment strategies (Dose REduction of Antipsychotics vs. Maintenance treatment) in patients with schizophrenia spectrum disorder after Stratification based on patients’ psychotic PHENotype: a personalized medicine approach

This important study looks at how people with schizophrenia spectrum disorders can best manage their condition. Researchers are comparing two treatment approaches over two years: continuing with their current antipsychotic medication at the usual dose, or slowly reducing the dose of their medication. The main aim is to find out which method helps people function better in their daily lives, like managing personal care, work, and social activities. This is measured using a special scale. The study wants to see if a more personalised approach, based on a person’s specific needs, can lead to better long-term results. Participants will be carefully monitored throughout the study.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Les Hopitaux Universitaires De Strasbourg
Enrolment target
288
Start
12 May 2025

What is this study about?

This study is called 'Dose REduction of Antipsychotics vs. Maintenance treatment', but we can think of it as looking at how to best manage schizophrenia spectrum disorders. These are conditions that affect how a person thinks, feels, and behaves, and they include schizophrenia, schizophreniform disorder, schizoaffective disorder, and brief psychotic episode. The study is trying to understand if carefully reducing medication, or staying on the usual dose, works better for people in the long run.

Researchers want to see if a more tailored approach to treatment, sometimes called 'personalised medicine', can lead to better outcomes. They will be looking closely at how well people are able to live their lives, their symptoms, and any relapses they might have over a two-year period. This includes checking things like how they get on with daily tasks, social activities, and work or studies. They hope to learn which method helps people live their lives to the fullest and avoid problems.

This is a 'Phase III' study, which means it's a very important step in testing new treatments. It involves a larger number of patients and compares a new approach (dose reduction) with a standard approach (usual dose). The results from this kind of study can help doctors decide on the best ways to treat people with these conditions in the future.

Key takeaways

  • This study compares two ways to manage schizophrenia spectrum disorders: usual medication dose vs. carefully reduced dose.
  • The main goal is to find out which approach helps people live better, more functional lives.
  • It lasts for two years, with regular check-ups and assessments.
  • A personalised approach to treatment is being explored.
  • Your daily functioning in life will be a key part of the assessment.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. People of any gender can take part.

You must have a diagnosis of a schizophrenia spectrum disorder. This includes conditions like schizophrenia, schizophreniform disorder, schizoaffective disorder, or a brief psychotic episode, as defined by standard medical guidelines.

More specific details about your health and medical history would be checked by the study team to make sure it's safe and suitable for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of a schizophrenia spectrum disorder (like schizophrenia, schizoaffective disorder, etc.)?
  3. Are you of any gender?
  4. Are you willing to potentially have your medication dose adjusted (if assigned to that group)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups: either you'll continue with your current antipsychotic medication at the usual dose, or your medication dose will be carefully and slowly reduced. The study will last for two years.

Throughout the study, you will have regular check-ups with your psychiatrist and the study team. These check-ups will involve discussions about how you're feeling, your daily activities, and any symptoms you might be experiencing. The main way they will measure your progress is by assessing a 'Personal and Social Performance Scale' score, which looks at how well you're managing in your daily life. This will happen during web meetings with you and your caregiver, and will focus on your functioning during the month before the meeting.

Your medication adherence will also be monitored, and you might be offered drug monitoring tests. There will also be a final interview with you and your caregiver at the end of the two years to look back at how things have gone.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring of your health and potentially finding a treatment approach that works better for you. However, there's always a risk that reducing medication might lead to a worsening of symptoms or a relapse for some individuals. The study team will monitor you closely for any changes. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is a schizophrenia spectrum disorder?

These are mental health conditions affecting how a person thinks, feels, and behaves, such as schizophrenia or schizoaffective disorder.

What kind of medications are being looked at?

The study is looking at various antipsychotic medications like Risperidone, Quetiapine, Olanzapine, and others you might already be taking.

How long will the study last?

If you join, you will be part of the study for two years.

Will I know if I'm reducing my medication or staying on the same dose?

Yes, you and your regular psychiatrist will know which treatment plan you are on. However, some of the people assessing your progress will not know.

What does 'functional remission' mean?

This means doing well in daily life, managing tasks, socialising, and feeling generally stable, as measured by a specific scale.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.