SchizophreniaNCT00288340
Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging
A study testing functional magnetic resonance imaging in people with Schizophrenia and Schizoaffective Disorder, run by Vanderbilt University at 1 site in United States.
Trial summary
The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. The investigators will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Hallucinations
- What is being tested?
- functional magnetic resonance imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2006
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Investigators will study subjects who:
- Are between the ages of 18 and 65.
- Meet diagnostic criteria for any psychiatric disorder with auditory hallucinations (at least one every 20 minutes) including schizophrenia/schizoaffective disorder OR schizophrenia/schizoaffective disorder without auditory hallucinations.
- Have been treated with an antipsychotic drug for hallucinations at least three months or are unmedicated
- Are willing to change their current antipsychotic medication if indicated
- Are able to provide written consent
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- Normal controls must :
- Be between the ages of 18 and 65
- Not meet the diagnostic criteria for schizophrenia or schizoaffective disorder or other psychiatric disorder involving hallucinations
- Not currently be treated with an antipsychotic drug
- Be able to provide written consent
Who cannot join
- Subjects and normal controls will be excluded from participation if there is:
- Evidence of non-psychiatric, chronic central nervous system (CNS) disease (such as brain injury or neurological disease)
- Contraindication to MRI, including prior claustrophobic reaction and severe movement disorder
- A recent change in menstrual status other than recent changes in oral or implanted contraceptive use (for females)
- A positive pregnancy result (for females)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. The investigators will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment.
Read the detailed description
The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. We will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. We will focus on changes in brain structure and function associated with frequent auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with neuroleptic treatment. In order to address these aims, we will study four groups of subjects:
- patients who have frequent auditory hallucinations,
- patients who are beginning a regimen of anti-psychotic medication,
- patients who do not have frequent hallucinations and are not changing medication strategies, and
- age-matched normal controls. Each group will contain 15 subjects for a total of 60.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Hallucinations
- Being tested
- functional magnetic resonance imaging
- Keywords
- psychotic disorders, auditory hallucinations, brain structure, psychiatric disorder with auditory hallucinations (at least one every 20 minutes), schizophrenia/schizoaffective disorder without auditory hallucinations
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| 1,2 | Active comparator | Not described Receives: Device: functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize abnormalities in brain structure and function related to schizophrenia
Measured: two scans over a six month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionAug 2006
- Study completionAug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Adam Anderson, Ph.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288340
- Sponsor's protocol ID
- 050978
- Other IDs
- NARSAD
- Status last verified
- Apr 2017
- First submitted
- 6 Feb 2006
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00288340
- Acronym / sponsor ID
- 050978
- Conditions
- Schizophrenia, Schizoaffective Disorder, Hallucinations
- Keywords
- psychotic disorders, auditory hallucinations, brain structure, psychiatric disorder with auditory hallucinations (at least one every 20 minutes), schizophrenia/schizoaffective disorder without auditory hallucinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jan 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 7 Feb 2006 (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 goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. The investigators will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment.
Detailed description
The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. We will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. We will focus on changes in brain structure and function associated with frequent auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with neuroleptic treatment. In order to address these aims, we will study four groups of subjects:
- patients who have frequent auditory hallucinations,
- patients who are beginning a regimen of anti-psychotic medication,
- patients who do not have frequent hallucinations and are not changing medication strategies, and
- age-matched normal controls. Each group will contain 15 subjects for a total of 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1,2 | Active comparator | Device: functional magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Are between the ages of 18 and 65.
- Meet diagnostic criteria for any psychiatric disorder with auditory hallucinations (at least one every 20 minutes) including schizophrenia/schizoaffective disorder OR schizophrenia/schizoaffective disorder without auditory hallucinations.
- Have been treated with an antipsychotic drug for hallucinations at least three months or are unmedicated
- Are willing to change their current antipsychotic medication if indicated
- Are able to provide written consent
Key exclusion criteria (5 listed)
- Evidence of non-psychiatric, chronic central nervous system (CNS) disease (such as brain injury or neurological disease)
- Contraindication to MRI, including prior claustrophobic reaction and severe movement disorder
- A recent change in menstrual status other than recent changes in oral or implanted contraceptive use (for females)
- A positive pregnancy result (for females)
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 |
|---|---|---|
| functional magnetic resonance imaging | Device | 1,2 |
Primary outcome
characterize abnormalities in brain structure and function related to schizophrenia
Time frame: two scans over a six month period
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 19 Apr 2017.
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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.
Adam Anderson, Ph.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional magnetic resonance imaging in people with Schizophrenia and Schizoaffective Disorder, run by Vanderbilt University 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 11 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 19 Apr 2017. 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.
What does the primary outcome measure?
characterize abnormalities in brain structure and function related to schizophrenia (time frame: two scans over a six month period). It is what the study was designed to measure, not a finding.
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 19 Apr 2017.