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Protocol Number:
89-M-0160
- Title:
Inpatient Evaluation of Neuropsychiatric Patients
- Number:
89-M-0160
- Summary:
The purpose of this study is to understand the biologic basis of schizophrenia and to determine which symptoms are related to the illness itself and which are related to medications used to treat the illness.
Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure. Brain imaging technologies such s positron emission tomography (PET), functional magnetic resonance imaging (fMRI), and magnetic resonance imaging (MRI) offer opportunities to study the pathophysiology of psychotic disorders by evaluating brain function. However, the use of anti-psychotic drugs may interfere with the results of such studies. In this study, psychotropic medication will be discontinued in patients for a short period of time to distinguish the effects of the illness on the brain without the interference of the medication's effects on the brain. Given that there is a risk that the patient's symptoms will increase, they are asked to stay on an inpatient unit where the NIMH clinical staff is available to help them 24 hours a day.
This study will be conducted in three phases. In Phase 1, participants will be admitted to the Clinical Center while continuing to take their medication and will undergo diagnostic interviews, physical and laboratory assessments, physiological monitoring, and neuropsychological testing. Behavioral ratings will also be performed and blood and urine samples will be collected. During Phase 2, participants will continue taking medications in a blinded fashion for 8 to 12 weeks. The active medications will be replaced with a placebo (an inactive pill) part of that time. PET, fMRI, and MRI scans will be used to monitor how the continuation or lack of medication affects the brain. Psychological tests will also be given to measure changes in cognition. In Phase 3, participants will have the opportunity for clinical stabilization.
- Sponsoring Institute:
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National Institute of Mental Health (NIMH)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
INCLUSION CRITERIA:
Inpatients admitted to the CBDB inpatient program at the Clinical Center must be age 18 or older, either male or female. There is no upper age limit. The primary recruiting emphasis is on patients with schizophrenia, schizoaffective disorder, and psychosis NOS. Subjects with other neuropsychiatric disorders may also be admitted and participate in the protocol if there is sufficient evidence to believe they have an underlying, undiagnosed schizophrenia, schizoaffective disorder, or psychosis NOS. Subjects identified as having major medical problems other than their primary neuropsychiatric disorder will be excluded from admission. Patients judged to be unsuitable for medication free studies will also be excluded. Possible reasons for exclusion include prior history of dangerousness to self or others, particularly when off medication.
Because of the long half life of depot medications, applicants to our program are not admitted if they have received a depot injection within 3 months, although exceptions may be made.
- Special Instructions:
To be considered for this study, the individual, their family, or their mental health professional needs only to call the referral number below for a confidential interview and/or an application. To be considered for the research, individuals need to apply. All applicants will be carefully considered for this research, but not all are accepted.
While there is no guarantee that the information gained during the research process will benefit volunteers directly, the expertise of the specialists and therapeutic resources are made available to the participants, all without cost to them. The clinicians of the schizophrenia research program endeavor to help increase the participant's understanding of their own illness. All efforts are made to have the participants leave the program stablized on medications observed to maximize their functioning.
An individual's right to refuse participation in any aspect of the research is respected at all times. Every effort is made to uphold the trust that the volunteers place in the excellence and safety of the NIMH research program.
Study procedures are discussed with volunteers who must show that they understand the written consent that they sign prior to participation. Participants come from all over the United Stated and the staff works very hard to help them stay in touch with their families through the use of a free telephone line and e-mail. With the participants' permission, the social worker on the unit will be in contact with family members and home clinicians so that they are kept in touch with the progress and needs of the participants.
- Keywords:
-
Schizophrenia
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Psychosis
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Neuroleptics
- Recruitment Keyword(s):
-
Schizophrenia
-
Schizoaffective Disorder
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Psychosis
- Condition(s):
-
Psychotic Disorder
-
Schizophrenia
-
Schizoaffective
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Paranoia
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Psychosis
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Institute of Mental Health
- Contact(s):
-
CBDB
National Institutes of Health Building 10 Room 1377 10 Center Drive Bethesda, Maryland 20892 Phone: (301) 435-8970 Fax: (301) 402-5503 Electronic Address: schizophrenia@intra.nimh.nih.gov
- Citation(s):
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Concurrent diagnostic validity of a structured psychiatric interview
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The semistructured BPRS interview and rating guide
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Intermittent medication for stable schizophrenic outpatients: an alternative to maintenance medication
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/17/2009
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