SchizophreniaNCT01399437
Brain Functions Underlying Visuospatial Attention Deficits in Schizophrenia
An observational study of Schizophrenia, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: A special brain circuit is important for helping us keeping an eye open for things that are going on around us, even when we are not directly paying attention to them. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2011to 24 Dec 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants:
- Age 18 through 55.
- Normal or corrected to normal visual acuity (at least 20/80)
- Participants with menat illness:
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Ability to give written informed consent
- Four week of stable pharmacological treatment (same psychiatric medication at same dose or no medication)
Who cannot join
- All participants:
- Presence of ferromagnetic metal objects in the body, implanted electronic devices or any other counter -indication for MRI.
- Claustrophobia
- Left handed or ambidextrous
- History of myocardial infarction or heart failur, which may cause asymptomatic brain lesions
- Uncontrolled high blood pressure (resting systolic greater than 150 or diastolic greater than 90 mm Hg)
Show all 13Show fewer
- Neurological conditions likely to impair cognitive function such as stroke, seizures, dementia or organic brian syndrome
- Any condition likely to impair cognitive function such as mental retardation or severe pharmacological sedation
- Current use of vasodilating beta-blockers (carvedilol, labetalol or nebivolol)
- Alcohol or substance abuse or dependence other than nicotine within the last 6 months
- Pregnancy, verified by urin pregnancy test for females during screening and on the day of the scan.
- Healthy Controls:
- Current psychiatric Axis I disorder or Axis II schizophrenia spectrum disorder, verified by Structured Clinical Interview for DSM-IV (SCID)
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
About this study
Official title: Default Network Dysfunction Underlying Visuospatial Attention Deficits in Schizophrenia
Background:
- A special brain circuit is important for helping us keeping an eye open for things that are going on around us, even when we are not directly paying attention to them. This circuit seems to work differently in people with schizophrenia than in other people, which may explain specific deficits with broad monitoring observed in people with schizophrenia. Researchers want to compare brain function in people with schizophrenia and healthy volunteers to find out more about how these brain circuits work and affect attention.
Read more
Objectives:
- To study how the brain performs broad visual monitoring in people with schizophrenia.
Eligibility:
- Individuals between 18 to 55 years of age who have been diagnosed with schizophrenia.
- Healthy volunteers between 18 and 55.
Design:
- Participants will be screened with physical and psychological exams. They will have a medical history. Tests for drug and alcohol use will also be done.
- Participants will have two study visits. The first is a training visit and the second is a scanning visit.
- At the training visit, participants will practice computer-based tests of focus, memory, and concentration. They will also answer questions about mood, psychiatric symptoms, and smoking habits.
- At the scanning visit, participants will perform the computer-based tasks that they practiced at the training visit. They will have magnetic resonance imaging while they perform these tasks.
Read the detailed description
Objective: To test a neural circuit explanation for a visuospatial attention abnormality seen in schizophrenia. Specifically, the aim is to test whether broad monitoring deficits may be based on a disruption of the so-called sentinel function of the default network. Because the default network is modulated by nicotinic compounds, such finding would implicate a possible remediation strategy.<TAB>
Study population: 24 people with schizophrenia, 24 matched healthy control subjects.
Design: A group comparison of attention task performance and associated brain activity as measured by functional Magnetic Resonance Imaging.
Outcome measures: Measures of attention task performance (reaction time, accuracy), BOLD signal within regions of the default network, degree of temporal association of BOLD signal with trial-by-trial reaction time.
- Conditions
- Schizophrenia
- Keywords
- Default Network, Schizophrenia, fMRI, Spatial Attention, Sentinel Function
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral performance measures on the cognitive tasks (e.g. reaction time, accuracy)
Bold signal, specifically activation of the default network of resting brain function and its association with task performance.
Secondary outcomes (1)
Secondary outcome measures include ratings and scores on questionnaires and characterization tools.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study start3 Jul 2011
- Study completion24 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399437
- Sponsor's protocol ID
- 999911470
- Other IDs
- 11-DA-N470
- Status last verified
- 24 Dec 2014
- First submitted
- 20 Jul 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Binder JR, Frost JA, Hammeke TA, Bellgowan PS, Rao SM, Cox RW. Conceptual processing during the conscious resting state. A functional MRI study. J Cogn Neurosci. 1999 Jan;11(1):80-95. doi: 10.1162/089892999563265.
PubMed 9950716Buckner RL, Andrews-Hanna JR, Schacter DL. The brain's default network: anatomy, function, and relevance to disease. Ann N Y Acad Sci. 2008 Mar;1124:1-38. doi: 10.1196/annals.1440.011.
PubMed 18400922Bustillo JR, Thaker G, Buchanan RW, Moran M, Kirkpatrick B, Carpenter WT Jr. Visual information-processing impairments in deficit and nondeficit schizophrenia. Am J Psychiatry. 1997 May;154(5):647-54. doi: 10.1176/ajp.154.5.647.
PubMed 9137120
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Default Network Dysfunction Underlying Visuospatial Attention Deficits in Schizophrenia
- ClinicalTrials.gov ID
- NCT01399437
- Acronym / sponsor ID
- 999911470
- Conditions
- Schizophrenia
- Keywords
- Default Network, Schizophrenia, fMRI, Spatial Attention, Sentinel Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 3 Jul 2011
- Study completion
- 24 Dec 2014
- First posted
- 21 Jul 2011 (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.
Background:
- A special brain circuit is important for helping us keeping an eye open for things that are going on around us, even when we are not directly paying attention to them. This circuit seems to work differently in people with schizophrenia than in other people, which may explain specific deficits with broad monitoring observed in people with schizophrenia. Researchers want to compare brain function in people with schizophrenia and healthy volunteers to find out more about how these brain circuits work and affect attention.
Objectives:
- To study how the brain performs broad visual monitoring in people with schizophrenia.
Eligibility:
- Individuals between 18 to 55 years of age who have been diagnosed with schizophrenia.
- Healthy volunteers between 18 and 55.
Design:
- Participants will be screened with physical and psychological exams. They will have a medical history. Tests for drug and alcohol use will also be done.
- Participants will have two study visits. The first is a training visit and the second is a scanning visit.
- At the training visit, participants will practice computer-based tests of focus, memory, and concentration. They will also answer questions about mood, psychiatric symptoms, and smoking habits.
- At the scanning visit, participants will perform the computer-based tasks that they practiced at the training visit. They will have magnetic resonance imaging while they perform these tasks.
Detailed description
Objective: To test a neural circuit explanation for a visuospatial attention abnormality seen in schizophrenia. Specifically, the aim is to test whether broad monitoring deficits may be based on a disruption of the so-called sentinel function of the default network. Because the default network is modulated by nicotinic compounds, such finding would implicate a possible remediation strategy.<TAB>
Study population: 24 people with schizophrenia, 24 matched healthy control subjects.
Design: A group comparison of attention task performance and associated brain activity as measured by functional Magnetic Resonance Imaging.
Outcome measures: Measures of attention task performance (reaction time, accuracy), BOLD signal within regions of the default network, degree of temporal association of BOLD signal with trial-by-trial reaction time.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 through 55.
- Normal or corrected to normal visual acuity (at least 20/80)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Ability to give written informed consent
- Four week of stable pharmacological treatment (same psychiatric medication at same dose or no medication)
Key exclusion criteria (13 listed)
- Presence of ferromagnetic metal objects in the body, implanted electronic devices or any other counter -indication for MRI.
- Claustrophobia
- Left handed or ambidextrous
- History of myocardial infarction or heart failur, which may cause asymptomatic brain lesions
- Uncontrolled high blood pressure (resting systolic greater than 150 or diastolic greater than 90 mm Hg)
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
Behavioral performance measures on the cognitive tasks (e.g. reaction time, accuracy)
Bold signal, specifically activation of the default network of resting brain function and its association with task performance.
1 secondary outcome
Secondary outcome measures include ratings and scores on questionnaires and characterization tools.
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 5 Apr 2018.
- Background: PubMed 9950716Binder JR, Frost JA, Hammeke TA, Bellgowan PS, Rao SM, Cox RW. Conceptual processing during the conscious resting state. A functional MRI study. J Cogn Neurosci. 1999 Jan;11(1):80-95. doi: 10.1162/089892999563265.
- Background: PubMed 18400922Buckner RL, Andrews-Hanna JR, Schacter DL. The brain's default network: anatomy, function, and relevance to disease. Ann N Y Acad Sci. 2008 Mar;1124:1-38. doi: 10.1196/annals.1440.011.
- Background: PubMed 9137120Bustillo JR, Thaker G, Buchanan RW, Moran M, Kirkpatrick B, Carpenter WT Jr. Visual information-processing impairments in deficit and nondeficit schizophrenia. Am J Psychiatry. 1997 May;154(5):647-54. doi: 10.1176/ajp.154.5.647.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Schizophrenia
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
RecruitingObservational study
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
Schizophrenia
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
Schizophrenia
Not yet recruitingPhase 1
Phase I Trial of HHK101 in Patients With Schizophrenia
Schizophrenia
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.
Elliot Stein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 National Institute on Drug Abuse (NIDA) 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 7 inclusion and 13 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 5 Apr 2018. 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?
Behavioral performance measures on the cognitive tasks (e.g. reaction time, accuracy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399437, which also lists 3 linked publications.
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 5 Apr 2018.