SchizophreniaNCT00666146
Familial Schizophrenia and Spectrum Personality Disorders
An observational study of Schizophrenia, run by University of Maryland, Baltimore at 3 sites in United States.
Trial summary
We propose to recruit 150 case families (i.e., families with a schizophrenia proband), 150 control families, and 45 control subjects who exhibit schizophrenia spectrum personality symptoms in the absence of a family history of schizophrenia. Read more about this study
- Who is it for?
- Ages 16 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 539 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to Jan 2020
- 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 16 to 58 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: University of Maryland, Baltimore: Enrolling by Invitation
Who may be able to join
- All male and female participants must be age 16 and above.
- Case probands will include individuals who meet DSM-IV criteria for schizophrenia or Research Diagnostic Criteria (RDC) for schizoaffective disorder.
- Control probands will include individuals matched with case probands with respect to age, gender, and county of residence who do not meet DSM-IV criteria for schizophrenia or other psychotic disorders.
- Case and control relatives will include all available and age-eligible first-degree relatives of identified case and control probands. Exception to this criterion will occur if we identify a schizophrenia proband family of large pedigree willing to participate, then we will include several generations of relatives (second, third or more degree) for subsequent linkage studies in a subgroup of our sample.
- SSP controls will include individuals recruited from the community who exhibit schizophrenia spectrum personality (SSP) traits in the absence of a personal or family history of psychotic illness.
Who cannot join
- Subjects under 16 years of age will be excluded.
- Subjects with serious medical, neuro-ophthalmological or neurological illness (e.g., cancer,seizure disorders,encephalopathy), current substance abuse or extensive history or drug dependence will be excluded, with the exception of subjects participating for clinical interview and blood sample only.
- Subjects with mental retardation will be excluded.
- Control probands and SSP controls who meet DSM-IV criteria for a psychotic illness, or have a family history of psychotic illness will be excluded.
- Schizophrenic patients who are judged to be incompetent to provide voluntary informed consent based on the ESC evaluation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Community Mental Health Centers
Baltimore, Maryland, 21201
VA Medical Center
Baltimore, Maryland, 21201
University of Maryland, Baltimore
Catonsville, Maryland, 21228
About this study
We propose to recruit 150 case families (i.e., families with a schizophrenia proband), 150 control families, and 45 control subjects who exhibit schizophrenia spectrum personality symptoms in the absence of a family history of schizophrenia. Participants will undergo a number of clinical, electrophysiological, perceptual, and cognitive assessments. These data will be used to identify phenotypes likely to be associated with genetic risk for schizophrenia, and to determine how these phenotypes aggregate in families. Some of the analyses will focus on examining associations between candidate genes and these alternative phenotypes. Thus if we are not able to recruit relatives we may still collect these phenotypic data in probands and their genetic sample for future genotype/phenotype association studies. Testing procedures require a 10-12 hour time commitment and testing will be completed over 2 or more days. Participants will be asked to give a blood (or saliva if difficult to obtain blood sample for instance because of fear of blood draws), which will be stored for future genetic analyses.
Read the detailed description
Specific aims of the proposed study are:
- To test the hypothesis that abnormalities in predictive pursuit, antisaccade performance, working memory, visual attention (CPT), sensory gating (PPI and P50) and other measures of information processing mark the liability for schizophrenia. Secondly, we will examine the pattern of familial aggregation of these measures to determine whether observed deficits are likely to reflect genetic and/or environmental effects. The hypothesis will be supported if (a) the frequency of these neurophysiological deficits is higher in relatives of schizophrenic probands than in relatives of control probands; (b) the prevalence of neurophysiological abnormalities is higher in case relatives with SSP symptoms than in nonSSP case relatives; (c) risk is increased among case relatives of "affected" probands vs. case relatives of "unaffected" probands (i.e., risk in relatives of case probands who exhibit an abnormality vs. relatives of case probands who do not).
- To test the hypothesis that some physiological deficits reflect a common underlying phenotype, while others mark independent aspects of disease risk. To test this hypothesis (a) we will examine correlation matrices (adjusted for within family correlation) for neurophysiological assessments among case relatives and control relatives. Factor structures in the two groups will be examined using exploratory factor analyses, followed by confirmatory factor analyses using validation samples of case/control relatives. Confirmatory Factor Analyses (CFA) will also be used to determine how factor solutions based on case/control relatives fit the data of case probands. (b) Factor scores for correlated measures will be derived and the familial risk for composite measures of neurophysiological functioning estimated using the methods described in Specific Aim 1. (c) Secondary within family analyses will be performed to estimate the heritability of derived factor scores and to determine whether patterns of familial correlations suggest a genetic or environmental cause.
- To evaluate whether particular domains of psychopathology are marked by different putative phenotypic markers. We will specifically test the hypotheses that predictive pursuit, working memory, and sensory gating measures are more strongly associated with positive psychotic symptoms, while smooth pursuit initiation and processing speed measures are more strongly associated with primary negative symptoms. The relationships between clinical domains and other measures or clusters will be examined in an exploratory hypothesis-generating framework.
- We propose to collect blood samples (or rarely saliva sample) from each participant to be stored for future association studies, as well as formal linkage analyses using phenotypes identified in specific aims 1 and 2.
- We plan to examine how nicotine dependence may run in families and to examine if patterns of nicotine use may be related to a family history of schizophrenia. Participants will be asked about their smoking history and current smoking habits. Current smokers will be asked more specific questions about their smoking behaviors to estimate level of current nicotine dependence. It is hoped that this information will give us clues about why so many individuals with schizophrenia smoke.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Genetics, Eyetracking
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Case Families ( Family with a schizophrenia proband) | |
| 2 | Control Families | |
| 3 | Control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component evoked potential; genetic markers
Measured: 12-16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJul 2004
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Observational model
- Family based
- Time perspective
- Other
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- James Gold, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666146
- Sponsor's protocol ID
- HP-00042566
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2008
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Schizophrenia and Spectrum Personality Disorders
- ClinicalTrials.gov ID
- NCT00666146
- Acronym / sponsor ID
- HP-00042566
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Genetics, Eyetracking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2004
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 24 Apr 2008 (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.
We propose to recruit 150 case families (i.e., families with a schizophrenia proband), 150 control families, and 45 control subjects who exhibit schizophrenia spectrum personality symptoms in the absence of a family history of schizophrenia. Participants will undergo a number of clinical, electrophysiological, perceptual, and cognitive assessments. These data will be used to identify phenotypes likely to be associated with genetic risk for schizophrenia, and to determine how these phenotypes aggregate in families. Some of the analyses will focus on examining associations between candidate genes and these alternative phenotypes. Thus if we are not able to recruit relatives we may still collect these phenotypic data in probands and their genetic sample for future genotype/phenotype association studies. Testing procedures require a 10-12 hour time commitment and testing will be completed over 2 or more days. Participants will be asked to give a blood (or saliva if difficult to obtain blood sample for instance because of fear of blood draws), which will be stored for future genetic analyses.
Detailed description
Specific aims of the proposed study are:
- To test the hypothesis that abnormalities in predictive pursuit, antisaccade performance, working memory, visual attention (CPT), sensory gating (PPI and P50) and other measures of information processing mark the liability for schizophrenia. Secondly, we will examine the pattern of familial aggregation of these measures to determine whether observed deficits are likely to reflect genetic and/or environmental effects. The hypothesis will be supported if (a) the frequency of these neurophysiological deficits is higher in relatives of schizophrenic probands than in relatives of control probands; (b) the prevalence of neurophysiological abnormalities is higher in case relatives with SSP symptoms than in nonSSP case relatives; (c) risk is increased among case relatives of "affected" probands vs. case relatives of "unaffected" probands (i.e., risk in relatives of case probands who exhibit an abnormality vs. relatives of case probands who do not).
- To test the hypothesis that some physiological deficits reflect a common underlying phenotype, while others mark independent aspects of disease risk. To test this hypothesis (a) we will examine correlation matrices (adjusted for within family correlation) for neurophysiological assessments among case relatives and control relatives. Factor structures in the two groups will be examined using exploratory factor analyses, followed by confirmatory factor analyses using validation samples of case/control relatives. Confirmatory Factor Analyses (CFA) will also be used to determine how factor solutions based on case/control relatives fit the data of case probands. (b) Factor scores for correlated measures will be derived and the familial risk for composite measures of neurophysiological functioning estimated using the methods described in Specific Aim 1. (c) Secondary within family analyses will be performed to estimate the heritability of derived factor scores and to determine whether patterns of familial correlations suggest a genetic or environmental cause.
- To evaluate whether particular domains of psychopathology are marked by different putative phenotypic markers. We will specifically test the hypotheses that predictive pursuit, working memory, and sensory gating measures are more strongly associated with positive psychotic symptoms, while smooth pursuit initiation and processing speed measures are more strongly associated with primary negative symptoms. The relationships between clinical domains and other measures or clusters will be examined in an exploratory hypothesis-generating framework.
- We propose to collect blood samples (or rarely saliva sample) from each participant to be stored for future association studies, as well as formal linkage analyses using phenotypes identified in specific aims 1 and 2.
- We plan to examine how nicotine dependence may run in families and to examine if patterns of nicotine use may be related to a family history of schizophrenia. Participants will be asked about their smoking history and current smoking habits. Current smokers will be asked more specific questions about their smoking behaviors to estimate level of current nicotine dependence. It is hoped that this information will give us clues about why so many individuals with schizophrenia smoke.
Study design
- Observational model
- Family based
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Case Families ( Family with a schizophrenia proband) |
| 2 | – | –Control Families |
| 3 | – | –Control subjects |
Who may qualify
- Ages
- 16 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- University of Maryland, Baltimore: Enrolling by Invitation
Key inclusion criteria (5 listed)
- All male and female participants must be age 16 and above.
- Case probands will include individuals who meet DSM-IV criteria for schizophrenia or Research Diagnostic Criteria (RDC) for schizoaffective disorder.
- Control probands will include individuals matched with case probands with respect to age, gender, and county of residence who do not meet DSM-IV criteria for schizophrenia or other psychotic disorders.
- Case and control relatives will include all available and age-eligible first-degree relatives of identified case and control probands. Exception to this criterion will occur if we identify a schizophrenia proband family of large pedigree willing to participate, then we will include several generations of relatives (second, third or more degree) for subsequent linkage studies in a subgroup of our sample.
- SSP controls will include individuals recruited from the community who exhibit schizophrenia spectrum personality (SSP) traits in the absence of a personal or family history of psychotic illness.
Key exclusion criteria (5 listed)
- Subjects under 16 years of age will be excluded.
- Subjects with serious medical, neuro-ophthalmological or neurological illness (e.g., cancer,seizure disorders,encephalopathy), current substance abuse or extensive history or drug dependence will be excluded, with the exception of subjects participating for clinical interview and blood sample only.
- Subjects with mental retardation will be excluded.
- Control probands and SSP controls who meet DSM-IV criteria for a psychotic illness, or have a family history of psychotic illness will be excluded.
- Schizophrenic patients who are judged to be incompetent to provide voluntary informed consent based on the ESC evaluation
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
Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component evoked potential; genetic markers
Time frame: 12-16 hours
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 3 May 2021.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
James Gold, M.D. principal investigator
University of Maryland, Baltimore
3 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, run by University of Maryland, Baltimore at 3 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 5 inclusion and 5 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component evoked potential; genetic markers (time frame: 12-16 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2021.