The Effect of Plasma Osmolality on Brain Glutamate

NCT00611741 | Completed Phase 1 DMC

• 1 other identifier: 0612002149
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

MRS, glutamate, osmolality

Outcome Measures

Primary Outcomes (1)

• Cortical glutamate concentration

  Baseline and endpoint

Secondary Outcomes (1)

• Cognitive function

  Baseline and end point

Study Arms (1)

Drug intervention, longitudinal

EXPERIMENTAL

Furosemide and Na supplements

Drug: furosemide, Na supplements

Interventions

furosemide, Na supplements DRUG

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

Drug intervention, longitudinal

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.\*

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

34 Park Street, CMHC

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Handan Gunduz-Bruce, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: March 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: February 9, 2016

Record last verified: 2012-08

Locations

US (1)