SchizophreniaNCT00536783
Schizophrenia Sensory Gating Deficit With Quetiapine
An observational study of Schizophrenia, run by New Mexico VA Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is the use of magnetoencephalography or MEG (a machine that measures magnetic activity in your brain) and electroencephalography or EEG (a technique that measures electrical activity in your brain) to study how sounds are processed in individuals with schizophrenia after three months of… Read more about this study
- Who is it for?
- Ages 18 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Quetiapine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Mar 2006
- 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 18 to 18 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient Population
- Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
- No comorbid diagnosis of PTSD
- responders to quetiapine, determined by continuous treatment at the same dose of quetiapine and absence of psychiatric hospitalization for at least 3 months
- No history of drug dependency in their lifetime
- No history of alcohol or other substance abuse in the 6 months prior to entry into the study
Show all 20Show fewer
- No history of head injury with loss of consciousness for more than 5 minutes
- No history of seizure disorder
- No mood stabilizing agents
- Between 18-65 and
- Able to sign informed consent
- Normal Controls
- Matched in age and gender to patient population
- No history of psychiatric dysfunction or alcohol or other substance dependence in their lifetime as determine by the SCID
- No history of alcohol or other substance abuse in the previous 6 months
- No family history of psychotic disorder in first degree relatives as assessed by the FH-RDC diagnostic interview
- No history of head injury with loss of consciousness for more than 5 minutes
- No history of seizure disorder
- Between 18-65
- Able to sign informed consent
Who cannot join
- Subjects will be excluded from participating in this study if they:
- Require treatment with a mood stabilizer
- Have had an inpatient hospitalization in the past 3 months
- Have a history of a neurological disorder
- Have any other axis I diagnosis besides schizophrenia
Trial locations and contacts
1 site in 1 country.
United States1 site
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108
About this study
The purpose of this study is the use of magnetoencephalography or MEG (a machine that measures magnetic activity in your brain) and electroencephalography or EEG (a technique that measures electrical activity in your brain) to study how sounds are processed in individuals with schizophrenia after three months of taking the antipsychotic medication quetiapine.
Read the detailed description
.Problems with attention and perception are core features of schizophrenia and are hypothesized to result from defects in the filtering or gating of sensory input. Examination of this requires neuoimaging techniques with high temporal resolution. High-density EEG and MEG in combination with structural magnetic resonance imaging (sMRI) are used to map sensory gating. In a number of recent studies patient treated with novel antipsychotics have been shown to have P50 gating ratios resembling those of normal controls rather than that of schizophrenia subjects treatment with conventional antipsychotics. To date, there is no literature on the effects of quetiapine on sensory gating. Subjects who meet all inclusion criteria and have been on a stable dose of quetiapine for three months will receive a clinical interview, an MRI, MEG, and neuropsychological testing to determine if patients with schizophrenia who are treated with quetiapine will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating.
- Conditions
- Schizophrenia
- Being tested
- Quetiapine
- Keywords
- Psychiatry, Antipsychotic, Psychopharmacology, Clinical Trial, Open Label, Schizophrenia, Sensory Gating, Attention, Memory
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startApr 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Mexico VA Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- AstraZeneca
- Investigators
- Jose M Canive, MD, Principal investigator, New Mexico VA Heathcare System / BRINM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536783
- Sponsor's protocol ID
- 0072
- Other IDs
- . IRUSQUET0332
- Status last verified
- Sep 2007
- First submitted
- 27 Sep 2007
- Last updated
- 31 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia Sensory Gating Deficit With Quetiapine
- ClinicalTrials.gov ID
- NCT00536783
- Acronym / sponsor ID
- 0072
- Conditions
- Schizophrenia
- Keywords
- Psychiatry, Antipsychotic, Psychopharmacology, Clinical Trial, Open Label, Schizophrenia, Sensory Gating, Attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New Mexico VA Healthcare SystemUS federal agency
- Collaborators
- AstraZeneca
- Study start
- Apr 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 28 Sep 2007 (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.
The purpose of this study is the use of magnetoencephalography or MEG (a machine that measures magnetic activity in your brain) and electroencephalography or EEG (a technique that measures electrical activity in your brain) to study how sounds are processed in individuals with schizophrenia after three months of taking the antipsychotic medication quetiapine.
Detailed description
.Problems with attention and perception are core features of schizophrenia and are hypothesized to result from defects in the filtering or gating of sensory input. Examination of this requires neuoimaging techniques with high temporal resolution. High-density EEG and MEG in combination with structural magnetic resonance imaging (sMRI) are used to map sensory gating. In a number of recent studies patient treated with novel antipsychotics have been shown to have P50 gating ratios resembling those of normal controls rather than that of schizophrenia subjects treatment with conventional antipsychotics. To date, there is no literature on the effects of quetiapine on sensory gating. Subjects who meet all inclusion criteria and have been on a stable dose of quetiapine for three months will receive a clinical interview, an MRI, MEG, and neuropsychological testing to determine if patients with schizophrenia who are treated with quetiapine will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Patient Population
- Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
- No comorbid diagnosis of PTSD
- responders to quetiapine, determined by continuous treatment at the same dose of quetiapine and absence of psychiatric hospitalization for at least 3 months
- No history of drug dependency in their lifetime
Key exclusion criteria (5 listed)
- Require treatment with a mood stabilizer
- Have had an inpatient hospitalization in the past 3 months
- Have a history of a neurological disorder
- Have any other axis I diagnosis besides schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine | Drug | – |
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 31 Dec 2007.
- The website for the Biomedical Research Institute of New Mexico which helps administers the funds for this project.Link provided by the sponsor.
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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.
Jose M Canive, MD principal investigator
New Mexico VA Heathcare System / BRINM
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 Schizophrenia, run by New Mexico VA Healthcare System 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 20 inclusion and 5 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 31 Dec 2007. 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 31 Dec 2007.