Viewing Study NCT00070889



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00070889
Status: COMPLETED
Last Update Posted: 2006-08-18
First Post: 2003-10-09

Brief Title: Brain Cell Injury in Patients With A First Episode of Psychosis
Sponsor: National Center for Complementary and Integrative Health NCCIH
Organization: National Center for Complementary and Integrative Health NCCIH

Study Overview

Official Title: Oxidative Cell Injury First Episode Psychotic Patients
Status: COMPLETED
Status Verified Date: 2006-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None