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 research study is investigating a new medication, Valbenazine, for individuals who have schizophrenia. The main goal is to find out if taking Valbenazine alongside their current treatments can help to lessen schizophrenia symptoms and improve how well people manage their daily activities. This is a Phase 3 study, meaning it's a larger trial to confirm if the treatment is safe and effective before it can be considered for general use. Participants will be randomly given either Valbenazine or a dummy pill (placebo) for 10 weeks. Neither the patient nor their doctor will know which one they are receiving. Researchers will be looking for changes in symptoms and overall well-being during this period to understand if Valbenazine makes a positive difference.
At a glance
What is this study about?
This research study is looking into a new medication called Valbenazine for people living with schizophrenia. Schizophrenia is a long-term condition that can affect how a person thinks, feels, and behaves. Current treatments aim to help manage symptoms, but sometimes more support is needed.
The main purpose of this study is to see if adding Valbenazine to the treatments people are already taking can help reduce their symptoms of schizophrenia and improve their daily lives. Researchers want to know if Valbenazine is both effective and safe. They will compare it to a dummy pill (called a placebo) to understand its true effects. This is a "Phase 3" study, which means it's one of the final steps in testing a new medicine before it can be considered for wider use.
Throughout the study, researchers will carefully monitor participants. The main way they'll measure how well Valbenazine is working is by looking at changes in schizophrenia symptoms from the start of the study to 10 weeks later. They will also assess how well people are managing their day-to-day activities and their general overall health. The goal is to see if Valbenazine can offer a meaningful improvement for people with schizophrenia.
Key takeaways
- This study is testing a new medicine, Valbenazine, for schizophrenia.
- It aims to see if Valbenazine helps reduce symptoms and improve daily life.
- Participants will receive either Valbenazine or a dummy pill for 10 weeks.
- You will continue your existing schizophrenia medication.
- The study involves regular clinic visits for health checks and symptom monitoring.
Who may be eligible?
To take part in this study, you need to be an adult, aged 18 or older. Both men and women can participate. The study is specifically for people who have been diagnosed with schizophrenia.
More detailed checks will be done by the study team, but generally, you would need to be in a stable condition and might need to be on a consistent dose of any other medications you are taking for schizophrenia before joining.
There might be certain other health conditions or medications that would prevent someone from joining, as these could affect the study results or your safety. Your doctor and the study team will go through all the requirements with you to make sure it's safe and appropriate 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.
- Are you 18 years old or older?
- Have you been diagnosed with schizophrenia?
- Are you able to attend regular clinic appointments?
- Are you currently receiving treatment for schizophrenia?
What does participation involve?
If you decide to take part, you'll be randomly assigned to either receive the new medicine, Valbenazine, or a dummy pill (placebo). Neither you nor your study doctor will know which one you are receiving – this is called 'double-blind' and helps ensure fair results. You will continue to take your regular schizophrenia medication as prescribed.
Participation will involve regular visits to the study clinic over a period of 10 weeks. During these visits, the study team will: perform health checks, measure your symptoms using specific questionnaires and scales (like the PANSS score), check how you are managing your daily activities, and monitor for any side effects. You might also have blood tests. After the 10-week treatment period, there will likely be follow-up appointments to ensure your well-being. The total duration of your involvement, including all follow-ups, will be explained in detail.
Potential risks and benefits
Locations (6)
- —UnverifiedBulgaria
- —UnverifiedCroatia
- —UnverifiedCzechia
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedSlovakia
Common questions
What is Valbenazine?
Valbenazine is a new investigational medicine being tested to see if it can help reduce symptoms for people with schizophrenia.
What is a 'dummy pill' (placebo)?
A dummy pill looks just like the study medicine but contains no active drug. It helps researchers understand the true effects of the medicine.
How long will the study last?
The main treatment part of the study will last for 10 weeks, with additional follow-up visits after that.
Will I still take my regular medication?
Yes, this study looks at adding Valbenazine to your existing schizophrenia treatments, so you will continue to take your prescribed medicines.
Can I choose not to take part?
Yes, participation is completely voluntary, and you can decide not to join or to leave the study at any time without it affecting your 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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