Brain Cell Injury in Patients With A First Episode of Psychosis

Psychoses Clinical Trial

Official title:

Oxidative Cell Injury: First Episode Psychotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070889
• Other study ID #: R01AT000147-01
• Status: Completed
• Phase: N/A
• First received: October 9, 2003
• Last updated: August 17, 2006
• Start date: September 1999
• Est. completion date: August 2004

Study information

• Verified date: July 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

Inclusion Criteria

• Patients must meet clinical diagnostic criteria for psychosis

• Healthy (control) volunteers must not have any family history of mental illness

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Mental Disorders
• Psychoses
• Psychotic Disorders

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,