SchizophreniaPhase 1MRSNCT00611741
The Effect of Plasma Osmolality on Brain Glutamate
A Phase 1 study testing furosemide, Na supplements in people with Schizophrenia, run by Yale University at 1 site in United States.
Trial summary
This study is designed to test the hypothesis that plasma osmolality is linked with cortical glutamate concentrations in the brain. It also investigates whether the glutamate response in schizophrenia is enhanced compared to healthy controls. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- furosemide, Na supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2012
- Phase
- Phase 1
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages of 21-45 years from all ethnic backgrounds.
- Male or female.
- Written informed consent.
- Female subjects will be studied during the follicular phase of their menstrual cycle.*
- Ages of 21-45 years from all ethnic backgrounds.
- Male or female.
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- Written informed consent.
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
- For treated patients: The patient has been on a stable dose of medications (antipsychotics, antidepressants) for the past month and does not require a change of medications or dose adjustment at study entry.
- For untreated patients: Has refused to be treated with medications, maintains regular clinic appointments with the clinicians, and does not pose an imminent danger to himself or others.
- Female subjects will be studied during the follicular phase of their menstrual cycle*.
Who cannot join
- DSM-IV diagnosis of psychotic, anxiety, mood disorder.
- A history of significant medical/neurological disease. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox, Urine pregnancy test, folic acid, B12 levels).
- History of allergies to drugs such as sulfa, multiple adverse drug reactions or known allergy to furosemide.
- Any medication that in the opinion of the PI could interfere with either the safety of the study and/or the outcome measures, such as over the counter cough suppressants or antihistamines.
- History of major psychiatric disorder in first-degree relatives.
- Current substance abuse/dependency determined by plasma and urine toxicology.
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- Current treatment with medications with psychotropic effects.
- Current pregnancy, unsatisfactory birth control method report for females.
- Education < 12th grade.
- Non-English speaking.
- A history of significant medical/neurological disease. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox, Urine pregnancy test, folic acid, B12 levels).
- Orthostatic systolic blood pressure change>20 mmHg or orthostatic pulse change>20 bpm.
- History of polydipsia/hyponatremia**.
- History of allergies to drugs such as sulfa, multiple adverse drug reactions or known allergy to furosemide.
- Any medication that in the opinion of the PI could interfere with either the safety of the study and/or the outcome measures, such as over the counter cough suppressants or antihistamines.
- Current use of lithium (lithium directly interferes with electrolyte balance).
- Currently on clozapine as clozapine may interfere with brain water regulation (Leadbetter and Shutty, 1994).
- Current substance abuse/dependency determined by plasma and urine toxicology.
- Current treatment with benzodiazepines or mood stabilizers (these medications can alter glutamate transmission).
- Current pregnancy, unsatisfactory birth control method report for females.
- IQ < 70 as determined by Wechsler Abbreviated Scale of Intelligence.
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Cortical Glutamate and GABA in Brains Osmotic Regulation: A Pilot Study in Healthy Volunteers and in Patients With Schizophrenia
This study is designed to test the hypothesis that plasma osmolality is linked with cortical glutamate concentrations in the brain. It also investigates whether the glutamate response in schizophrenia is enhanced compared to healthy controls.
- Conditions
- Schizophrenia
- Being tested
- furosemide, Na supplements
- Keywords
- MRS, glutamate, osmolality
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemide, Na supplementsDrug
furosemide 20 mg, Na supplements 8g in divided doses/day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Drug intervention, longitudinal | Experimental | Furosemide and Na supplements Receives: Drug: furosemide, Na supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical glutamate concentration
Measured: Baseline and endpoint
Secondary outcomes (1)
Cognitive function
Measured: Baseline and end point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2011
- Study completionMar 2012
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.
- More trials run by Yale UniversityThe 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Handan Gunduz-Bruce, Yale University
- Investigators
- Handan Gunduz-Bruce, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611741
- Sponsor's protocol ID
- 0612002149
- Acronym
- MRS
- Status last verified
- Aug 2012
- First submitted
- 29 Jan 2008
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cortical Glutamate and GABA in Brains Osmotic Regulation: A Pilot Study in Healthy Volunteers and in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00611741
- Acronym / sponsor ID
- MRS / 0612002149
- Conditions
- Schizophrenia
- Keywords
- MRS, glutamate, osmolality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Feb 2008 (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.
This study is designed to test the hypothesis that plasma osmolality is linked with cortical glutamate concentrations in the brain. It also investigates whether the glutamate response in schizophrenia is enhanced compared to healthy controls.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug intervention, longitudinal | Experimental | Drug: furosemide, Na supplementsFurosemide and Na supplements |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ages of 21-45 years from all ethnic backgrounds.
- Male or female.
- Written informed consent.
- Female subjects will be studied during the follicular phase of their menstrual cycle.*
- Ages of 21-45 years from all ethnic backgrounds.
Key exclusion criteria (22 listed)
- DSM-IV diagnosis of psychotic, anxiety, mood disorder.
- A history of significant medical/neurological disease. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox, Urine pregnancy test, folic acid, B12 levels).
- History of allergies to drugs such as sulfa, multiple adverse drug reactions or known allergy to furosemide.
- Any medication that in the opinion of the PI could interfere with either the safety of the study and/or the outcome measures, such as over the counter cough suppressants or antihistamines.
- History of major psychiatric disorder in first-degree relatives.
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 |
|---|---|---|
| furosemide, Na supplementsfurosemide 20 mg, Na supplements 8g in divided doses/day for 5 days | Drug | Drug intervention, longitudinal |
Primary outcome
Cortical glutamate concentration
Time frame: Baseline and endpoint
1 secondary outcome
Cognitive function
Time frame: Baseline and end point
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 9 Feb 2016.
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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.
Handan Gunduz-Bruce, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing furosemide, Na supplements in people with Schizophrenia, run by Yale 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 22 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 9 Feb 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cortical glutamate concentration (time frame: Baseline and endpoint). 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 9 Feb 2016.