(Institution Name)
IRB #: (IRB Number)
Title of Study: A Comparison of Long-Acting Injectable Medications for Schizophrenia (ACLAIMS)
Principal Investigator: (Site PI)
Contacts: (Contact Information)
PURPOSE OF STUDY:
You are being asked to be in the study because you have a diagnosis of schizophrenia or schizoaffective
disorder and you might benefit from treatment with a long-acting injectable medication.
The purpose of this research study is to learn more about the different medications (called
antipsychotics) used to treat schizophrenia and schizoaffective disorder. Specifically, we are looking at
medications that are injected, instead of taken by mouth. Unlike pills, these medications do not need to
be taken every day. The medications we are looking at in this study are injected once every two weeks.
These medications are known as long-acting injectables. In this study, we are comparing the risks and
benefits of two long-acting injectables (risperidone microspheres and fluphenazine decanoate).
A total of approximately 360 people at 25 institutions will take part in this study, including
approximately 15 people from this institution.
Your participation in the study will last up to 42 months. We will be enrolling patients into the study
for approximately 18 months. If you enter the study near the end of this time, your participation will
last up to 24 months. When you enter the study, we will let you know how long it can last for you.
Two initial visits, the screening and baseline visits, will take approximately 1-3 hours. After the
screening and baseline visits, you will come to the clinic every two weeks to receive your medication.
Once a month we will meet with you to complete interviews and questionnaires. These monthly visits
may take from 1-3 hours. All of these visits are explained further in this document.
This study is funded by the U.S. National Institute of Mental Health. Risperidone microspheres have
been donated by Janssen Pharmaceutical, which makes and markets this drug.
ALTERNATIVES TO PARTICIPATION:
You do not have to take part in this study in order to receive treatment for your symptoms or to receive
the medications given in this study. Both risperidone microspheres and fluphenazine decanoate can be
prescribed by your own doctor. In this study you will not have a choice as to which medication you
receive. You should talk with your own doctor or the study doctor so you can understand if, based on
your history, one or the other medication might be better for you. There are also other treatments to
treat your symptoms. The research doctor will tell you about other treatments and other places where
you can get treatment if you decide not to participate in this research study. If you choose not to take
part, it will not affect you clinical treatment or limit your choices.
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STUDY PROCEDURES:
This study will take place at (Institution Name). While you are in the study, your clinical care will be
provided by the study psychiatrist.
While you are in this study, we will call you the day before your study visits to remind you of your
appointment. Before the visits where we draw your blood, we will also remind you not to eat or drink
anything before you come in for your visit.
Screening Visit: If you agree to participate in the study, you will first have a screening visit to
determine if you are eligible to participate. This visit will take about 2 hours to complete. We will ask
you to come to this visit in the morning, before you have had anything to eat or drink. At the screening
visit, we will ask you questions about your psychiatric and medical history; perform a physical exam;
measure your vital signs (blood pressure, heart rate, height, and weight); take a urine sample to test for
drug use; and take a blood sample for standard lab tests. We will also ask you to allow us to have
access to your medical records for the purpose of determining eligibility for the study now and if you
are admitted to a hospital or other facility later in the study.
Baseline Visit: The baseline visit will take place up to 21 days after the screening visit. During this
visit, we will ask you questions about your current symptoms of schizophrenia, side-effects you may be
having from your current medication, measure your vital signs and complete questionnaires. At this
visit and throughout the entire study, you can choose not to answer any question for any reason.
At this point, if you are eligible for our study and want to participate, you will be randomized to one of
the two study groups. Randomization means that you will be assigned to a group by chance alone (like
flipping a coin). You will be assigned either to the group that takes risperidone microspheres or
fluphenazine decanoate. You have an equal chance of being assigned to each group.
You will not know which group (risperidone microspheres or fluphenazine decanoate) you are assigned
to. Most of the research staff who you see during the study also will not know what medication you are
taking. The study nurse or doctor who injects your medication will know what medication you are
taking and can tell your doctors in the case of an emergency.
After you are assigned to an injectable study medicine you will first take an oral version of this
medicine for at least four days to make sure you do not have any initial problems with it. You will not
know which medication you are taking.
If you are able to take the oral version of the assigned medicine, after four days or more you will
receive your first injection of the long-acting medicine.
You will be provided with a small amount of benztropine. Benztropine is a medication that is used to
treat, tremors, restlessness, and muscle stiffness. If you develop tremors, restlessness, or muscle
stiffness you must contact your doctor immediately. Your doctor may instruct you to take the
benztropine you were provided. Your doctor will also schedule a visit to evaluate your symptoms.. .
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During the first two months of the study your current oral antipsychotic medication will be gradually
reduced while the injectable study medication starts to work and its dose is adjusted. By the end of
eight weeks your oral medication will be stopped completely, unless your symptoms are worsening.
Follow-up Visits: After your first injection, you will come to the clinic every two weeks for up to 42
months to receive an injection of your assigned study medication. As some of these visits, you will
meet with a clinician to complete additional study procedures. Those visits will take longer. Here is a
description of what the visits will be like:
For the First 3 Months:
For the first three months after the baseline visit, you will come to the clinic every two weeks, where
you will receive your medication injection, have your vital signs checked, and we will ask you about
any side effects you may be having. At every other of these visits (that is, once a month), you will also
be asked about your use of health care services and other questions. These visits will take about an
hour.
Months 4 - 24:
After the first 3 months, you will continue to come to the clinic every 2 weeks for your injections. At
every other of these visits (that is, once a month), we will collect your vital signs, ask about other
medications you are taking, and ask you to complete a questionnaire about your use of different kinds
of healthcare services. Once every 3 months during this time, your visit with be longer (lasting 2 to 3
hours). At that time we will also ask about the symptoms of your illness, your drug and alcohol use,
side effects, and your physical and social activities. And once every 6 months, we will also draw your
blood for standard lab tests.
Months 25 – 42:
During the last 18 months of the study, you will still continue to come to the clinic every 2 weeks for
your injections. However, the longer visits where we ask more questions will happen only every 6
months, and at the very end of the study.
If you end the study early for any reason, we would ask you to come in for a final visit at that time.
The final visit will include vital signs, other medications, questionnaire about your use of different
healthcare services, questions about the symptoms of your illness and side-effects you may be having
from your medications.
We will provide you with a schedule that will show exactly when you need to come to the clinic and
approximately how long your visit will take. We will try to call you the day before each visit to remind
you.
After the last study visit, your clinical care will be provided by your previous psychiatrist. If needed,
we can help you find a psychiatrist for ongoing care. Once the study has ended, the study physician
will not be involved in decisions about your treatment. Instead, these decisions will be made by you
and your ongoing psychiatrist.
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RISKS:
Whenever you change or start a new antipsychotic medication, there is a risk that the new medication
will not work well for you and that your symptoms will worsen. In this study we will gradually reduce
oral medications over the first 4-8 weeks that you receive injections. It is possible that your symptoms
will worsen as a result. We will ask you about your symptoms at every visit and provide treatment as
needed. If you need to change medications, you and your psychiatrist will decide what treatment is best
for you.
Side Effects of Study Antipsychotic Medications:
There are very rare, but potentially serious side effects associated with use of antipsychotic
medications. This class of drugs rarely can cause neuroleptic malignant syndrome (NMS). NMS is a
serious, potentially life-threatening, disorder that includes symptoms such as fever, tight muscles,
changes in blood pressure and heart rate, as well as confused thinking.
Over long periods of treatment, antipsychotics can rarely cause a movement disorder called tardive
dyskinesia (TD). TD consists of unusual movements of your face or body that you cannot control. This
side effect may not go away after treatment ends. You may have an increased risk of developing TD if
you are assigned to take fluphenazine decanoate and continue to take this medication for many months
or years. It is thought that fluphenazine decanoate is more likely than risperidone microspheres to
cause or worsen TD. We will monitor closely for movement disorders during this study and if you
have new or worsened abnormal movements then we will discuss with you and your psychiatrist all the
options available to you.
Antipsychotics have been associated with increased risk of heart disease by causing weight gain and
increases in blood sugar and cholesterol. It is thought that risperidone microspheres is more likely than
fluphenazine decanoate to cause weight gain or increases in blood sugar and cholesterol. We will
monitor your weight and blood tests during this study and if there are substantial changes that might
affect your health then we will discuss with you and your psychiatrist all the options available to you.
Antipsychotics have been reported to reduce the White Blood Cells (WBCs) that fight infection. This
decrease in WBCs is called leukopenia or neutropenia and can rarely lead to a very serious condition
called agranulocytosis that is potentially fatal. Agranulocytosis is a medical emergency that makes
people vulnerable to infections. If agranulocytosis develops then the study medication will be
discontinued and you will be referred for a medical evaluation and necessary treatment.
Previous work showed that some of the older antipsychotics are associated with an increased risk of
sudden cardiac death. Recent research has shown that all antipsychotics are associated with similar
risks for sudden cardiac death. The risk has been found to be approximately 3 deaths per 1000 patient
years. If a patient takes a medicine for one year, this is one patient-year. Three deaths in 1000 patientyears means that if a person takes an antipsychotic medication for one year, the risk of sudden cardiac
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death would be one out of 333. Because the risk increases with the dose of antipsychotic drug, we will
work with you to determine and use the lowest effective dose for your illness. However, there is some
risk at any dose. Your risk is the same whether you take these medications as part of the research study
or outside of this research study.
Side effects of the specific antipsychotic medications used in this study are listed below.
Common side effects occur in 1 – 20% of patients. Common side effects of risperidone microspheres
include: sleepiness, irregularity in menstrual cycle, weight gain, tremor, muscle stiffness, dry mouth,
vision problems, constipation, insomnia, headache, dizziness, lightheadedness, nausea, fatigue,
increases in chemicals made by the liver and increases in blood prolactin level. Having too much
prolactin in the blood can cause a decreased interest in sex, decrease in sexual function, or breast
enlargement.
Rare side effects occur in less than 1% of patients. Rare side effects of risperidone microspheres
include a rash that appears after spending a very short time in the sun (not a sunburn), a decrease in
sexual functioning, decreases in white blood cell counts, retention of urine, and breast enlargement.
Very rare side effects occur in less than 0.1% of patients. A very rare side effect of risperidone
microsphere is difficulty in regulating your body temperature.
Common side effects of fluphenazine decanoate include: local tissue reactions at the site of injection,
constipation, blurred vision , dry mouth, a drop in blood pressure that occurs when going from lying
down to sitting or standing, which results in dizziness and lightheadedness, drowsiness, difficulty in
passing urine, tremors, muscle stiffness, and increases in blood prolactin level. Having too much
prolactin in the blood can cause a decreased interest in sex, decrease in sexual function, or breast
enlargement.
Other Study Medication Side Effects:
During the study, you may be prescribed benztropine to lessen the side-effects from your antipsychotic
medication. The common side effects of benztropine are listed below.
Common side effects of benztropine treatment may include: Fast heartbeat, constipation, vomiting,
nausea, dry mouth, confusion, disorientation, difficulty with memory, visual hallucinations, worsening
of pre-existing psychotic symptoms, nervousness, depression, lack of energy, numbness of fingers,
blurred vision, dilated pupils, difficulty urinating, painful urination, heat stroke, or fever.
Other risks and discomforts:
We will take blood samples at some visits. There may be temporary discomfort when blood samples are
taken and there is a small risk of bruising, infection or inflammation at the needle stick site. Some
people may feel faint or dizzy after giving only a small amount of blood. We will use routine blood
draw procedures (e.g. sterile technique) to minimize the risk of the blood draw.
We do not know the effect of the study drugs on babies before they are born, or on nursing babies. If
you are a woman and you are planning to get pregnant, you should not be in the study. Many drugs can
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get into the mother's milk. You should not breast feed your child while taking the study drug. If you
are a woman who can become pregnant, you will have a pregnancy test at the start of the study. These
tests will be paid for as part of the study. If you are a woman who can become pregnant, you must use
an adequate method of birth control throughout the study and for up to 4 weeks after you finish the
study. Acceptable methods of birth control include oral, injectable or implanted contraceptives,
intrauterine devices, or barrier methods such as condoms, diaphragm and spermicides. If you become
pregnant during the study you should notify the researcher right away.
In addition, there may be uncommon or previously unknown risks that might occur. You should report
any problems to the researchers.
BENEFITS:
Research is designed to benefit society by gaining new knowledge. Since you will be receiving one of
two FDA-approved treatments for schizophrenia, you may benefit from this treatment. Receiving a
shot could increase the regularity with which you take your medications and this may lead to an
improvement in your symptoms. You may also benefit from having a better understanding of your
physical health. Society may benefit from a better understanding of the risks and benefits of these
study medications.
COSTS AND COMPENSATION:
There is no cost to you for participation in this study. You will be receiving payment for taking part in
this study. You will receive $25 for attending each longer visit to help pay for travel expenses and your
time. In addition, you will receive $10 for travel expenses when you come in for the shorter
medication-only visits. The total will be $1,635 if you complete all visits. If you withdraw or are
withdrawn by the study clinicians before you finish the study, you will be paid only for the study visits
that you have attended.
CONFIDENTIALITY:
Every effort will be taken to protect your identity in this study. We will assign a number to you and
omit your name from all documents on which information is recorded as part of the study. We will
keep personal identifying information needed to contact you to arrange study appointments separate
from all information collected as part of this study, in a password protected computer file. Study
records will be kept in a locked office. No subjects will be identified in any report or publication about
this study. Identifiable data will be available only to project staff at (Site Name) study monitors and
other representatives working for Columbia University and to (Site’s IRB).
Although every effort will be made to keep research records private, there may be times when we
would otherwise be required to disclose such records, including personal information. This is very
unlikely, but if such disclosure is ever demanded,(Site Name) will take steps which include the use of
the Certificate of Confidentiality, to resist disclosing personally identifiable information. However, we
will report information to prevent things such as child abuse or neglect, elder abuse, or to prevent
serious harm to you or someone else. In some cases, your information in this research study could be
reviewed by representatives of the University, research sponsors, or government agencies for purposes
such as quality control or safety.
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A copy of this consent form will go into your medical record. This will allow the doctors caring for
you to know what study medications or tests you may be receiving as a part of the study and know how
to take care of you if you have other health problems or needs during the study. However, it should be
noted that medical records may be reviewed by an insurer or other benefit payer.
To help us protect your privacy, we have applied for a Certificate of Confidentiality from the National
Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that
may identify you, even by a court subpoena, in any federal, state, or local civil, criminal,
administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any
demands for information that would identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the United States
Government that is used for auditing or evaluation of federally funded projects or for information that
must be disclosed in order to meet the requirements of the federal Food and Drug Administration
(FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member of your
family from voluntarily releasing information about yourself or your involvement in this research. If an
insurer, employer, or other person obtains your written consent to receive research information, then the
researchers may not use the Certificate to withhold that information.
RESEARCH STANDARDS AND RIGHTS OF PARTICIPANTS:
Participation in this research study is voluntary. If you decide not to participate, or if you later decide
to stop participating, you will not lose any benefits to which you are otherwise entitled. A decision not
to participate will not affect your treatment at (Site Name). Federal regulations require that we inform
you about our institution's policy with regard to compensation and payment for treatment of researchrelated injuries. Short term emergency medical treatment, which has been determined to be necessary
by (Site Name) doctors, and which is within the capability of (Site Name) will be provided. In
addition, we will provide assistance in arranging follow up care in such instances.
(Site Name) does not provide compensation or payment for treatment of research related injuries.
However, you should be aware that participation in this research does not waive any of your legal rights
to seek such compensation through the courts.
We will answer to the best of our ability any questions you may have about this research study. If you
have any other questions, now or in the future, about the procedures or about your response to the
procedures, you can call the Principal Investigator,(PI Name) at (telephone number). ( Site’s IRB)
has approved recruitment for this study. If you have any questions about your rights as a research
subject or any complaints, you may call the(Site’s IRB) Administrative Director a (telephone
number)during regular office hours.
You will be notified of significant new findings that may relate to your willingness to continue in the
study.
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You will be given a copy of this Consent Form to keep.
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Documentation of Consent
I voluntarily agree to participate in the research study described above.
Print Name______________________________________________
Date________________Signature____________________________________________
I have discussed the proposed research with this patient, and, in my opinion, this patient understands
the benefits, risks and alternatives (including non-participation) and is capable of freely consenting to
participate in this research.
Print Name_____________________________________________
Date________________Signature____________________________________________
Study Investigator
I have examined ____________________________ on ___________________ for the purpose of
determining whether he or she is capable of understanding the purpose, nature, risks, benefits, and
alternatives (including non-participation) of the research, making a decision about participation, and
understanding that the decision about participation in the research will involve no penalty or loss of
benefits to which the patient is otherwise entitled, for the research project “A Comparison of LongActing Injectable Medications for Schizophrenia”. On the basis of the examination I conclude that:
_____ A. This patient has this capacity at this time.
_____ B. There is a question about this patient's capacity at this time.
_____ C. This patient clearly lacks this capacity.
Printed Name___________________________________________
Date____________ Signature_______________________________________________
Member of Treatment Team (M.D. only), not Co-Investigator
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