PsychosesNCT00070889
Brain Cell Injury in Patients With A First Episode of Psychosis
An observational study of Psychoses, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychoses
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Aug 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients must meet clinical diagnostic criteria for psychosis
- Healthy (control) volunteers must not have any family history of mental illness
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxidative Cell Injury: First Episode Psychotic Patients
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.
Read the 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.
- Conditions
- Psychoses
- Keywords
- Complementary Therapies
- Medical subject headings
- Psychotic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startSep 1999
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Sahebrao P. Mahadik, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070889
- Sponsor's protocol ID
- R01AT000147-01
- Status last verified
- Jul 2006
- First submitted
- 9 Oct 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Cell Injury: First Episode Psychotic Patients
- ClinicalTrials.gov ID
- NCT00070889
- Acronym / sponsor ID
- R01AT000147-01
- Conditions
- Psychoses
- Keywords
- Complementary Therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Aug 2004
- First posted
- 13 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients must meet clinical diagnostic criteria for psychosis
- Healthy (control) volunteers must not have any family history of mental illness
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahebrao P. Mahadik, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychoses, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.