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Completed

NCT Number: NCT00611741

The Effect of Plasma Osmolality on Brain Glutamate

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.

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

34 Park Street, CMHC

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for healthy controls

  • 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.*

Exclusion criteria

for healthy controls

  • 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.
  • Current treatment with medications with psychotropic effects.
  • Current pregnancy, unsatisfactory birth control method report for females.
  • Education < 12th grade.
  • Non-English speaking.

Inclusion criteria

for patients with schizophrenia

  • Ages of 21-45 years from all ethnic backgrounds.
  • Male or female.
  • 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*.

Exclusion criteria

for patients with schizophrenia

  • 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

Treatment and study plan

furosemide, Na supplements

Drug

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

Primary outcomes

  1. Cortical glutamate concentration

    Time frame: Baseline and endpoint

Secondary outcomes

  1. Cognitive function

    Time frame: Baseline and end point

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: MRS

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Feb 11, 2008
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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