By Hilary Wright, Staff Writer
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
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.
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.
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.
important things that to remember when accepted into a clinical
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
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.
clinical trial will last as long as symptom do not worsen.
length of the clinical trial will also depend upon the side effects
that are experienced.
the clinical trial has been completed, he or she will be followed by
clinical trial doctor and staff for updates on their overall
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.
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.
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
scheduled visits, it’s important that your loved one:
any symptoms that have been experienced since starting the study or
changes in symptoms that were reported at previous visits.
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
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.