Now enrolling: Clinical trial for negative symptoms of schizophrenia
You may be eligible to take part in medical research
By participating in the study you or your loved one may receive*:
- Study-related care at no cost
- Access to digital apps that are under development to see if they can help with moderate to severe negative schizophrenia symptoms
- Up to $1,000
- About the CONVOKE Study
What is the CONVOKE Study?
Are you or your loved one taking antipsychotic medication but still feeling no motivation, desire to socialize, or interest in the things that you used to enjoy? We invite you or your loved one to take part in the CONVOKE clinical research study testing mobile applications designed to help with these symptoms and bring joy into your life.
The CONVOKE Study is a clinical research study, also called a clinical trial. The study will look at 2 mobile applications (apps) under development to see if they can treat people with moderate to severe negative schizophrenia symptoms. Negative symptoms may include feeling no motivation, desire to socialize, or interest in the things that you used to enjoy.
These apps are prescription digital therapeutics (PDTs) under development that are downloaded onto your smartphone. This study will see if an app can be part of a schizophrenia treatment plan. People taking part in the study can continue taking existing medications. No additional medications are required. The results of this study could help other people who experience negative symptoms of schizophrenia.
In this study, you will be placed randomly into 1 of 2 groups. Each group will use a different app. The study is blinded, which means that the study doctor cannot know which app you are using.
In our communication, we use the term “study app” to talk about both apps.
The study will last for about 22 weeks, and will include 4 study center visits for assessments and 3 telephone calls. After the main study, you may be offered an option to take part in a 20-week extension study.
What to expect
If you are eligible to take part, and decide to do so, you will need to visit the study center 4 times for study assessments. There will also be 3 times when you will speak by telephone to the study team.
Several tests and assessments will be performed to see if you qualify for the study, and to monitor treatment effectiveness. These will include:
- Questionnaires with the study doctor about your health conditions
- Urine tests to check for drugs or medications
- Pregnancy tests
The study periods
The CONVOKE Study is split into 3 periods: screening, study treatment, and follow-up.
Screening:
The screening will take up to 2 weeks. You will visit the study center to see if the study is right for you and if you want to take part.
Study treatment:
The study treatment period will last about 16 weeks. It will include 3 study center visits and 2 phone calls. You also will use the study app daily. The study app will stop working when you complete the study treatment period. You will not be able to use it anymore, but you will still be able to access previous app content during the follow-up period.
Follow-up:
The follow up period will include 1 telephone call.
- Who can take part?
To qualify for the CONVOKE Study a person needs to:
- Be at least 18 years of age
- Own a smartphone (Android OS 10 or greater)
- Have a primary diagnosis of schizophrenia
- Be on a stable dose of antipsychotic medication
- Be fluent in written and spoken English and able to understand the Informed Consent Form (ICF)
- Be located in the U.S. for the duration of the study
You must meet all other study criteria to take part in the CONVOKE Study.
- Frequently asked questions (FAQs)
What is a clinical research study?
This clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of a study application (app) called a prescription digital therapeutic under development. Doctors and researchers conduct clinical research studies. A clinical research study helps to answer important questions about the study app, such as:
● How safe is it?
● Does it work?
Clinical research studies must test digital therapeutics before they can be authorized and prescribed for use. For new digital therapeutics to be prescribed for patients, we need participants willing to test them.
I’ve read all the information on this website, and I still have questions about trying an app that may not work for my schizophrenia. Can you give me more information?
There are always risks and benefits of participating in a clinical research study. There is always a chance that the study app being tested could not work. However, there are strict rules in place to monitor the safety of people taking part in the study. Before joining any clinical research study, it is important to consider the risks and understand what they are. The study team will explain the risks and benefits to you at the first study visit. Throughout the study, you will be closely monitored by a team of local doctors and nurses. They will be there to answer any questions you may have.
Is there a cost to take part?
You will receive the study app at no cost to you. You will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.
Will my confidentiality be protected?
Personal information will remain confidential, and data will only be collected and used as is necessary to support your match to and participation in a study. Your name will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.
Are clinical research studies safe?
Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are the highest priority of any study.
Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an Informed Consent Form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.
What else do I need to think about?
It is up to you to decide if you want to take part in the CONVOKE Study. Taking part in the study is voluntary. Please also consider:
● If you decide to take part, you can stop at any time during the study.
● The study team will explain the possible benefits and risks of the study during the informed consent process.
● A team of doctors and nurses will monitor your health carefully during the study.
● The study app will be provided at no cost.
● If you decide to participate, you may help people with the treatment of schizophrenia in the future.
You will need to follow all the instructions from the study doctor and nurses.
This website is intended for residents of the USA only
*In this clinical research study, participants may receive an investigational device that has not been approved by regulatory authorities, or an approved comparator product, or an intervention. You may not benefit from the study intervention you are assigned to. The key known risks and requirements of participation in the study will be described to you before you decide whether to take part. In this study, compensation will be available as well as reasonable reimbursement for travel expenses.