HealthyNCT00001320
Neuroimaging of Dopamine Metabolism in Normal and Psychiatric Patients
An observational study of Healthy and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Schizophrenia
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1991to Jul 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- Prior participation as a NIMH inpatient under NIH protocol #89-M-0160.
- Schizophrenia diagnosis according to DSM-IV criteria.
- Prior participation as a normal volunteer under NIH protocol #95-M-0150.
- No Axis I or Axis II diagnoses.
Who cannot join
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: I-123 Iodobenzamide (IBZM) SPECT Studies of D2 Receptor Distribution and Function in Patients With Schizophrenia and Normal Volunteers
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.
Read more
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.
Read the detailed description
Abnormalities in dopaminergic neurotransmission have been described in substance abuse and different neuropsychiatric disorders including schizophrenia. [I-123] IBZM is a radioligand that has been widely employed for SPECT imaging of dopamine type 2 and type 3 receptors (D2 and D3, respectively) and fluctuations in levels of endogenous dopamine. [I-123] IBZM SPECT has been used in the SPECT Lab of the Clinical Brain Disorders Branch for several years without adverse effects. Pharmacological effects of IBZM are unlikely due to the minimal amounts used and have not been observed. We propose to use [I-123] IBZM SPECT to explore following questions: 1) Can a previously found relationship between N-acetylaspartate (NAA) measures in the dorsolateral prefrontal cortex and striatal dopamine activity in patients with schizophrenia be replicated and is it also found in normal subjects? 2) Do allelic variants of genes for the dopamine type 2 (DRD2) and type 3 (DRD3) receptors, the dopamine transporter (SLC6A3), or enzymes involved in dopamine biosynthesis (TH) and metabolism (COMT, MAOA) affect D2 receptor availability in vivo?
This technical protocol describes the procedural aspects of [I-123]IBZM SPECT. It is not intended to be sufficient on its own for a clinical study. All subjects volunteering for this study will be recruited from among individuals who have previously consented to participate in clinical studies under one of two NIH protocols that include genetic testing. Schizophrenia patients will be recruited from among NIMH inpatients participating under NIH protocol #89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients" (Egan 1999a). Normal volunteers will be recruited from among those participating under NIH protocol #95-M-0150, "A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings" (Egan 1999b), which includes recruitment of a normal control group whose first degree relatives are free of mental illness. All details related to clinical care and genetic analysis are contained in those two protocols and their associated consent forms; all details related to [I-123]IBZM SPECT studies, per se, are discussed in this protocol, which requires a separate informed consent from each volunteer.
- Conditions
- Healthy, Schizophrenia
- Keywords
- Parkinson's Disease, Schizophrenia, Dopamine D2/D3 receptors, Brain Imaging, SPECT, Equilibrium, Brain Scan, Brain Research, Brain Disorders, Schizoaffective Disorder, Normal Volunteer
- Medical subject headings
- Schizophrenia, Parkinson Disease, Brain Diseases, Psychotic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startOct 1991
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 265 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001320
- Sponsor's protocol ID
- 920024
- Other IDs
- 92-M-0024
- Status last verified
- Jul 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 9519100Knable 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.
PubMed 9351491Wolf 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.
PubMed 8703056
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-123 Iodobenzamide (IBZM) SPECT Studies of D2 Receptor Distribution and Function in Patients With Schizophrenia and Normal Volunteers
- ClinicalTrials.gov ID
- NCT00001320
- Acronym / sponsor ID
- 920024
- Conditions
- Healthy, Schizophrenia
- Keywords
- Parkinson's Disease, Schizophrenia, Dopamine D2/D3 receptors, Brain Imaging, SPECT, Equilibrium, Brain Scan, Brain Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Oct 1991
- Study completion
- Jul 2003
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Abnormalities in dopaminergic neurotransmission have been described in substance abuse and different neuropsychiatric disorders including schizophrenia. [I-123] IBZM is a radioligand that has been widely employed for SPECT imaging of dopamine type 2 and type 3 receptors (D2 and D3, respectively) and fluctuations in levels of endogenous dopamine. [I-123] IBZM SPECT has been used in the SPECT Lab of the Clinical Brain Disorders Branch for several years without adverse effects. Pharmacological effects of IBZM are unlikely due to the minimal amounts used and have not been observed. We propose to use [I-123] IBZM SPECT to explore following questions: 1) Can a previously found relationship between N-acetylaspartate (NAA) measures in the dorsolateral prefrontal cortex and striatal dopamine activity in patients with schizophrenia be replicated and is it also found in normal subjects? 2) Do allelic variants of genes for the dopamine type 2 (DRD2) and type 3 (DRD3) receptors, the dopamine transporter (SLC6A3), or enzymes involved in dopamine biosynthesis (TH) and metabolism (COMT, MAOA) affect D2 receptor availability in vivo?
This technical protocol describes the procedural aspects of [I-123]IBZM SPECT. It is not intended to be sufficient on its own for a clinical study. All subjects volunteering for this study will be recruited from among individuals who have previously consented to participate in clinical studies under one of two NIH protocols that include genetic testing. Schizophrenia patients will be recruited from among NIMH inpatients participating under NIH protocol #89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients" (Egan 1999a). Normal volunteers will be recruited from among those participating under NIH protocol #95-M-0150, "A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings" (Egan 1999b), which includes recruitment of a normal control group whose first degree relatives are free of mental illness. All details related to clinical care and genetic analysis are contained in those two protocols and their associated consent forms; all details related to [I-123]IBZM SPECT studies, per se, are discussed in this protocol, which requires a separate informed consent from each volunteer.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Prior participation as a NIMH inpatient under NIH protocol #89-M-0160.
- Schizophrenia diagnosis according to DSM-IV criteria.
- Prior participation as a normal volunteer under NIH protocol #95-M-0150.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9519100Knable 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.
- Background: PubMed 9351491Knable 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.
- Background: PubMed 8703056Wolf 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001320, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.