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The Effect of Plasma Osmolality on Brain Glutamate (MRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00611741
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: furosemide, Na supplements Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Role of Cortical Glutamate and GABA in Brains Osmotic Regulation: A Pilot Study in Healthy Volunteers and in Patients With Schizophrenia
Study Start Date : March 2007
Primary Completion Date : March 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Drug intervention, longitudinal
Furosemide and Na supplements
Drug: furosemide, Na supplements
furosemide 20 mg, Na supplements 8g in divided doses/day for 5 days


Outcome Measures

Primary Outcome Measures :
  1. Cortical glutamate concentration [ Time Frame: Baseline and endpoint ]

Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: Baseline and end point ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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*.

Exclusion criteria for patients with schizophrenia

  1. 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).
  2. Orthostatic systolic blood pressure change>20 mmHg or orthostatic pulse change>20 bpm.
  3. History of polydipsia/hyponatremia**.
  4. History of allergies to drugs such as sulfa, multiple adverse drug reactions or known allergy to furosemide.
  5. 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.
  6. Current use of lithium (lithium directly interferes with electrolyte balance).
  7. Currently on clozapine as clozapine may interfere with brain water regulation (Leadbetter and Shutty, 1994).
  8. Current substance abuse/dependency determined by plasma and urine toxicology.
  9. Current treatment with benzodiazepines or mood stabilizers (these medications can alter glutamate transmission).
  10. Current pregnancy, unsatisfactory birth control method report for females.
  11. IQ < 70 as determined by Wechsler Abbreviated Scale of Intelligence.
  12. Non-English speaking
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611741


Locations
United States, Connecticut
34 Park Street, CMHC
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Handan Gunduz-Bruce, M.D. Yale School of Medicine
More Information

Responsible Party: Handan Gunduz-Bruce, Assistant Clinical Professor, Yale University
ClinicalTrials.gov Identifier: NCT00611741     History of Changes
Other Study ID Numbers: 0612002149
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: August 2012

Keywords provided by Handan Gunduz-Bruce, Yale University:
MRS, glutamate, osmolality

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action