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Inpatient Evaluation of Adults With Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00001247
First received: November 3, 1999
Last updated: August 31, 2016
Last verified: July 2016

November 3, 1999
August 31, 2016
September 1989
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Complete list of historical versions of study NCT00001247 on ClinicalTrials.gov Archive Site
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Inpatient Evaluation of Adults With Schizophrenia
Inpatient Evaluation of Neuropsychiatric Patients

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.

Objectives:

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 research subjects. The use of these techniques to study psychotic disorders is severely limited, however, by a critical methodological confound: antipsychotic treatment. The purpose of this protocol is to admit research subjects with schizophrenia and other related disorders to the Clinical Center, carefully evaluate their neuropsychiatric status, and discontinue psychotropic medications for a brief period so research subjects can be studied without the confound of antipsychotic treatment.

Study Population:

600 participants; The study will include research subjects with schizophrenia.

Study Design:

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, research subjects will receive blinded compounds that will contain inactive placebo or active antipsychotic 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 antipsychotic period, research subjects are enrolled in a series of neuroimaging and other approved studies designed to elucidate the neurobiology of these disorders. These include studies using neuropsychological testing, MEG, PET, fMRI, DTI, and MRSI. The antipsychotic free period is essential to distinguish the effects of illness versus medication.

Outcome Measures:

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 research subject.

Observational
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  • Psychotic Disorder
  • Schizophrenia
  • Schizoaffective
  • Paranoia
  • Psychosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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  • INCLUSION CRITERIA:
  • Age 18 or older
  • Male or female
  • Diagnosis of Schizophrenia, Schizoaffective Disorder or 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.

EXCLUSION CRITERIA:

  • Currently treated with depot medications: Because of the long half-life of depot medications such as paliperidone palmitate (Invega Sustenna), applicants to our program will be excluded if they are receiving depot medications monthly. However, applicants may decide to switch from depot to oral medications on their own, in conjunction with their personal physician, before coming to the program. This is not part of research and we do not participate in this decision. Most depot medications require a 6 months washout period. To meet this requirement, however, if medications are changed to the oral compound 3 months prior to admission, or if they are receiving risperidone powder (Risperdal Consta) which only requires a 3 month washout, subjects could be admitted. In these cases they could complete the last 3 months of washout in the inpatient unit while being evaluated under the standard protocol.
  • Major medical illness: Research subjects identified as having major medical problems other than their primary neuropsychiatric disorder will be excluded from admission.
  • Applicants 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.
  • Applicants who are pregnant are excluded from this study. Volunteers who are found to be pregnant after testing will be terminated from study and referred to an OB-GYN for follow up care.
  • Applicants 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.
  • Infection with syphilis, hepatitis, or HIV.
  • History of substance or alcohol abuse for over 5 years lifetime total is exclusionary. Subjects with recent substance abuse (no more than 3 months prior to admission) could be considered for admission on a case by case basis as long as the 5 year lifetime abuse criterion is not present.
Both
18 Years and older   (Adult, Senior)
No
Contact: Joann Berkson, R.N. (301) 451-0167
Contact: Daniel P Eisenberg, M.D. (301) 402-5483 eisenbergd@mail.nih.gov
United States
 
NCT00001247
890160, 89-M-0160
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National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
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Principal Investigator: Daniel P Eisenberg, M.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP