What is the purpose of the study?
The purpose of the Enlighten Early study is to measure the effects of a new medication called ALK3831 on body weight in young adults with Schizophrenia, Schizophreniform or Bipolar Disorder. In this study, participants will be randomized to 12 weeks of treatment with olanzapine (also known as Zyprexa) alone, or with a new investigational agent called ALK3831, a combination of olanzapine and samidorphan, to help prevent weight gain.
Did you know?
Antipsychotic medications commonly used to treat Schizophrenia and Bipolar Disorder cause weight gain, which increases the risk for obesity-related illnesses like diabetes and heart disease. People with mental illness have shorter lifespans because of these conditions. Our study aims to find out: can combining antipsychotic treatment with a new medication help to prevent weight gain related to antipsychotic treatment?
To find out more about the study, and see if you are eligible, click “Register now” below.
What is involved in the study?
The treatment groups
You will be randomized to either olanzapine or to an investigational agent called ALK3831. Many participants ask what it means to be randomized and may assume that some groups receive a control, or placebo. In the Enlighten Early study, there is no control or placebo group. If you participate, you will receive treatment. Being randomized to one of the two treatments simply means you do not choose which treatment you will receive. Researchers place you in a treatment group randomly, like flipping a coin.
If the treatment is not effective, the investigative team will talk with you, your family and your physician to determine what treatment will best help you.
More information about the study medications can be found below.
If you are enrolled in this study, you and your family will be eligible to participate in a behavioral support program to help learn how to cope with having a mental illness and develop healthy lifestyle habits that can prevent symptom recurrence.
Research staff will contact you regularly to check in about your response to treatment, any continued symptoms, side effects, and medical compliance. Research staff will also stay in touch with your doctor to ensure you receive coordinated care.
You will be asked to complete 11 visits while you are in the study.
- Visit 1: The first visit is a screening visit where we will learn more about you, your symptoms and your treatment history.
- Visits 2-3: If you are enrolled into the study after your screening visit, you will be asked to come in for study visits once per week for the first two weeks.
- Visits 4-11: Your study visits will continue every other week for the next 14 weeks.
All study visits last 1-4 hours.
What medications are involved in the study?
Olanzapine is an atypical antipsychotic that has been approved by a number of different countries to treat schizophrenia and bipolar disorder. A common side effect of olanzapine is that it causes weight gain.
ALK3831 is a new, investigational study drug that contains the active ingredients of olanzapine and samidorphan that has been designed to reduce some of olanzapine’s weight gain.
Frequently Asked Questions
You will receive all study medications free of charge.
You will receive antipsychotic medication for free, and will receive state-of-the-art medical monitoring for treatment safety and effectiveness.
This study is 16-20 weeks long, and involves 11 in-person study visits.
You will receive $100 for each in-person study visit.
You are free to stop the study at any time, and stopping participation will not affect your health care in any way.
The Healthy Mind Lab is located in the Institute for Public Health Building which is also known as the Taylor Avenue Building.
600 S. Taylor Ave., Suite 121, St. Louis, MO 63110
- Free parking for study participants is available in the lot behind the building.
- Free visitor parking is available in two-hour increments in the lot in front of the building along Taylor Avenue.
- Hourly parking is available in the Clayton Avenue garage just south of our location at the corner of Clayton and Taylor Avenues. Parking meters are available along Scott Avenue.
The Central West End MetroLink station and the Central West End Transit Center bus stop is located one block west of our location.
Please let us know if you have circumstances that make traveling to our campus difficult for you and we will do our best to accommodate.
Click “register now” to find out if you might be eligible for the study, or you can call 314-362-3675 or email firstname.lastname@example.org to find out more about the study.