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Protocol Details

Inpatient Evaluation of Neuropsychiatric Patients

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women



Recruitment Keyword(s)

Schizoaffective Disorder;



Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Mental Health

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.

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-Diagnosis of DSM-IV- or DSM5-defined schizophrenia spectrum disorder (including schizophrenia, schizoaffective disorder, or other specified/unspecified schizophrenia spectrum and other psychotic disorder/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 DSM-IV-or DSM5-defined schizophrenia spectrum disorder.


-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 currently 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. A sufficient washout period based on the particular long-acting injectable medication s elimination half-life will be required in order for prospective participants to be eligible. Subjects may 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.

-Infection with syphilis, hepatitis, or HIV.

-History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).

-Cumulative lifetime history of any (excepting nicotine-related and cannabis-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.

-Lack of capacity to provide consent.

Exclusion Criteria for Previously Enrolled Research Subjects

-No longer satisfying the above inclusion criteria or meeting any of the above exclusion criteria

-Inability to safely participate in planned research (e.g., development of acute suicidal behavior during prior research participation)

-Unlikely to provide sufficient additional research data

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Egan MF, Goldberg TE, Kolachana BS, Callicott JH, Mazzanti CM, Straub RE, Goldman D, Weinberger DR. Effect of COMT Val108/158 Met genotype on frontal lobe function and risk for schizophrenia. Proc Natl Acad Sci U S A. 2001 Jun 5;98(12):6917-22. Epub 2001 May 29.

Meyer-Lindenberg A, Miletich RS, Kohn PD, Esposito G, Carson RE, Quarantelli M, Weinberger DR, Berman KF. Reduced prefrontal activity predicts exaggerated striatal dopaminergic function in schizophrenia. Nat Neurosci. 2002 Mar;5(3):267-71.

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Principal Investigator

Referral Contact

For more information:

Daniel P. Eisenberg, M.D.
National Institute of Mental Health (NIMH)
(301) 402-5483

Vincent L. Del Balzo
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 10
Room 7SE-5340
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8974

National Institutes of Health
Building 10
MSC 1377
Bethesda, Maryland 20892
(888) 674-6464

Clinical Trials Number:


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