SchizophreniaNCT01036568
Neuroimaging Studies of Neurophysiological Phenotypes in Schizophrenia
An observational study of Schizophrenia and Psychosis, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Background: Eye tracking, the ability to focus on and follow a moving target with the eyes, is often difficult for people who have schizophrenia. Research has shown that first-degree relatives of people with schizophrenia, such as parents and siblings, also tend to have difficulty with smooth eye movement and eye… Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychosis
- How many people
- 121 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2006to 7 Mar 2013
- 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 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Subjects:
- must be 18-62 years of age.
- must be in good general health based on medical history and physical examination.
- Schizophrenic patients:
- must have a DSM-IV diagnosis of schizophrenia.
- must be clinically stable in the opinion of the patient s treating clinician with no change in antipsychotic medications or any dosage adjustment for 2 weeks or more preceding study enrollment as well as 2 weeks or more prior to the MRI scan.
- Relatives of patients:
- 1. must be first degree relatives (full sibling, parent, or offspring)
Who cannot join
- All subjects:
- Individuals who have alcohol and/or marijuana dependence
- Individuals who are pregnant; Urine pregnancy tests will be performed on all female volunteers of childbearing potential before each experimental session.
- Individuals who are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
- Individuals who have major medical illnesses that may affect normal brain functioning or safety lying in the scanner. Examples of these conditions include, but not limited to, stroke, seizure, HIV/AIDS, uncontrolled high blood pressure, history of significant head trauma, CNS infection or tumor based on medical history, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis.
- Individuals who partake in significant alcohol or other drug use, other than nicotine dependence. Significant drug use is defined as a history of alcohol or other substance dependence in the past 6 months or current substance abuse, with the following few exceptions. Subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence.
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- Individuals with significant ophthalmological and/or neurological conditions who have severe vision impairments such that they cannot follow a moving dot 60 cm in front of them are excluded. Participants with reduced vision are included as long as they can follow a moving dot 60 cm in front of them.
- Healthy controls:
- Individuals with psychiatric illness. The SCID and Structured Interview for DSM-IV Personality Diagnoses (SIDP) will be used to exclude volunteers with Axis I and II disorders.
- Individuals with a family history of psychotic illness according to Family History Research Diagnostic Criteria (FH-RDC).
- First Degree Relatives of patients:
- First degree relatives with a DSM-IV Axis I diagnosis of psychosis, with the exception that a relative with a past history of psychosis will be included if symptoms are not present, and he/she is not taking antipsychotic drugs.
- First degree relatives that meet SIDP criteria for an Axis II disorder with exceptions made for relatives meeting criteria for schizophrenia spectrum personality disorders (SSPD).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201-1595
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
Background:
- Eye tracking, the ability to focus on and follow a moving target with the eyes, is often difficult for people who have schizophrenia. Research has shown that first-degree relatives of people with schizophrenia, such as parents and siblings, also tend to have difficulty with smooth eye movement and eye tracking. Researchers are interested in using functional magnetic resonance imaging (fMRI) to study brain activity during eye tracking tests in order to better understand the effect that schizophrenia has on brain function.
Read more
Objectives:
- To study eye-tracking and eye-tracking impairments in people with and without schizophrenia.
Eligibility:
- Individuals between 18 and 62 years of age in one of three groups: (1) patients who have been diagnosed with schizophrenia/schizoaffective disorder, (2) first-degree relatives of patients in group 1, and (3) healthy volunteers with no family history of psychosis.
Design:
- The study will involve two visits, one screening session and one testing session. Each session will take about 3 hours.
- Participants will be asked to avoid consuming alcohol and restrict consumption of caffeine before the start of the study. Participants will provide urine and breath samples to be tested for chemicals that may interfere with the study.
- Participants will visit the clinical center the morning of the day before the scanning session to provide blood and urine samples as required. Participants will return and be admitted for an overnight stay later that afternoon or evening.
- During the screening session, participants will provide a medical and psychological history, provide blood samples, and learn the eye movement tasks they will do during the scanning session.
- During the scanning session, participants will have an fMRI scan. During the scan, they will perform eye movement tasks that involve following moving light targets on a screen, and will also perform other tasks that test the ability to think and pay attention.
Read the detailed description
Objective:
The proposed protocol aims to combine functional magnetic resonance imaging (fMRI) and SPEM eyetracking measures to study 1) the neural circuit controlling the psychophysical, cognitive, and oculomotor aspects of eyetracking; 2) the underlying neural mechanism of schizophrenia-related eyetracking impairments; and 3) the degree to which pursuit-related imaging changes aggregate in families. The human eye movement system is complex. It is likely that only components of the system, rather than the whole system, are involved in the pathology of schizophrenia.
Study Population:
Three groups of subjects will be tested: schizophrenic patients (approximately n=60), full siblings of patients (approximately n=60), and healthy controls without family history of psychosis (approximately n=60). To reach this goal of 60 per group we expect to enroll 225 subjects.
Design:
Experiments in this protocol employ fMRI in combination with psychophysical and oculomotor paradigms to dissect the neural correlates of the neurophysiological components controlling pursuit eye movement. A high-resolution in-magnet eyetracking system will be used during imaging. Using this imaging technology we will be able to associate behavioral performance with specific brain regions.
Outcome Measures:
Combining fMRI and visual neuroscience techniques, this protocol will study the functional neuroanatomic underpinnings of smooth pursuit eye movement (SPEM) deficits in schizophrenia. We aim to establish a pathophysiological model of the illness based on the SPEM paradigm. Such a disease model may provide safe in vivo examination of the effects of pharmacological interventions, comorbidity, and functionality relating to schizophrenia. For example, patients with schizophrenia have high comorbidity of nicotine use. High incidence of substance abuse in schizophrenia suggests that the two conditions may share some common pathophysiology. Excessive nicotine use in schizophrenia is increasingly viewed as a form of self-medication by patients to correct underlying pathophysiological changes caused by the illness. We have found that nicotine can transiently improve smooth pursuit eye movement deficits in patients. We are currently examining the nicotinic effect on the learning components of smooth pursuit eye movement in schizophrenic patients using fMRI. This is an example on how carefully validated behavioral/imaging paradigm can be used as a pathophysiological model in aiding the study of complex brain illness including schizophrenia and substance abuse. Clearly, this research direction also requires a parallel research effort that aims at in-depth understanding of the foundational neural mechanism of the smooth pursuit eye movement itself.
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Psychosis, Smooth Pursuit, Motion Perception, Neurophysiology, fMRI
- Medical subject headings
- Schizophrenia, Psychotic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start14 Feb 2006
- Study completion7 Mar 2013
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 SchizophreniaStudies of the same condition, open and under way.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036568
- Sponsor's protocol ID
- 999906405
- Other IDs
- 06-DA-N405
- Status last verified
- 7 Mar 2013
- First submitted
- 18 Dec 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Andreasen NC, Endicott J, Spitzer RL, Winokur G. The family history method using diagnostic criteria. Reliability and validity. Arch Gen Psychiatry. 1977 Oct;34(10):1229-35. doi: 10.1001/archpsyc.1977.01770220111013.
PubMed 911222Assad JA, Maunsell JH. Neuronal correlates of inferred motion in primate posterior parietal cortex. Nature. 1995 Feb 9;373(6514):518-21. doi: 10.1038/373518a0.
PubMed 7845463Avila MT, Adami HM, McMahon RP, Thaker GK. Using neurophysiological markers of genetic risk to define the boundaries of the schizophrenia spectrum phenotype. Schizophr Bull. 2003;29(2):299-309. doi: 10.1093/oxfordjournals.schbul.a007006.
PubMed 14552505
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Studies of Neurophysiological Phenotypes in Schizophrenia
- ClinicalTrials.gov ID
- NCT01036568
- Acronym / sponsor ID
- 999906405
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Psychosis, Smooth Pursuit, Motion Perception, Neurophysiology, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 14 Feb 2006
- Study completion
- 7 Mar 2013
- First posted
- 21 Dec 2009 (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.
Background:
- Eye tracking, the ability to focus on and follow a moving target with the eyes, is often difficult for people who have schizophrenia. Research has shown that first-degree relatives of people with schizophrenia, such as parents and siblings, also tend to have difficulty with smooth eye movement and eye tracking. Researchers are interested in using functional magnetic resonance imaging (fMRI) to study brain activity during eye tracking tests in order to better understand the effect that schizophrenia has on brain function.
Objectives:
- To study eye-tracking and eye-tracking impairments in people with and without schizophrenia.
Eligibility:
- Individuals between 18 and 62 years of age in one of three groups: (1) patients who have been diagnosed with schizophrenia/schizoaffective disorder, (2) first-degree relatives of patients in group 1, and (3) healthy volunteers with no family history of psychosis.
Design:
- The study will involve two visits, one screening session and one testing session. Each session will take about 3 hours.
- Participants will be asked to avoid consuming alcohol and restrict consumption of caffeine before the start of the study. Participants will provide urine and breath samples to be tested for chemicals that may interfere with the study.
- Participants will visit the clinical center the morning of the day before the scanning session to provide blood and urine samples as required. Participants will return and be admitted for an overnight stay later that afternoon or evening.
- During the screening session, participants will provide a medical and psychological history, provide blood samples, and learn the eye movement tasks they will do during the scanning session.
- During the scanning session, participants will have an fMRI scan. During the scan, they will perform eye movement tasks that involve following moving light targets on a screen, and will also perform other tasks that test the ability to think and pay attention.
Detailed description
Objective:
The proposed protocol aims to combine functional magnetic resonance imaging (fMRI) and SPEM eyetracking measures to study 1) the neural circuit controlling the psychophysical, cognitive, and oculomotor aspects of eyetracking; 2) the underlying neural mechanism of schizophrenia-related eyetracking impairments; and 3) the degree to which pursuit-related imaging changes aggregate in families. The human eye movement system is complex. It is likely that only components of the system, rather than the whole system, are involved in the pathology of schizophrenia.
Study Population:
Three groups of subjects will be tested: schizophrenic patients (approximately n=60), full siblings of patients (approximately n=60), and healthy controls without family history of psychosis (approximately n=60). To reach this goal of 60 per group we expect to enroll 225 subjects.
Design:
Experiments in this protocol employ fMRI in combination with psychophysical and oculomotor paradigms to dissect the neural correlates of the neurophysiological components controlling pursuit eye movement. A high-resolution in-magnet eyetracking system will be used during imaging. Using this imaging technology we will be able to associate behavioral performance with specific brain regions.
Outcome Measures:
Combining fMRI and visual neuroscience techniques, this protocol will study the functional neuroanatomic underpinnings of smooth pursuit eye movement (SPEM) deficits in schizophrenia. We aim to establish a pathophysiological model of the illness based on the SPEM paradigm. Such a disease model may provide safe in vivo examination of the effects of pharmacological interventions, comorbidity, and functionality relating to schizophrenia. For example, patients with schizophrenia have high comorbidity of nicotine use. High incidence of substance abuse in schizophrenia suggests that the two conditions may share some common pathophysiology. Excessive nicotine use in schizophrenia is increasingly viewed as a form of self-medication by patients to correct underlying pathophysiological changes caused by the illness. We have found that nicotine can transiently improve smooth pursuit eye movement deficits in patients. We are currently examining the nicotinic effect on the learning components of smooth pursuit eye movement in schizophrenic patients using fMRI. This is an example on how carefully validated behavioral/imaging paradigm can be used as a pathophysiological model in aiding the study of complex brain illness including schizophrenia and substance abuse. Clearly, this research direction also requires a parallel research effort that aims at in-depth understanding of the foundational neural mechanism of the smooth pursuit eye movement itself.
Study design
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- must be 18-62 years of age.
- must be in good general health based on medical history and physical examination.
- must have a DSM-IV diagnosis of schizophrenia.
- must be clinically stable in the opinion of the patient s treating clinician with no change in antipsychotic medications or any dosage adjustment for 2 weeks or more preceding study enrollment as well as 2 weeks or more prior to the MRI scan.
- 1. must be first degree relatives (full sibling, parent, or offspring)
Key exclusion criteria (13 listed)
- Individuals who have alcohol and/or marijuana dependence
- Individuals who are pregnant; Urine pregnancy tests will be performed on all female volunteers of childbearing potential before each experimental session.
- Individuals who are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
- Individuals who have major medical illnesses that may affect normal brain functioning or safety lying in the scanner. Examples of these conditions include, but not limited to, stroke, seizure, HIV/AIDS, uncontrolled high blood pressure, history of significant head trauma, CNS infection or tumor based on medical history, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis.
- Individuals who partake in significant alcohol or other drug use, other than nicotine dependence. Significant drug use is defined as a history of alcohol or other substance dependence in the past 6 months or current substance abuse, with the following few exceptions. Subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence.
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 5 Apr 2018.
- Background: PubMed 911222Andreasen NC, Endicott J, Spitzer RL, Winokur G. The family history method using diagnostic criteria. Reliability and validity. Arch Gen Psychiatry. 1977 Oct;34(10):1229-35. doi: 10.1001/archpsyc.1977.01770220111013.
- Background: PubMed 7845463Assad JA, Maunsell JH. Neuronal correlates of inferred motion in primate posterior parietal cortex. Nature. 1995 Feb 9;373(6514):518-21. doi: 10.1038/373518a0.
- Background: PubMed 14552505Avila MT, Adami HM, McMahon RP, Thaker GK. Using neurophysiological markers of genetic risk to define the boundaries of the schizophrenia spectrum phenotype. Schizophr Bull. 2003;29(2):299-309. doi: 10.1093/oxfordjournals.schbul.a007006.
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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.
Elliot Stein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Psychosis, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 8 inclusion and 13 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 NCT01036568, 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 5 Apr 2018.