Clinical Connection

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

With Negative Symptoms of Schizophrenia, people lose their desire to do anything.

If you know someone who has schizophrenia and is displaying negative symptoms, including a lack of drive and motivation and limited interaction with others, learn about this research study evaluating an investigational drug for NSS. Trial ID: 18-AVP-786-207

Trial ID: NCT03896945 MLR-786-US-0664-0221

Research studies are different than regular medical care because the purpose of research studies is to gather information about an investigational drug. Pharmaceutical companies use research studies to evaluate an investigational drug’s safety and effectiveness. Using the information collected in research studies, doctors and regulatory agencies can determine if an investigational drug for a specific condition could one day be made available to the public. In order to conduct research studies, doctors need volunteers to participate in these studies. By participating in this study, you or someone you care about could help advance research related to negative symptoms of schizophrenia.

Trial Details

About Negative Symptoms of Schizophrenia

Managing Schizophrenia symptoms can be a daily challenge for you or someone you love. Medication for schizophrenia symptoms, which are usually classified as positive or negative, is only effective in treating positive symptoms, such as hallucinations or delusions.

However, nearly 60% of people with stable schizophrenia experience at least one negative symptom. These symptoms can include reduced facial expressions and speech, a lack of motivation and enthusiasm, and limited interaction with other people.

Although many people with schizophrenia experience negative symptoms, the United States Food and Drug Administration (FDA) has not approved any medications for the treatment of these symptoms.

As a result, doctors in this study want to learn about an oral investigational drug for treating negative symptoms of schizophrenia. The results of this study will provide more information about whether the investigational drug could one day help people who have schizophrenia and experience negative symptoms.

Estimated Enrollment

370 Participants

Phase

Eligibility Criteria

Participants must:

To pre-qualify for this study, participants must:

• Be 18 to 60 years of age

• Have had onset of symptoms of schizophrenia for at least 1 year and been clinically stable for at least 6 months

• Be taking antipsychotic medication

• Have experienced negative symptoms for at least 6 months

• Have a reliable study partner who can answer questions about them

Additional criteria will be reviewed by the study doctor.

All study-related visits, tests, and drugs will be provided at no cost. In addition, compensation for completed study visits may be provided.

Participants must not:

Additional criteria will be assessed by the study doctor

Commitments from you

What’s Involved

Participants will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. All participants have an equal chance of being assigned to receive either study drug (investigational or placebo).

Participants, study partners, the study doctor, and the study staff will not know the study drug assignments. However, in the event of an emergency, this information can be provided to the study doctor.

Participants will take their assigned study drug two times a day for approximately 15 weeks. Total study participation will last approximately 23 weeks.

Study participation includes seven visits to the study center and six phone calls from the study staff. At study center visits, the study doctor and study staff will evaluate participants’ health and response to their study drug.

Every participant in this study will need a study partner who can answer questions about them. The study partner can be a family member, close friend, group home manager, or case worker.

Additionally, participants may be allowed to continue taking their current schizophrenia medication. The study doctor will talk with participants about which medications they are allowed to take in this study.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

Yes, you will be reimbursed for your time. We realize it takes a lot of time to come for study visits, so we want to make sure this is not too much of a burden for you. The study site will review all these details with you. Also, you do not have to pay anything to be in the study. All study related services are provided at no cost.

What is a placebo?

In order to understand if the investigational drug works, medical researchers are comparing the investigational drug to a placebo. A placebo looks like the investigational drug being tested but does not contain the drug.

All study volunteers will receive the same level of quality care regardless of if they are assigned to the investigational drug or the placebo.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new vaccines or treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, sex, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples.

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.

Notices and other information

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