Anxiety DisorderNCT00001192
Neuropsychological Evaluation of Psychiatric and Neurological Patients
An observational study of Anxiety Disorder and Head Injury, run by National Institute of Mental Health (NIMH) at 7 sites in 3 countries.
Trial summary
This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as "batteries" will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and… Read more about this study
- Who is it for?
- Ages Up to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Head Injury, Mood Disorder
- How many people
- 4,300 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 18 Oct 1983to 20 Dec 2006
- 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 Up to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients.
- Normal volunteers.
Who cannot join
- Subjects over 95 years of age.
- Subjects with a history of alcohol or drug abuse, psychopathology, or central nervous system pathology, other than that which defines group membership, may be excluded.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Henry Ford Health Systems
Detroit, Michigan, 48202
Mt. Sinai Medical Center
New York, New York, 10029-0574
Columbia University
New York, New York, 10032-3784
Childrens National Medical Center
Washington D.C., District of Columbia
About this study
This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as "batteries" will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and perceptual functions, vigilance (alertness), and visual-spatial functions. Children and adult patient will receive different test batteries.
The goals of this research study are to;
- Create descriptions based on the performance of each patient on the test batteries. Then use this information to relate patient behavior to their neurophysiological, neuroradiological, and biochemical descriptions.
- Define subgroups of patients based on their neurobehavior in order to decrease the variability of psychiatric diagnoses, treatments, and prognoses.
Read the detailed description
Neuropsychological tests are used to provide an assessment of cognitive functions in patients with idiopathic generalized epileptic (IGE) disorders and their first-degree relatives. The battery comprises tests designed to tap attention, memory, selected sensory and perceptual functions, vigilance, and visual-spatial functions. Modified batteries have been developed for the assessment of children ages 5-8, and children ages 8-16. The data provided by these batteries are compared with genetic profiles of the same participants that have been ascertained from blood samples analyzed by colleagues at the Mount Sinai School of Medicine/Columbia University in New York City.
- Conditions
- Anxiety Disorder, Head Injury, Mood Disorder, Schizophrenia, Seizures
- Keywords
- Executive Functions, Language, Attention, Visual-Spatial Ability, Memory, Motor Behavior, Intelligence, Personality, Visual and Auditory Functioning, Hand and Eye Dominance, Normal Volunteer, Neuropsychiatric Disorders
- Medical subject headings
- Anxiety Disorders, Craniocerebral Trauma, Mood Disorders, Schizophrenia, Seizures, Language, Motor Activity
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 start18 Oct 1983
- Study completion20 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies 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
- 4,300 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
- NCT00001192
- Sponsor's protocol ID
- 830176
- Other IDs
- 83-M-0176
- Status last verified
- 20 Dec 2006
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Johnstone EC, Owens DG, Bydder GM, Colter N, Crow TJ, Frith CD. The spectrum of structural brain changes in schizophrenia: age of onset as a predictor of cognitive and clinical impairments and their cerebral correlates. Psychol Med. 1989 Feb;19(1):91-103. doi: 10.1017/s0033291700011053.
PubMed 2727213
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Evaluation of Psychiatric and Neurological Patients
- ClinicalTrials.gov ID
- NCT00001192
- Acronym / sponsor ID
- 830176
- Conditions
- Anxiety Disorder, Head Injury, Mood Disorder, Schizophrenia, Seizures
- Keywords
- Executive Functions, Language, Attention, Visual-Spatial Ability, Memory, Motor Behavior, Intelligence, Personality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,300 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 18 Oct 1983
- Study completion
- 20 Dec 2006
- 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.
This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as "batteries" will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and perceptual functions, vigilance (alertness), and visual-spatial functions. Children and adult patient will receive different test batteries.
The goals of this research study are to;
- Create descriptions based on the performance of each patient on the test batteries. Then use this information to relate patient behavior to their neurophysiological, neuroradiological, and biochemical descriptions.
- Define subgroups of patients based on their neurobehavior in order to decrease the variability of psychiatric diagnoses, treatments, and prognoses.
Detailed description
Neuropsychological tests are used to provide an assessment of cognitive functions in patients with idiopathic generalized epileptic (IGE) disorders and their first-degree relatives. The battery comprises tests designed to tap attention, memory, selected sensory and perceptual functions, vigilance, and visual-spatial functions. Modified batteries have been developed for the assessment of children ages 5-8, and children ages 8-16. The data provided by these batteries are compared with genetic profiles of the same participants that have been ascertained from blood samples analyzed by colleagues at the Mount Sinai School of Medicine/Columbia University in New York City.
Study design
Who may qualify
- Ages
- Up to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients.
- Normal volunteers.
Key exclusion criteria (2 listed)
- Subjects over 95 years of age.
- Subjects with a history of alcohol or drug abuse, psychopathology, or central nervous system pathology, other than that which defines group membership, may be excluded.
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 2 Jul 2017.
- Background: PubMed 2727213Johnstone EC, Owens DG, Bydder GM, Colter N, Crow TJ, Frith CD. The spectrum of structural brain changes in schizophrenia: age of onset as a predictor of cognitive and clinical impairments and their cerebral correlates. Psychol Med. 1989 Feb;19(1):91-103. doi: 10.1017/s0033291700011053.
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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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder and Head Injury, run by National Institute of Mental Health (NIMH) at 7 sites in 3 countries.
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 2 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 2 Jul 2017. 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, France, Russia. 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 NCT00001192, which also lists 1 linked publication.
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 2 Jul 2017.