SchizophreniaNCT00247637
The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia
An observational study of Schizophrenia, run by University of California, San Diego at 7 sites in United States.
Trial summary
This is a study of the genetic basis of brain dysfunction in people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 2,025 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2003to Sep 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject population will include schizophrenia probands (12 per site per year), first degree relatives (36 per site per year) and normal comparison subjects (15 per site per year). The proband must meet the diagnosis of schizophrenia by DSM-IV criteria. There must be at least one parent and one unaffected sibling in the pedigree. Therefore a total of 315 subjects will be enrolled at each site each year with a total of 2205 enrolled across all 7 sites. Schizophrenia probands and normal subjects will be between 18 and 65 years of age. Exclusion criteria include visual or hearing impairments, history of head trauma, organic brain dysfunction, neurological disease, and significant drug or alcohol use and for controls, significant psychiatric history and/or current use of psychotropic medications. We will include equal numbers of men and women and all appropriate subjects willing to participate regardless of ethnic background.
Who may be able to join
- Families with at least one member who has schizophrenia
Who cannot join
- N/A
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Harvard University
Boston, Massachusetts, 02115
University of Colorado Health Sciences Center
Denver, Colorado, 80220
University of California Los Angeles
Los Angeles, California, 90073
Mount Sinai School of Medicine
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, San Diego
San Diego, California, 92103
University of Washington and VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: The Genetics of Endophenotypes and Schizophrenia
This is a study of the genetic basis of brain dysfunction in people with schizophrenia.
Read the detailed description
Schizophrenia is a disabling disorder that is associated with specific inheritable neurobiologic deficits. These deficits can cause problems with memory, visual attention, information processing, and other aspects of daily living. Understanding the genetic components of these deficits in people with schizophrenia and their unaffected family members may help uncover the neurobiological basis, risk factors, and heritability of the disease. In addition, the information may serve to create more effective treatments and possibly a cure for the disease. This study will serve to provide information about the genetic basis of known inherited neurobiological deficits in people with schizophrenia. In turn, this may guide further studies on the genetics of schizophrenia.
Participants will attend 2 study visits, each of which will last approximately 4 hours. The first will include blood tests and diagnostic interviews of participating families to evaluate the presence of schizophrenic symptoms. The second study visit will entail four neurocognitive and neurophysiological tests. Participants will first have a pre-pulse inhibition test, which uses electrodes to measure eye blinking. Electrodes will also be placed on participants' head, ears, and around their eyes to measure brain waves. Next, participants will undergo an oculomotor test, during which they will wear glasses fitted with sensors that record eye movement. Participants will then be asked to repeat a list of words, letters, and numbers read by a researcher. Last, participants will undergo a computerized performance test requiring them to watch the computer screen and click a mouse whenever they see a number between 0 and 9. Each study visit will take approximately 4 hours.
- Conditions
- Schizophrenia
- Keywords
- Mental Health, Psychosis, Genetics, Heredity
- Medical subject headings
- Schizophrenia, Psychological Well-Being, Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score
The primary outcome measure for each endophenotype is as follows: for prepulse inhibition (PPI) the primary measure is the percent inhibition to the 60 msec prepulse; for P50 suppression it is the difference in amplitude between the test and conditioning stimuli; for antisaccade it is the proportion of correct saccades; for the DS-CPT it is (d') which is based on correct target detections and incorrect responses to nontargets; for LNS it is the number correct in the reorder condition; for CVLT it is the total recall score summed across 5 trials.
Measured: Upon entry to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startMay 2003
- Primary completionSep 2008
- Study completionSep 2008
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 California, San DiegoThe 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
- Cross-sectional
- Enrolment
- 2,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dr. David Braff, University of California, San Diego
- Investigators
- David Braff, MD, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247637
- Sponsor's protocol ID
- R01MH065571
- Other IDs
- R01MH065571, R01MH065707, R01MH065578, R01MH065588, R01MH065554, R01MH065562, DNBBS 7G-GRR
- Status last verified
- Jul 2013
- First submitted
- 31 Oct 2005
- Last updated
- 3 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetics of Endophenotypes and Schizophrenia
- ClinicalTrials.gov ID
- NCT00247637
- Acronym / sponsor ID
- R01MH065571
- Conditions
- Schizophrenia
- Keywords
- Mental Health, Psychosis, Genetics, Heredity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,025 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Nov 2005 (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.
This is a study of the genetic basis of brain dysfunction in people with schizophrenia.
Detailed description
Schizophrenia is a disabling disorder that is associated with specific inheritable neurobiologic deficits. These deficits can cause problems with memory, visual attention, information processing, and other aspects of daily living. Understanding the genetic components of these deficits in people with schizophrenia and their unaffected family members may help uncover the neurobiological basis, risk factors, and heritability of the disease. In addition, the information may serve to create more effective treatments and possibly a cure for the disease. This study will serve to provide information about the genetic basis of known inherited neurobiological deficits in people with schizophrenia. In turn, this may guide further studies on the genetics of schizophrenia.
Participants will attend 2 study visits, each of which will last approximately 4 hours. The first will include blood tests and diagnostic interviews of participating families to evaluate the presence of schizophrenic symptoms. The second study visit will entail four neurocognitive and neurophysiological tests. Participants will first have a pre-pulse inhibition test, which uses electrodes to measure eye blinking. Electrodes will also be placed on participants' head, ears, and around their eyes to measure brain waves. Next, participants will undergo an oculomotor test, during which they will wear glasses fitted with sensors that record eye movement. Participants will then be asked to repeat a list of words, letters, and numbers read by a researcher. Last, participants will undergo a computerized performance test requiring them to watch the computer screen and click a mouse whenever they see a number between 0 and 9. Each study visit will take approximately 4 hours.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will include schizophrenia probands (12 per site per year), first degree relatives (36 per site per year) and normal comparison subjects (15 per site per year). The proband must meet the diagnosis of schizophrenia by DSM-IV criteria. There must be at least one parent and one unaffected sibling in the pedigree. Therefore a total of 315 subjects will be enrolled at each site each year with a total of 2205 enrolled across all 7 sites. Schizophrenia probands and normal subjects will be between 18 and 65 years of age. Exclusion criteria include visual or hearing impairments, history of head trauma, organic brain dysfunction, neurological disease, and significant drug or alcohol use and for controls, significant psychiatric history and/or current use of psychotropic medications. We will include equal numbers of men and women and all appropriate subjects willing to participate regardless of ethnic background.
Key inclusion criteria (1 listed)
- Families with at least one member who has schizophrenia
Key exclusion criteria (1 listed)
- N/A
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
percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score
Time frame: Upon entry to the study
The primary outcome measure for each endophenotype is as follows: for prepulse inhibition (PPI) the primary measure is the percent inhibition to the 60 msec prepulse; for P50 suppression it is the difference in amplitude between the test and conditioning stimuli; for antisaccade it is the proportion of correct saccades; for the DS-CPT it is (d') which is based on correct target detections and incorrect responses to nontargets; for LNS it is the number correct in the reorder condition; for CVLT it is the total recall score summed across 5 trials.
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 Jul 2013.
- Click here for more information on the Schizophrenia Research ProgramLink provided by the sponsor.
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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.
David Braff, MD study director
University of California, San Diego
7 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 California, San Diego at 7 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 1 inclusion and 1 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 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score (time frame: Upon entry to the study). 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 Jul 2013.