SchizophreniaNCT01191827
fMRI Cholinergic Mechanisms in Schizophrenia
An observational study of Schizophrenia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2011
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects with schizophrenia
Who may be able to join
- Diagnosis of schizophrenia
- age 18-60 yrs
Who cannot join
- claustrophobia
- weight > 250 lbs
- metal in body other than dental fillings
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
About this study
This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.
Read the detailed description
This study will use functional magnetic resonance imaging (fMRI) to study patients treated with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those treated with clozapine to determine which brain areas are involved in clozapine's normalization of sensory gating in schizophrenia.
- Conditions
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| risperidone | Not described | |
| clozapine | Patients with schizophrenia treated with clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal Response During Sensory Gating
Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
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.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jason R. Tregellas, PhD, Principal investigator, VA Eastern Colorado Health Care System, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191827
- Sponsor's protocol ID
- MHBB-011-07F
- Status last verified
- May 2015
- First submitted
- 27 Aug 2010
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Cholinergic Mechanisms in Schizophrenia
- ClinicalTrials.gov ID
- NCT01191827
- Acronym / sponsor ID
- MHBB-011-07F
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.
Detailed description
This study will use functional magnetic resonance imaging (fMRI) to study patients treated with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those treated with clozapine to determine which brain areas are involved in clozapine's normalization of sensory gating in schizophrenia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| risperidone | – | – |
| clozapine | – | –Patients with schizophrenia treated with clozapine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects with schizophrenia
Key inclusion criteria (2 listed)
- Diagnosis of schizophrenia
- age 18-60 yrs
Key exclusion criteria (3 listed)
- claustrophobia
- weight > 250 lbs
- metal in body other than dental fillings
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
Neuronal Response During Sensory Gating
Time frame: Immediate
Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- 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.
Jason R. Tregellas, PhD principal investigator
VA Eastern Colorado Health Care System, Denver
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 US Department of Veterans Affairs 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 3 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 15 May 2015. 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 15 May 2015). 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?
Neuronal Response During Sensory Gating (time frame: Immediate). 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 15 May 2015.