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:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

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 their is sufficient evidence to believethey 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

Psychosis

Neuroleptics

Recruitment Keywords:

Schizophrenia

Schizoaffective Disorder

Psychosis

Conditions:

Psychotic Disorder

Schizophrenia

Schizoaffective

Paranoia

Psychosis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

CBDB
Clinical Brain Disorders Branch
NIMH Schizophrenia Research
National Institutes of Health
Building 10
Room MSC 1377
10 Center Drive
Bethesda, Maryland 20892-137
Phone: 1-888-674-6464 or
Phone: (301) 435-8970
Fax: (301) 402-5503

Electronic Address: schizophrenia@intra.nimh.nih.gov

Citations:

Concurrent diagnostic validity of a structured psychiatric interview

The semistructured BPRS interview and rating guide

Intermittent medication for stable schizophrenic outpatients: an alternative to maintenance medication

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004