Brain Cell Injury in Patients With A First Episode of Psychosis

Completed

• Conditions: Psychoses

• Registration Number: NCT00070889
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2003-10-09
• Study First Submitted QC: 2003-10-10
• Study First Posted: 2003-10-13
• Study Completion: 2004-08
• Status Verified: 2006-07
• Last Update Submitted: 2006-08-17
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Medical College of Georgia; 🇺🇸 Augusta, Georgia, United States