Study information: treatment-resistant schizophrenia
We appreciate your interest in learning more about this clinical trial.
Schizophrenia affects 2.4 million adults in the United States. Even though we’ve made tremendous strides in the treatment of this serious illness, approximately sixty percent of all patients continue to have significant symptoms of hallucinations, paranoia, poor social skills or cognitive impairment. Many of these patients struggle with unemployment, underemployment, completing their education, difficulties in maintaining independent living, as well as basic social and family relationships. This treatment trial addresses the individuals who have attempted treatment, but continue to have symptoms that impair their ability to function. You can learn more about schizophrenia here.
This clinical trial, called “DayBreak,” is sponsored by the international pharmaceutical company Lundbeck.
The study compares an investigational compound to two medications that are FDA approved to treat schizophrenia. The purpose of this trial is to determine if this compound more effectively relieves symptoms compared to the existing medications. All of the medications that are used to treat schizophrenia work on the dopamine receptors in the brain. This is a treatment study (there is no placebo group). Participants will receive either conventional or investigational therapy.
How is the study conducted?
Participants will come to Finger Lakes Clinical Research (at Twelve Corners in Brighton) every one or two weeks, for a period of up to 16 weeks. For the first six weeks, they will taper off their current medication and take one of the other currently approved schizophrenia medications. For the remaining weeks, one-third of the participants will continue to take the same medication, while the rest will switch to the study drug. Neither participants nor our study team will know who is taking which drug. During clinic visits, participants will have their health and condition monitored with medical/laboratory tests and questionnaires.
There is no cost to the participant and no insurance is required. Study participants are paid a stipend for each visit, for time and travel.
Dr. Sarah Atkinson is the principal investigator (PI) for this study. Dr. Atkinson is a board certified psychiatrist with over twenty years’ experience in the field of central nervous system disorders.
Please see the study information brochure for more detailed information on the study process.
Do you qualify for this study?
Every clinical study requires that participants meet certain criteria, and the information booklet gives some basic qualification guidelines for this study. Dr. Atkinson will need to see you to make a medical determination as to whether you (or the person you are caring for) are able to participate in the study, but you can get a quick idea of whether or not you (or he/she) may qualify by answering three quick questions: