This study will test the effectiveness of an investigational medicine for schizophrenia or schizoaffective disorder in adults between the ages of 18 and 45 who have been diagnosed with either schizophrenia or schizoaffective disorder for less than 10 years. Qualified participants will also have a recent acute exacerbation of schizophrenia (or a psychotic exacerbation of schizoaffective disorder) with evidence of an intensification of psychiatric care of no more than 8 weeks and no signs of lack of treatment response.
To participate in this clinical research study, you must meet a set of qualifying criteria standards. Some are listed on this website, but a study representative will be able to explain additional details and potential exclusions.
Schizophrenia is a chronic psychotic disorder that affects almost 1% of the world’s population. Onset is typically late adolescence or early adulthood, and caused by many factors including genetic, environmental, or chemical. As the disorder progresses, symptoms may include delusions, hallucinations, disorganized speech, and disorganized behavior. Someone with schizophrenia might also suffer from a lack of normal behaviors such as emotional expression and interest/enthusiasm.
This study will last for 17 weeks, and qualified participants will be required to remain in inpatient care for a duration of this time. This study is also a randomized, double-blind, parallel, placebo-controlled trial. This means that some study participants will receive investigational medication, while other participants will receive placebo. The placebo will look exactly like the investigational medicine but will not have any active ingredients.
During the screening period, study staff will evaluate your mental and physical health to establish a baseline for your further participation in the study. You will need to remain in inpatient care for up to 7 days.
The study drug or placebo will be administered on Day 1 of the study. After receiving either the study drug or the placebo, you will need to remain in inpatient care for 4 weeks.
The study treatment period will last for 4 weeks and end on Day 28. After this period, you will no longer need to be in inpatient care, but you will be required to have 7 additional visits, including a final, end of study treatment visit and a follow-up visit with the study staff for further tests and evaluations.
Schizophrenia is chronic psychotic disorder that affects almost 1% of the world’s population. With a stable treatment regimen, schizophrenia is a very manageable condition. Potential treatments are not discovered without clinical research studies, which rely on potential subjects like you to test the safety and efficacy of treatments.
You or your loved one may qualify if you:
Additional study requirements and exclusions may apply. A study representative will discuss these with you during the screening period.
Through clinical research, scientists and doctors are able to determine whether a medical strategy, drug, or device is safe and effective for people. New treatments are not discovered without clinical research studies, which rely on potential subjects like you to evaluate their safety and efficacy. Participation in clinical research studies is voluntary. Potential subjects may cease participation at any time.
Investigational medication is tested in a laboratory setting. A clinical research study is used to test the safety and efficacy of an investigational medication. Investigational medications are not yet approved as safe or effective by the FDA; they are also not yet approved for sale by the FDA or any other government agencies or authorities.
Clinical research studies evaluate investigational medications through a series of screenings, clinical visits, medical or behavioral tests and assessments, and a drug dosing schedule. Study coordinators, nurses, and doctors work with you throughout the process to collect information about how you are feeling and reacting to the treatment.
Your rights, well-being, and safety are of the utmost importance to clinical researchers throughout the study. All clinical research studies must follow strict federal guidelines on how participants are treated. These guidelines must be reviewed and approved by an independent ethics review committee.
While it is important to remain in a clinical research study after enrollment, you have the right to cease your participation at any time for any reason. If you do decide to leave the study, speak with the study doctor first to discuss how leaving the clinical research study may affect your health, along with other treatment options.
You may receive compensation for your time and travel. A study representative will answer any questions regarding eligibility and documentation.
This study will be taking place in select study locations across the United States. If you are interested in participating but do not live near a study location, you may be eligible for reimbursement for travel expenses.