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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | August 1992 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001323 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Neuropsychiatric Evaluation of Healthy Volunteers and Adults With Schizophrenia |
| Official Title ICMJE | Neuropsychiatric Evaluation of Normal Subjects and Psychiatric and Neurologic Contrast Groups |
| Brief 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. 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 810 |
| Completion Date | August 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001323 |
| Responsible Party | |
| Study ID Numbers ICMJE | 920262, 92-M-0262 |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | August 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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