SchizophreniaNCT00567099
Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole
A study testing Aripiprzole in people with Schizophrenia and Sensory Gating, 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 prior to initiation with… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Sensory Gating
- What is being tested?
- Aripiprzole
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Sep 2008
- 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
- Patient Population
- Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
- no comorbid diagnosis of PTSD
- continuous treatment with a conventional antipsychotic, risperidone or olanzapine for at least 3 months
- absence of psychiatric hospitalization for at least 3 month
- no history of drug dependency in their lifetime
Show all 21Show fewer
- no history of alcohol or other substance abuse in the 6 months prior to entry into the study
- 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, 1 recruiting
- Recruiting
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108
Billy Jimenez, 505-265-1711 ext. 5117, billy.jimenez@va.gov
Robin R. Douglas, MA, CCRC, (505) 265-1711 ext. 5528, robin.douglas@med.va.gov
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 prior to initiation with aripiprazole treatment and after three months of taking the antipsychotic medication aripiprazole.
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 neuroimaging 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 aripiprzole on sensory gating. Subjects who meet all inclusion criteria will receive a clinical interview, an MRI, MEG, and neuropsychological testing before starting treatment with aripiprazole and again 3 months later to determine if patients with schizophrenia who are treated with aripiprazole will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating
- Conditions
- Schizophrenia, Sensory Gating
- Being tested
- Aripiprzole
- 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.
AripiprzoleDrug
Also called Aripiprazole (Abilify)
Dosage form, dosage, frequency and duration:
Aripiprazole 5-30 mg tabs po qday x 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
MEG/EEG and MRI data will be compared with the results of a neuropsych battery and symptom rating scales prior to initiation with aripiprazole and after subject has been on a stable dose of aripiprazole for three month.
Measured: MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startAug 2003
- Study completionSep 2008 (estimated)
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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Mexico VA Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Jose M Canive, MD, Principal investigator, New Mexico VA Healthcare System / BRINM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567099
- Sponsor's protocol ID
- 0059
- Other IDs
- BRINM #150
- Status last verified
- Dec 2007
- First submitted
- 3 Dec 2007
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole
- ClinicalTrials.gov ID
- NCT00567099
- Acronym / sponsor ID
- 0059
- Conditions
- Schizophrenia, Sensory Gating
- Keywords
- Psychiatry, Antipsychotic, Psychopharmacology, Clinical Trial, Open Label, Schizophrenia, Sensory Gating, Attention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New Mexico VA Healthcare SystemUS federal agency
- Collaborators
- Bristol-Myers Squibb
- Study start
- Aug 2003
- Study completion
- Sep 2008 (estimated)
- First posted
- 4 Dec 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 prior to initiation with aripiprazole treatment and after three months of taking the antipsychotic medication aripiprazole.
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 neuroimaging 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 aripiprzole on sensory gating. Subjects who meet all inclusion criteria will receive a clinical interview, an MRI, MEG, and neuropsychological testing before starting treatment with aripiprazole and again 3 months later to determine if patients with schizophrenia who are treated with aripiprazole will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patient Population
- Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
- no comorbid diagnosis of PTSD
- continuous treatment with a conventional antipsychotic, risperidone or olanzapine for at least 3 months
- absence of psychiatric hospitalization for at least 3 month
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 |
|---|---|---|
| AripiprzoleAlso: Aripiprazole (Abilify)Dosage form, dosage, frequency and duration: Aripiprazole 5-30 mg tabs po qday x 3 months | Drug | – |
Primary outcome
MEG/EEG and MRI data will be compared with the results of a neuropsych battery and symptom rating scales prior to initiation with aripiprazole and after subject has been on a stable dose of aripiprazole for three month.
Time frame: MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
- The website for the Biomedical Research Institute of New Mexico which helps administers the funds for this projectLink 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 Healthcare System / BRINM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aripiprzole in people with Schizophrenia and Sensory Gating, 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 21 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: status not confirmed, as of the sponsor's last update on 25 May 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Billy Jimenez ((505) 265-1711 ext. 5117, billy.jiminez@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEG/EEG and MRI data will be compared with the results of a neuropsych battery and symptom rating scales prior to initiation with aripiprazole and after subject has been on a stable dose of aripiprazole for three month. (time frame: MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole). 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 25 May 2010.