The Effect of Plasma Osmolality on Brain Glutamate

NCT ID: NCT00611741

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-03-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Drug intervention, longitudinal

Furosemide and Na supplements

Group Type: EXPERIMENTAL

furosemide, Na supplements

Intervention Type: DRUG

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

Interventions

furosemide, Na supplements

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.*

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

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.

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Handan Gunduz-Bruce

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Handan Gunduz-Bruce, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

34 Park Street, CMHC

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0612002149

Identifier Type: -

Identifier Source: org_study_id