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Inpatient Evaluation of Adults With Schizophrenia
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001247

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.

Psychotic Disorder

MedlinePlus related topics: MRI Scans Psychotic Disorders Schizophrenia
U.S. FDA Resources
Study Type: Observational
Official Title: Inpatient Evaluation of Neuropsychiatric Patients

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: September 1989
Detailed Description:

Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure. Neuroimaging technologies such as PET (positron emission tomography), fMRI (functional magnetic resonance imaging), DTI (diffusion tensor imaging) and MRSI (magnetic resonance spectroscopic imaging) offer opportunities to elucidate the pathophysiology by studying brain function in living patients. The use of these techniques to study psychotic disorders is severely limited, however, by a critical methodological confound: neuroleptic treatment. The purpose of this protocol is to admit patients with schizophrenia and other related disorders to the Clinical Center, carefully evaluate their neuropsychiatric status, and discontinue psychotropic medications for a brief period so patients can be studied without the confound of neuroleptic treatment. There are several phases to this protocol. The first phase is the evaluation phase and includes gathering historical data, structured diagnostic interviews, general physical and laboratory assessments, basic physiological monitoring, neuropsychological testing, limited collection of blood and urine samples, and serial behavioral ratings. In the second phase, patients will receive blinded compounds that will contain inactive placebo or active neuroleptic administered in a double blind, crossover fashion. Each arm normally lasts 4 to 6 weeks. The total duration of this phase is 8 to 12 weeks. During the coded neuroleptic period, patients are enrolled in a series of neuroimaging and other approved protocols designed to elucidate the neurobiology of these disorders. These include studies using PET, fMRI, DTI, and MRSI. The neuroleptic free period is essential to distinguish the effects of illness versus medication. Parameters under investigation include traits that are candidate phenotypes for genetic studies and state-dependent aspects of brain function. The combined use of many neuroimaging modalities will allow us to look at the functional relationship between a variety of brain abnormalities hypothesized to play a role in schizophrenia. These include hippocampal neurochemical abnormalities, deficits in prefrontal cortical activation, and dysregulation of subcortical dopamine in a single patient.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001247

Contact: CBDB (301) 435-8970 schizophrenia@intra.nimh.nih.gov

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Study ID Numbers: 890160, 89-M-0160
Study First Received: November 3, 1999
Last Updated: October 28, 2008
ClinicalTrials.gov Identifier: NCT00001247  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Schizoaffective Disorder

Study placed in the following topic categories:
Paranoid Disorders
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009