Frequently asked questions

What is the INTERACT study?

This study is an approximately 20-week clinical study of a new investigational medicine (known as TAK-831) for negative symptoms of schizophrenia. This phase 2 study will be evaluating how safe and how effective TAK-831 is when taken with standard medications, as well as seeing if it affects participants’ overall quality of life.

What are negative symptoms of schizophrenia?

Negative symptoms of schizophrenia are those that indicate an absence or decline of previously-present behaviors. Examples of negative symptoms include:

  • Reduced feelings of pleasure (anhedonia)
  • Emotionally-numb
  • Social withdrawal
  • Difficulty beginning and sustaining activity (avolition)
  • Decreased speaking and expressions

Negative symptoms can be harder for people with schizophrenia to notice compared to other types, but these symptoms can impact the quality of life for them and the people around them. There is currently no FDA approved medication for negative symptoms of schizophrenia.

What is a clinical study?

Clinical studies are one way that researchers deepen their understanding of diseases like schizophrenia. Clinical studies are a necessary step in determining if potential new medications are safe and effective. Before any potential medication can be widely used, the Food & Drug Administration (FDA) must review data from clinical trials and other scientific data about the medication before they can approve it for use. Clinical study data is a key component of this process. Clinical studies look to answer important questions about potential treatments, such as:

  • Does it work?
  • Does it lead to changes in people’s daily lives?
  • What is the best dose?
  • How safe is it?
  • Are there any side effects?

What are the potential benefits of participating in this study?

The effect of negative symptoms of schizophrenia on those living with it and those who care for them can be life-altering—and there’s currently no FDA approved medications available for the treatment of negative symptoms. This study is evaluating the efficacy and safety of an investigational medicine and participation allows people with these symptoms to contribute to research. If the condition does not improve, that is also important to further research.

Who is eligible to participate in this study?

This study is open to adults aged 18-60 years old that are diagnosed with schizophrenia and currently living with negative symptoms of schizophrenia. There are additional criteria for participation. To see if you or a loved one may be eligible for the study, please complete the short pre-screening questionnaire.

Where is this study taking place?

The INTERACT study is taking place at sites across the United States. Find the closest study site to you.

How long is this study?

The study is approximately 20 weeks long.

Screening: Approximately 4 weeks (1-2 study site visits)

  • You will visit the study center to see if the study is suitable for you and whether you want to take part. The study staff will perform some assessments to determine your eligibility.

Study Period: Approximately 14 weeks (10 study visits)

  • If found eligible, participants will be randomly chosen to receive either a placebo or a certain dosage of the investigational medication.
  • Participants will take their assigned study drug orally, once daily for approximately 14 weeks.
  • Participants will come into the study site once a week or every two weeks for tests to monitor their health and measure potential effects of their study drug.

Follow-up: 2 weeks (1 study site visit)

  • A single study site visit will be scheduled within 2 weeks of the participant’s last dose to follow-up with their condition after ending treatment.

What else should I know about participating in this trial?

Participants will be randomly chosen to receive either a placebo or a certain dosage of the investigational medication.

This study is double-blind, neither participants nor study site staff will be allowed to know whether a participant is taking the placebo or the investigational medication. This is to ensure the results of the study are as objective and reliable as possible.

In this study, it is important to know that all participants will receive placebo at some point during the study. All participants will continue to take their antipsychotic and other medications prescribed by their current physician throughout the entire study.

For many reasons, participants may not see an improvement in negative symptoms of schizophrenia while taking the study drug. This information is valuable to researchers too and for this reason it is important for you and your loved one to be straight-forward with the study staff about behaviors, thoughts, attitudes and beliefs experienced by the participant during the entire course of the study.

I have a loved one with schizophrenia who might qualify for this study. What should I do?

First, complete the pre-screening questions. If you or your loved one meets those criteria, you will be encouraged to reach out to the study site closest to you to arrange a screening visit at the study site.

If my loved one is in the study and no longer wants to participate, can they stop?

Participation in this study is completely voluntary, and participants are free to leave the study at any time. Study site staff will work with you and your loved one to prepare for stopping the study medication.

Will we have to pay for study-related medications or tests?

All study-related medications and tests will be provided to participants free of cost.

Will I have to miss work or disrupt my routine for the study?

Study site staff will work with you and your loved one to arrange study site visits that best accommodates your schedule.

Can my loved one continue to see their current physician while participating in the study?

Yes—we encourage all participants to continue seeing their current physician in addition to the care provided by study site staff.

Will my loved one’s health be monitored during the study?

Yes, all participants will receive close monitoring of their health and well-being throughout the study by the study doctor and other medically qualified site staff.

Will my transportation to/from the study site be reimbursed?

Yes, transportation costs incurred to and from the study site will be compensated. We want to make participating in the study as easy as possible for you and your loved one.

The INTERACT study is currently enrolling

This study is looking to partner with adults diagnosed with schizophrenia who are currently living with negative symptoms.


Find a study center near you

This study is taking place at a number of study sites across the United States.