An Evaluation Study of Schizophrenia
National Institute of Mental Health
The National Institute of Mental Health in
Bethesda, Maryland, invites qualifying adults
diagnosed with schizophrenia or schizoaffective
disorder to participate in an inpatient research
study at the NIH Clinical Center. In this six-month
study, researchers will be evaluating how the brain
works in individuals diagnosed with schizophrenia
to better understand the underlying causes of this
illness. No experimental medication is given to
participants and this study is not considered a
medication trial. At the Clinical Center participants
will have access to NIMH diagnostic expertise,
careful medication management, and a variety of
therapeutic and educational programs while
participating in research.
This 6 month study is divided into 3 phases:
The first phase involves an ongoing evaluation of
the participants’ diagnosis, medications, and
treatment. Evaluations include a variety of medical,
cognitive, neurological, and neurocognitive
assessments. Advanced neuroimaging techniques
(fMRI, MRSI, DTI, and PET scans) are used in
conjunction with specialized cognitive tests designed
to understand specific functions of the brain. During
this time, the research team also determines if it is
suitable for the volunteer to participate in the second
phase of research.
The second phase includes evaluations while on
and off medications. During this time, the volunteer
will not know when the pill he/she is taking contains
their psychiatric medication and when it does
not. The period when a volunteer is off of their
medications ranges from four to six weeks. There is
a risk that an individual’s psychiatric symptoms may
increase during this period. Twenty-four hour support
is provided by the monitoring clinical team during
this time. Volunteers can stop their study
participation and restart taking their usual medication
at any time and for any reason. Likewise, the NIMH
psychiatrists can restart medication at any time if a
volunteer's continued participation in the protocol
without medication is considered unsafe.
The third phase of the research participation
focuses on stabilization, treatment, and discharge
planning. Here, medications will be resumed and
participants may have the opportunity to try FDA-
approved/standard-of-care medications they have not
The National Institute of Mental Health, National Institutes of Health, Department of Health & Human Services
tried in the past. They will be stabilized on the
medication(s) determined to be the best therapeutic
option. At completion of the study, participants will
be discharged and return to the care of their own
mental health care providers. Discharge planning
includes written assessments and recommendations for
the mental health providers in the participant’s home
community.
It is important to understand the brain mechanisms
that may cause schizophrenia. The medication-free
approach helps researchers understand the biological,
behavioral, and cognitive aspects associated with
schizophrenia without the confounding effect of
psychotropic medications. Volunteers participate for
many different reasons. While there is no direct
medical benefit from being in this study, some
participate in the medication-free phase to receive a
clearer diagnostic picture of their illness and to
determine whether the medication they have been
taking is effective for the treatment of their condition.
Others, who intend to stop taking their medication,
come to participate in this research so that they can do
so in a safe environment where their condition is
closely monitored.
Adults who have been diagnosed with schizophrenia
or schizoaffective disorders may be eligible to
participate. While this study allows volunteers
interested in seeing how they can manage without
medications, the study is not suitable for everyone.
The severity of symptoms and the degree of expected
risk varies from one person to another. Thus,
candidates for this program are selected with great
care and only after the research team has a thorough
understanding of the candidates’ medical and
psychiatric history, current situation, and present
treatment. For details on how to apply for this
program, please contact:
NIMH SCHIZOPHRENIA
RESEARCH PROGRAM
301-435-8970 / 1-888-674-6464
(TTY: 1-866-411-1010)
Schizophrenia@mail.nih.gov
http://patientinfo.nimh.nih.gov
The inpatient care is provided
without charge to the participant.
Protocol #89-M-0160