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| Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00070889 |
Purpose
Patients experiencing a first episode of psychosis may have brain cell damage due to a chemical process called oxidation. This study will compare patients with psychosis to healthy volunteers to determine if there are differences in their blood that reflect oxidative brain cell damage.
| Condition |
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Psychoses |
| MedlinePlus related topics: | Psychotic Disorders |
| Study Type: | Observational |
| Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Oxidative Cell Injury: First Episode Psychotic Patients |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | August 2004 |
Preliminary research indicated that impaired antioxidant defense and increased lipid peroxidation is associated with brain changes during the onset of psychosis. Oxidative cell injury may contribute to poor outcomes in some patients. This study will define the extent and nature of oxidative cell injury that is associated with psychopathology at the onset of psychosis.
Participants in this study will be patients at the D. D. Eisenhower Army Medical Center who are experiencing a psychotic episode for the first time. Patients will be compared with 40 healthy volunteers (control group) matched with patients for age, gender, education, ethnic background, and occupational status. Patients and volunteers will have blood tests to determine the level of oxidative cell injury. Tests will be performed at onset of psychosis, and after 6 and 12 weeks of neuroleptic drug treatment. Medical histories and MRI scans will be used to examine the relationship of the laboratory tests to the clinical presentation.
Eligibility
| Ages Eligible for Study: | 12 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Contacts and Locations More Information
| Study ID Numbers: | R01 AT000147-01 |
| First Received: | October 9, 2003 |
| Last Updated: | August 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00070889 |
| Health Authority: | United States: Federal Government |
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