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. A person will be accepted into the clinical trial once they have received a study-related medical evaluation and a diagnosis is made. After passing the evaluation and diagnosis procedures, it will be time for you and your loved one to ask important questions regarding all aspects of the clinical trial. Once enrolled, the trial will begin with a study-related physical exam, study medication, laboratory tests, and any necessary procedures that are required. During the course of the clinical trial, medical professionals will meet with your loved one on a regular basis in order to monitor their progress and to look for signs of either improvement or problems.

Some very important things that to remember when accepted into a clinical trial:

• It is very important to take all medicine as directed by the medical staff
  during the clinical trial; even if the participant doesn't feel as though the     medicine is working, encourage them to stick to the program.

• Make sure that he or she is aware of all the benefits as well as the possible risks associated with the clinical trial, and that they are able to comprehend this  information. 

• The clinical trial will last as long as symptom do not worsen.

• The length of the clinical trial will also depend upon the side effects that are experienced.

• Once the clinical trial has been completed, he or she will be followed by
  the clinical trial doctor and staff for updates on their overall well-being.

• A supply of the study drug will be given either at their doctor's office or it can be  filled at the local pharmacy. 

• If any mental or physical side effects are experienced, call their doctor; these professionals can be called at any time, and it  is extremely important that they are told of any possible problems, even if you don’t think it's related to the study medication.  

• Your loved one may be asked to bring their bottles of medication belonging to the study to each of their visits with the clinical trial team.

• When participating in a clinical trial, a "visit" schedule must be followed       where the clinical trial team monitors the participants well-being, in order to evaluate whether the treatment seems to be working.

• There will be a schedule to follow regarding when they are to have  important blood tests done; these can be weekly, or every few weeks, and will  be monitored by both their regular doctor and by the clinical trial doctor.

At these scheduled visits, it’s important that your loved one:

• report any symptoms that have been experienced since starting the study or any changes in symptoms that were reported at previous visits.

• report any other medications taken since starting the study or any changes in medication that were reported at previous visits.

• complete as much information needed on any questionnaires about health and overall well-being.

• expect that blood will be drawn for routine laboratory tests.

As always, it’s extremely important that the trial volunteer take the medication from the clinical trial as directed. They also need to report any side effects experienced at any time, so that the clinical trial doctor will know as soon as possible in order to give appropriate medical attention if necessary. If they are able to successfully stick to the routine of a clinical trial, you may be nicely surprised to find your loved one is receiving the most promising care available to date, and that the schizophrenia will begin to have less and less control over everyone’s lives. 

 

 Subscribe to our weekly e-newsletter