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Schizophrenia and Clinical Trials:
A Chance for New Hope
By Hilary Wright, Staff Writer

(Page 1 of 2)

Donna, a 55-year-old administrative assistant and mother of two, has been dealing with the effects of her son’s schizophrenia for the past five years. “It all began with my son’s paranoid behavior. Sean thought that everything around our home was out to get him, and that we were even trying to poison his food and drink. He started losing a lot of weight since he wouldn’t eat anything. When his behavior became even worse, I just figured that it was from a lack of nutrients. When he began experiencing hallucinations of strange people walking around our house at all hours, it became clear we needed to get him some sort of professional help. We’d actually been in denial, thinking that maybe he had become involved with drugs and that this period of experimentation would soon be over, but it just became too apparent that something else was the problem, because there was no “down time” from the paranoia or the hallucinations. Our family doctor had Sean admitted to a mental health facility for observation, and it was at this point that the diagnosis of schizophrenia was made. Our family then became one of several components which made up my son’s mental health team. After he was stabilized on medication, things were better but not perfect. This is when the doctors suggested that Sean be a part of a clinical trial for some new medication which showed a lot of promise in keeping the psychotic episodes in remission for a much longer time period.”

Many family caregivers of people living with schizophrenia, are unaware or afraid just the concept of a clinical trial.  Before it is possible to determine if there is a trial available that would help and how you might be able to get your loved one involved, you must first understand what a clinical trial is and what may be involved if someone decides to participate.  Simply defined, a clinical trial is a research study conducted by qualified physicians who are evaluating an investigational treatment for a specific disease or group of diseases. It’s important to know that prior to dispensing a medication to a study group of individuals, that it has been thoroughly researched in the laboratory for obvious or hazardous side effects. Clinical trials are a good way to study and test experimental treatments. All treatments in widespread use today were first proven effective and safe in clinical trials.

 Participation in a clinical trial is completely voluntary, and it may be a challenge to get a loved one with schizophrenia to actually trust enough to be able to do so. It’s best to approach your loved one when they have been stabilized for at least three months on their current medications. A person who decides to participate in a trial must be able to fully understand their decision and be able to meet all the study requirements. One of the benefits to joining a clinical trial is the opportunity to receive study-related physical exams, medical testing, and investigational medications at no cost and without being covered by medical insurance. Some studies even offer financial compensation for a person’s participation.

There are eligibility requirements and guidelines which must first be met in order for someone to be selected for participation such as: all written, consent forms must be dated and signed by the participant themselves before any study-related activities can begin.  Every trial is different but after the trial is over,  volunteers usually return to the clinic or doctor’s office after the last dose of medication, and then again a week later for a follow-up visit. They will not be asked to go off of the medication they are already taking while during the clinical trial, therefore they will be combining what they normally take with either the new medication or a placebo (containing no medication). 

One of the most essential parts of participating in a clinical trial is for the volunteer to follow the protocol exactly during the course of the trial.  This is especially difficult for a person living with schizophrenia as it is often a challenge to keep them on any medication for many reasons.  A caregiver can be especially important to the struggle to keep a loved one on the trial medication and exams over the time-line of the trial.

Caregivers can inquire about clinical trial research studies through their loved one’s physician or mental health expert, and they will be able to clarify what the medical requirements will be for the study. During a clinical trial, a person’s regular medical team will not be replaced, but instead, they will be included as part of the clinical trial team, helping to enhance all of the healthcare options available. With the participant’s consent, all study-related medical records will be shared with their physician, psychiatrist, and psychologist. A volunteer in a clinical trial always has the choice to withdraw from the study at any time, without compromising any present or future medical care. When the decision is made to volunteer for a clinical trial, you can expect to receive full disclosure regarding the benefits and the risks of participating in the study.

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