Completed

Frontal Lobe Function and Cognitive Stimulation Analysis Using Oxygen-15 Water PET in Normal and Neuropsychiatric Disorder Patients

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Study Aim

This study aims to observe how your brain functions during specific tasks by using Oxygen-15 Water PET scans, comparing individuals with neuropsychiatric disorders to those without.

What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Synucleinopathies+13

+ Basal Ganglia Diseases

+ Mental Disorders

From 18 to 90 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 1993
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: August 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 26, 1993

Actual date on which the first participant was enrolled.

The purpose of this work is to investigate the role of the frontal lobe and its connections for cognition in health and in neuropsychiatric diseases, particularly schizophrenia. Regional cerebral blood flow (rCBF) will be measured with oxygen-15 water positron emission tomography (PET) while subjects are either at rest or are performing a variety of neuropsychological tests. Some of these tests involve cognitive operations that are posited to depend upon the frontal cortex, such as the use of working memory for abstract reasoning and problem solving, formation and maintenance of conceptual sets, set shifting, sequencing, and delayed response; others control for nonspecific sensory and motor aspects of these measurements or are contrast conditions posited to depend on other brain regions. Interactions between regional activation, cognitive behavior, and neuropharmacology will be assessed by measuring cognitively-related rCBF during treatment with drugs that may affect frontal lobe physiology. Hypotheses about the genetic determinants of these relationships will also be tested by comparing rCBF measures across individuals harboring different genotypes (determined through protocol 95-M-0150).

NCT00001258
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: August 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1039 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersMovement DisordersNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersSchizophrenia Spectrum and Other Psychotic DisordersParkinsonian DisordersParkinson DiseasePsychotic DisordersSchizophreniaCognitive Dysfunction

Criteria

* INCLUSION/EXCLUSION CRITERIA: Participants in this study will reflect the diversity of the community. No one will be excluded or discriminated against on the grounds of race, gender, religion or ethnic background. Every attempt will be made to include women and minorities in the study population. Children will not be studied because of radiation exposure limits on this group. Normal control subjects will be recruited through the NIH normal volunteer program, through advertisement in the community and primarily through the "Genetic Study" under protocol 95-M-0150. An additional control group of non-schizophrenic siblings of patients with schizophrenia will also be recruited (from the community and protocol 95-M-0150, A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings). Control subjects will be matched to the patient groups by age, sex, and handedness. Control subjects with a history of psychiatric or neurologic disorders or medical illnesses or surgeries that might have relevance to the investigation of brain physiology will be excluded. Control subjects requiring continuous treatment with prescribed medications that impact cerebral blood flow and metabolism will be excluded. Control subjects unable to refrain from nicotine or caffeine for at least 4 hours or alcohol for at least 12 hours prior to the PET study will be excluded. Control subjects with exposure to other substances with relevance to cerebral blood flow and metabolism, such as some over-the-counter medications, will be reviewed in each individual case, to ensure that an adequate period of abstinence will precede the performance of the PET study. Patients with schizophrenia spectrum disorder will be recruited from the inpatient population of the NIMH Wards at the NIH Clinical Center and from the sibling study protocol 95-M-0150. Diagnoses will be made by the NIMH clinical staff in accordance with DSM-IV(R). Patients with history of neurological illness other than those of interest to the study, or other medical illness or surgery that might have impact on the study of brain physiology, will be excluded. Inpatients on the NIMH Schizophrenia Ward will have signed protocol 89-M-0160 ("Inpatient Evaluation of Neuropsychiatric Patients") and will be studied after being free of neuroleptic treatment for at least two weeks. They may also be studied when they are stabilized on medication; however, no treatment decisions, for inpatients or outpatients, will be based upon this study. All inpatients will be carefully monitored on the NIMH/NIH wards as per protocol 89-M-0160. Additional neuropsychiatric patients (such as those with affective disorder, Parkinson's Disease, special genetic disorders (e.g. William's Syndrome), and other neuropsychiatric disorders) will be recruited from the medical community, from NIH inpatient and outpatient services, and through the National Alliance for the Mentally Ill (NAMI). Patients will be identified by the presence of typical symptoms and signs elicited by history and examination. Diagnoses will conform to accepted diagnostic guidelines where applicable. Such patients will be excluded from study for 1) history of psychiatric or neurologic disorders other than those under investigation, 2) medical illnesses or surgeries that might have relevance to the investigation of brain physiology, 3) current medications that are not under investigation and that have relevance to cerebral blood flow and metabolism, and 4) IQ less than 70. Patients unable to refrain from nicotine or caffeine for at least 4 hours or alcohol for at least 12 hours prior to the PET study will be excluded. Patients with exposure to other substances with relevance to cerebral blood flow and metabolism, such as some over-the-counter medications, will be reviewed in each individual case, to ensure that an adequate period of abstinence will precede the performance of the PET study. Outpatients may be admitted overnight if necessary or otherwise applicable (e.g. those from out of town). No cognitively impaired nonschizophrenic subjects are studied in this protocol. For Parkinson's Disease patients, information is obtained from referring physicians, from NIH medical records for participants already enrolled in the NIH system, and by phone from the potential participant. Further assessment is carried out by a neurologist or psychiatrist upon arrival at the NIH. For Williams syndrome patients, IQ testing is done off-site by a certified clinical neurophysiologist who refers patients for our study and who has followed large numbers of these rare individuals for years.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
CompletedOne Study Center