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The Effect of Plasma Osmolality on Brain Glutamate

The Role of Cortical Glutamate and GABA in Brains Osmotic Regulation: A Pilot Study in Healthy Volunteers and in Patients With Schizophrenia

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00611741
Acronym
MRS
Enrollment
30
Registered
2008-02-11
Start date
2007-03-31
Completion date
2012-03-31
Last updated
2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

MRS, glutamate, osmolality

Brief 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.

Interventions

DRUGfurosemide, Na supplements

furosemide 20 mg, Na supplements 8g in divided doses/day for 5 days

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

for healthy controls 1. Ages of 21-45 years from all ethnic backgrounds. 2. Male or female. 3. Written informed consent. 4. Female subjects will be studied during the follicular phase of their menstrual cycle.\*

Exclusion criteria

for healthy controls 1. DSM-IV diagnosis of psychotic, anxiety, mood disorder. 2. 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). 3. History of allergies to drugs such as sulfa, multiple adverse drug reactions or known allergy to furosemide. 4. 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. 5. History of major psychiatric disorder in first-degree relatives. 6. Current substance abuse/dependency determined by plasma and urine toxicology. 7. Current treatment with medications with psychotropic effects. 8. Current pregnancy, unsatisfactory birth control method report for females. 9. Education \< 12th grade. 10. Non-English speaking. Inclusion criteria for patients with schizophrenia 1. Ages of 21-45 years from all ethnic backgrounds. 2. Male or female. 3. Written informed consent. 4. DSM-IV diagnosis of schizophrenia or schizoaffective disorder. 5. 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. 6. 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. 7. Female subjects will be studied during the follicular phase of their menstrual cycle\*.

Design outcomes

Primary

MeasureTime frame
Cortical glutamate concentrationBaseline and endpoint

Secondary

MeasureTime frame
Cognitive functionBaseline and end point

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026