Brain InjuryNCT00001323
Neuropsychiatric Evaluation of Healthy Volunteers and Adults With Schizophrenia
An observational study of Brain Injury and Dementia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the cognitive processes of participants with schizophrenia, participants with nervous system and mental disorders, and healthy volunteers. Participants in this study will undergo cognitive tests of attention, memory, attention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Injury, Dementia, Healthy
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1992to Aug 2005
- 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
- English-speaking adults between ages 21 to 65, in good health and free from significant substance abuse.
- Children between ages 4 to 20 must not have a history of special education, using psychotropic medication in long-term counseling or with a history of seizures, head injury or CNS infections.
- Normal controls will be recruited and screened for exclusionary morbidity by interview (e.g., no history of contact with mental health professionals, no history of diagnosable alcohol and/or substance abuse).
- Normal controls will be recruited from building employees, local universities, from NIMH rosters, and the general public.
Who cannot join
- Excluded are adults with histories of dementing illness, movement disorder, affective disorders, developmental and/or acquired brain injury. Diagnoses will be made by review of medical records, interview, examination, and in the case of psychiatric diagnoses, a structured interview by SCID.
- Advertisement will make clear that the subjects will be asked questions about family psychiatric history and their own history or psychiatric disorder, substance abuse, and neurological disease. Only if the subject answers these negatively will he or she participate in this study.
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: Neuropsychiatric Evaluation of Normal Subjects and Psychiatric and Neurologic Contrast Groups
The purpose of this study is to evaluate the cognitive processes of participants with schizophrenia, participants with nervous system and mental disorders, and healthy volunteers.
Participants in this study will undergo cognitive tests of attention, memory, attention. Participants with attention deficit hyperactivity disorder (ADHD), traumatic brain injury (TBI), bipolar disorder, and Alzheimer's disease (AD) will be compared with participants with schizophrenia. A group of healthy adults and children will undergo cognitive tests to further delineate the degree of impairment in schizophrenia and neurological disorder participants.
Read the detailed description
In this study, we propose to administer cognitive tests to schizophrenic patients and to neurologic patients who will serve as contrast groups for neuropsychological studies of patients with schizophrenia. These include studies of Alzheimers disease to dissociate size and organization of lexicon and ADHD to understand error patterns on CPT-type tests of attention and vigilance. However, the majority of studies will examine schizophrenia in relation to normal controls.
In addition, we propose to obtain test results from a local sample of normal subjects of varying ages and educational backgrounds to further delineate degree of impairment in these clinical groups. As well as assessing adults we wish to assess normal children. In particular, we wish to identify in children the size of their lexicon and their degree of semantic organization within their lexicon.
- Conditions
- Brain Injury, Dementia, Healthy, Mental Disorder, Schizophrenia
- Keywords
- Cognition, Neuropsychology, Neuropsychological Tests, Neurological Exam, Psychiatric, Attention, Schizophrenic, Schizoaffective, Working Memory, Memory
- Medical subject headings
- Brain Injuries, Dementia, Mental Disorders, Schizophrenia
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 startAug 1992
- Study completionAug 2005
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 Brain InjuryStudies 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
- 810 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
- NCT00001323
- Sponsor's protocol ID
- 920262
- Other IDs
- 92-M-0262
- Status last verified
- Aug 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Goldberg TE, Weinberger DR, Berman KF, Pliskin NH, Podd MH. Further evidence for dementia of the prefrontal type in schizophrenia? A controlled study of teaching the Wisconsin Card Sorting Test. Arch Gen Psychiatry. 1987 Nov;44(11):1008-14. doi: 10.1001/archpsyc.1987.01800230088014.
PubMed 3675128Seidman LJ. Schizophrenia and brain dysfunction: an integration of recent neurodiagnostic findings. Psychol Bull. 1983 Sep;94(2):195-238. No abstract available.
PubMed 6356196Weinberger DR, Berman KF, Zec RF. Physiologic dysfunction of dorsolateral prefrontal cortex in schizophrenia. I. Regional cerebral blood flow evidence. Arch Gen Psychiatry. 1986 Feb;43(2):114-24. doi: 10.1001/archpsyc.1986.01800020020004.
PubMed 3947207
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
- Neuropsychiatric Evaluation of Normal Subjects and Psychiatric and Neurologic Contrast Groups
- ClinicalTrials.gov ID
- NCT00001323
- Acronym / sponsor ID
- 920262
- Conditions
- Brain Injury, Dementia, Healthy, Mental Disorder, Schizophrenia
- Keywords
- Cognition, Neuropsychology, Neuropsychological Tests, Neurological Exam, Psychiatric, Attention, Schizophrenic, Schizoaffective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 810 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Aug 1992
- Study completion
- Aug 2005
- 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.
The purpose of this study is to evaluate the cognitive processes of participants with schizophrenia, participants with nervous system and mental disorders, and healthy volunteers.
Participants in this study will undergo cognitive tests of attention, memory, attention. Participants with attention deficit hyperactivity disorder (ADHD), traumatic brain injury (TBI), bipolar disorder, and Alzheimer's disease (AD) will be compared with participants with schizophrenia. A group of healthy adults and children will undergo cognitive tests to further delineate the degree of impairment in schizophrenia and neurological disorder participants.
Detailed description
In this study, we propose to administer cognitive tests to schizophrenic patients and to neurologic patients who will serve as contrast groups for neuropsychological studies of patients with schizophrenia. These include studies of Alzheimers disease to dissociate size and organization of lexicon and ADHD to understand error patterns on CPT-type tests of attention and vigilance. However, the majority of studies will examine schizophrenia in relation to normal controls.
In addition, we propose to obtain test results from a local sample of normal subjects of varying ages and educational backgrounds to further delineate degree of impairment in these clinical groups. As well as assessing adults we wish to assess normal children. In particular, we wish to identify in children the size of their lexicon and their degree of semantic organization within their lexicon.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking adults between ages 21 to 65, in good health and free from significant substance abuse.
- Children between ages 4 to 20 must not have a history of special education, using psychotropic medication in long-term counseling or with a history of seizures, head injury or CNS infections.
- Normal controls will be recruited and screened for exclusionary morbidity by interview (e.g., no history of contact with mental health professionals, no history of diagnosable alcohol and/or substance abuse).
- Normal controls will be recruited from building employees, local universities, from NIMH rosters, and the general public.
Key exclusion criteria (2 listed)
- Excluded are adults with histories of dementing illness, movement disorder, affective disorders, developmental and/or acquired brain injury. Diagnoses will be made by review of medical records, interview, examination, and in the case of psychiatric diagnoses, a structured interview by SCID.
- Advertisement will make clear that the subjects will be asked questions about family psychiatric history and their own history or psychiatric disorder, substance abuse, and neurological disease. Only if the subject answers these negatively will he or she participate in 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 3675128Goldberg TE, Weinberger DR, Berman KF, Pliskin NH, Podd MH. Further evidence for dementia of the prefrontal type in schizophrenia? A controlled study of teaching the Wisconsin Card Sorting Test. Arch Gen Psychiatry. 1987 Nov;44(11):1008-14. doi: 10.1001/archpsyc.1987.01800230088014.
- Background: PubMed 6356196Seidman LJ. Schizophrenia and brain dysfunction: an integration of recent neurodiagnostic findings. Psychol Bull. 1983 Sep;94(2):195-238. No abstract available.
- Background: PubMed 3947207Weinberger DR, Berman KF, Zec RF. Physiologic dysfunction of dorsolateral prefrontal cortex in schizophrenia. I. Regional cerebral blood flow evidence. Arch Gen Psychiatry. 1986 Feb;43(2):114-24. doi: 10.1001/archpsyc.1986.01800020020004.
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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.
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 Brain Injury and Dementia, 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 4 inclusion and 2 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 NCT00001323, 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.