A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia
This study is looking into a new medicine called Valbenazine for people with schizophrenia. It's a 'Phase 3' study, which means it's one of the final steps before a medicine might become widely available. Participants will be randomly given either Valbenazine or a dummy pill (placebo) alongside their usual treatments. The main goal is to find out if Valbenazine improves symptoms of schizophrenia over a 10-week period. Researchers will also check how safe the medicine is and if people have any side effects. This is a common and important way to test new medicines to make sure they are effective and safe for patients.
At a glance
What is this study about?
This research study is about a new medicine called Valbenazine. Doctors are trying to find out if this medicine can help people who have schizophrenia. Schizophrenia is a long-term mental health condition that can cause a range of different psychological symptoms, such as hallucinations, delusions, and confused thoughts. People with schizophrenia often take other medicines to help manage their symptoms.
In this study, researchers want to see if adding Valbenazine to a person's existing schizophrenia treatment can make a difference. They'll be looking closely at changes in symptoms over about 10 weeks. They will also carefully check for any side effects and how well people tolerate the medicine. This is a very important step to understand if Valbenazine could be a useful new option for people living with schizophrenia.
This kind of study is called a 'Phase 3' study. This means it's a large and advanced study, often one of the last stages before a new medicine is considered for general use. The aim is to get a very clear picture of how effective and safe Valbenazine is when used for schizophrenia.
Key takeaways
- This study is testing a new medicine, Valbenazine, for schizophrenia.
- It aims to see if Valbenazine improves symptoms when added to existing treatment.
- Participation involves taking medication and attending regular check-ups for about 10 weeks.
- People in the study will get either Valbenazine or a dummy pill.
- All participants receive close medical monitoring.
- You can leave the study at any time without affecting your care.
Who may be eligible?
To join this study, you would need to be at least 18 years old. Both men and women are welcome to take part. Researchers are looking for people who have been diagnosed with schizophrenia to see if the new medicine can help them.
There might be other specific health requirements or conditions that mean you can or cannot join. For example, if you have certain other medical problems or are taking particular medicines, you might not be able to participate. This is to make sure the study is safe for everyone involved and that the results are clear.
If you're interested, the study team would have a detailed chat with you about your health history to see if the study is a good fit for you. They will explain everything clearly and answer any questions you have.
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.
- Are you 18 years or older?
- Do you have a diagnosis of schizophrenia?
- Are you currently receiving treatment for schizophrenia?
- Are you generally able to attend regular appointments for about 10 weeks?
- Are you willing to potentially receive a dummy pill instead of the study drug?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine, Valbenazine, or a dummy pill (placebo) on top of your current schizophrenia treatment. You wouldn't know which one you're getting, and neither would your study doctor – this is to make the results as fair as possible.
You would have regular visits to the study clinic over a period of about 10 weeks. During these visits, you would talk to the study doctor and nurses about your symptoms, how you're feeling, and any side effects you might be experiencing. They would likely do some straightforward assessments to measure any changes in your symptoms.
Your participation would involve taking the study medication as instructed and attending all your scheduled appointments. The total duration of active participation in the study, where you are taking medication and having assessments, would be around 10 weeks.
Potential risks and benefits
Locations (6)
- —UnverifiedRomania
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedSlovakia
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
What is the new medicine being tested?
The new medicine is called Valbenazine. It's being tested alongside usual treatments for schizophrenia.
What is a 'dummy pill'?
A dummy pill, or placebo, looks just like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.
How long will the study last for me?
The main part of the study, where you take medication and have check-ups, will last about 10 weeks.
Will I still take my regular medication?
Yes, this study is testing Valbenazine as an added treatment, so you would continue to take your current schizophrenia medicines.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point, and it won't affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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