SchizophreniaNCT00931996
Oculomotor and Spatial Cognition Deficits in Schizophrenia
A study testing Antipsychotic in people with Schizophrenia, run by University of Illinois Chicago at 1 site in United States.
Trial summary
DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. Read more about this study
- Who is it for?
- Ages 15 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Antipsychotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Inclusion Criteria: Inclusion criteria for this study are (1) able and willing to give written informed consent; (2) no contraindications to MRI (cardiac pacemaker, aneurysm clip, cochlear implants, IUD, shrapnel, history of metal fragments in eyes, neurostimulators or other metal devices, weight of 250lbs or more, claustrophobia) and (3) medically stable. Sedation will not be used for MRI studies because cooperation is essential.
Who cannot join
- Any subject is excluded from the imaging studies if they have any contraindications to MRI such as cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy in the later stages (because of body size and limited comfort for MRI studies), IUD, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia. Individuals with mental retardation, neurologic disease or significant medical illness that might effect neuronal or vascular physiology will not be recruited.
Trial locations and contacts
1 site in 1 country.
United States1 site
UIC Center for Cognitive Medicine
Chicago, Illinois, 60612
About this study
Official title: Clinical and Computational Studies of Dopamine Function in Schizophrenia
DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. This application proposes a series of integrated behavioral studies designed to identify causes of deficits in schizophrenia.
Read the detailed description
We will be assessing clinical symptoms and cognition before and after treatment.
- Conditions
- Schizophrenia
- Being tested
- Antipsychotic
- Keywords
- schizophrenia, antipsychotic, risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntipsychoticDrug
Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Antipsychotic | Experimental | Antipsychotic Receives: Drug: Antipsychotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.
Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Study was terminated due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jeffrey R. Bishop, University of Illinois Chicago
- Investigators
- John A Sweeney, PhD, Principal investigator, UIC/UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931996
- Sponsor's protocol ID
- 2001-0522
- Other IDs
- R01MH062134, R01MH080066
- Status last verified
- Jan 2013
- First submitted
- 25 Jun 2009
- Last updated
- 24 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Computational Studies of Dopamine Function in Schizophrenia
- ClinicalTrials.gov ID
- NCT00931996
- Acronym / sponsor ID
- 2001-0522
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, antipsychotic, risperidone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to low accrual.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 24 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. This application proposes a series of integrated behavioral studies designed to identify causes of deficits in schizophrenia.
Detailed description
We will be assessing clinical symptoms and cognition before and after treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic | Experimental | Drug: AntipsychoticAntipsychotic |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Inclusion Criteria: Inclusion criteria for this study are (1) able and willing to give written informed consent; (2) no contraindications to MRI (cardiac pacemaker, aneurysm clip, cochlear implants, IUD, shrapnel, history of metal fragments in eyes, neurostimulators or other metal devices, weight of 250lbs or more, claustrophobia) and (3) medically stable. Sedation will not be used for MRI studies because cooperation is essential.
Key exclusion criteria (1 listed)
- Any subject is excluded from the imaging studies if they have any contraindications to MRI such as cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy in the later stages (because of body size and limited comfort for MRI studies), IUD, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia. Individuals with mental retardation, neurologic disease or significant medical illness that might effect neuronal or vascular physiology will not be recruited.
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 |
|---|---|---|
| AntipsychoticRisperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks. | Drug | Antipsychotic |
Primary outcome
Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.
Time frame: Baseline and 6 weeks
Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John A Sweeney, PhD principal investigator
UIC/UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antipsychotic in people with Schizophrenia, run by University of Illinois Chicago 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Jan 2013. 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?
Yes. Results are posted in the registry (first posted 24 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline. (time frame: Baseline and 6 weeks). 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 24 Jan 2013.