NCT00001320

Brief Summary

Brain cells communicate with each other by releasing chemicals called neurotransmitters. In order for brain cells to transfer information, one cell will release a neurotransmitter that will be recognized by a receptor located on surface of another cell. One such neurotransmitter is dopamine. Abnormal dopamine transmission has been seen in patients with substance abuse and different neuropsychiatric disorders including schizophrenia. A radioactive drug called IZBM (I-123 iodobenzamide) can also bind to certain dopamine receptors. IZBM can be seen by Single Photon Emission Tomography (SPECT). Therefore, by using IZBM and SPECT scans, researchers can find and "map" the location of dopamine receptors in the brain. Patients participating in this study must also have been selected for other genetic studies being conducted at the NIMH. Patients with schizophrenia will be selected from a NIMH research study titled, "Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings" (95-M-0150). Normal patient volunteers will be selected from another NIMH study titled, "Inpatient Evaluation of Neuropsychiatric Patients" (89-M-0160). All aspects of clinical care and genetic analysis of these patients will be covered in these studies, while information pertaining to IBZM SPECT scans will be covered in this study. This study will not directly benefit patients participating in it. However, information gathered may contribute to faster and more accurate diagnosis of schizophrenia and eventually better treatment for the disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1991

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1991

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

July 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Parkinson's DiseaseSchizophreniaDopamine D2/D3 receptorsBrain ImagingSPECTEquilibriumBrain ScanBrain ResearchBrain DisordersSchizoaffective DisorderNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with schizophrenia will be recruited exclusively from among inpatients who are participating in clinical studies of the Clinical Brain Disorders Branch of NIMH under NIH protocol #89-M-0160 (Egan 1999a) and for whom genetic data is already available.
  • Normal volunteers will be recruited exclusively from among individuals who have volunteered for studies under NIH protocol #95-M-0150 (Egan 1999b) as normal control subjects and for whom genetic data is already being analyzed.

You may not qualify if:

  • Pregnancy: All women of childbearing age must undergo a pregnancy test prior to injection or radioactive isotope. If the pregnancy test is positive or if the woman has reason to believe she might be pregnant, she will be excluded from this study.
  • Breastfeeding: Women who are breastfeeding will be excluded from this study to avoid unwarranted risk to their children.
  • Iodine sensitivity: Subjects with a prior reaction to iodine, iodine compounds, or shellfish will be excluded from this study. Also, subjects with a history of thyroid disease or dysfunction will be excluded from this study.
  • Substance abuse: Subjects with a history of recent substance abuse will be excluded from this study.
  • Metal objects in body: Subjects with metal objects in their bodies as specified in our MRI protocol (91-M-0124) will be excluded from this study.
  • Prior participation as a NIMH inpatient under NIH protocol #89-M-0160.
  • Schizophrenia diagnosis according to DSM-IV criteria.
  • Coexistence of another mental illness at the time of the study. If the patient has experienced other mental illnesses in the past (e.g. a learning disability or major depression), then this should be judged to be fully recovered.
  • Prior participation as a normal volunteer under NIH protocol #95-M-0150.
  • No Axis I or Axis II diagnoses.
  • Subjects with an Axis I or II disorder will be excluded.
  • Subjects with concomitant medical or neurological disorders which require ongoing medication, or which may affect the central nervous system will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Knable MB, Egan MF, Heinz A, Gorey J, Lee KS, Coppola R, Weinberger DR. Altered dopaminergic function and negative symptoms in drug-free patients with schizophrenia. [123I]-iodobenzamide SPECT study. Br J Psychiatry. 1997 Dec;171:574-7. doi: 10.1192/bjp.171.6.574.

    PMID: 9519100BACKGROUND
  • Knable MB, Heinz A, Raedler T, Weinberger DR. Extrapyramidal side effects with risperidone and haloperidol at comparable D2 receptor occupancy levels. Psychiatry Res. 1997 Sep 29;75(2):91-101. doi: 10.1016/s0925-4927(97)00023-1.

    PMID: 9351491BACKGROUND
  • Wolf SS, Jones DW, Knable MB, Gorey JG, Lee KS, Hyde TM, Coppola R, Weinberger DR. Tourette syndrome: prediction of phenotypic variation in monozygotic twins by caudate nucleus D2 receptor binding. Science. 1996 Aug 30;273(5279):1225-7. doi: 10.1126/science.273.5279.1225.

    PMID: 8703056BACKGROUND

MeSH Terms

Conditions

SchizophreniaParkinson DiseaseBrain DiseasesPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

October 1, 1991

Study Completion

July 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-07

Locations