Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2010-02-28
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy Control
This group is represented by healthy controls
Procedural
All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations
Depression
This experimental group is represented by subjects with depression
Procedural
All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations
Schizophrenia
This experimental group is represented by subjects with schizophrenia
Procedural
All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations
Prodromal subjects
This experimental group is represented by subjects with prodromal symptoms for schizophrenia
Procedural
All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations
Interventions
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Procedural
All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations
Eligibility Criteria
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Inclusion Criteria
* Male or female.
* Smoker or nonsmoker.
* Written informed consent.
* Ages of 21-55 years from all ethnic backgrounds.
* Male or female.
* Smoker or nonsmoker.
* Written informed consent.
* DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
* For treated patients: The patient has been on a stable dose of antipsychotics 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.
* Ages of 21-55 years from all ethnic backgrounds.
* Male or female.
* Smoker or nonsmoker.
* Written informed consent.
* DSM-IV diagnosis of major depressive disorder, unipolar.
* For treated patients: The patient has been on a stable dose of medications (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.
* Ages of 18-40 years from all ethnic backgrounds.
* Male or female.
* Smoker or nonsmoker.
* Written informed consent.
Exclusion Criteria
* History of major psychiatric disorder in first-degree relatives.
* 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, uric acid, creatinine clearance, LFTs, TFTs, UA, Utox, Urine pregnancy test).
* A history of cardiac disease including arrhythmias; history of syncope or unexplained loss of consciousness; history of renal stones or renal failure; history of diabetes mellitus or diabetes insipidus.
* Subjects with hypertension (BP \> 140/90).
* Current hyponatremia.
* Serum Ca2+ and uric acid levels that are above normal range.
* Serum creatinine outside of normal range for age.
* Creatinine clearance \<70 ml/min using the Cockcroft-Gault equation (Cockcroft et al 1976) \[(140-age)\*(weight in kg)\*(.85 if female)/(72\*Cr)\].
* 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 diuretics of any type, lithium, carbamazepine.
* Current substance abuse/dependency determined by urine toxicology.
* Current treatment with medications with psychotropic effects.
* Current pregnancy, unsatisfactory birth control method report for females.
* IQ \< 70 as determined by Wechsler Abbreviated Scale of Intelligence.
* Non-English speaking.
* 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, uric acid, creatinine clearance, LFTs, TFTs, UA, Utox, Urine pregnancy test).
* A history of cardiac disease including arrhythmias; history of syncope or unexplained loss of consciousness; history of renal stones or renal failure; history of diabetes mellitus or diabetes insipidus.
* Serum Ca2+ and uric acid levels that are above normal range.
* Serum creatinine outside of normal range for age.
* Creatinine clearance \<70 ml/min using the Cockcroft-Gault equation \[(140-age)\*(weight in kg)\*(.85 if female)/(72\*Cr)\].
* Subjects with hypertension (BP \> 140/90).
* Current hyponatremia.
* 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 diuretics of any type, lithium, carbamazepine.
* Currently on clozapine as clozapine may interfere with brain water regulation (Leadbetter and Shutty, 1994).
* Current substance abuse/dependency determined by urine toxicology.
* Current pregnancy, unsatisfactory birth control method report for females.
* IQ \< 70 as determined by Wechsler Abbreviated Scale of Intelligence.
* Non-English speaking.
* 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, uric acid, creatinine clearance, LFTs, TFTs, UA, Utox, Urine pregnancy test).
* A history of cardiac disease including arrhythmias; history of syncope or unexplained loss of consciousness; history of renal stones or renal failure; history of diabetes mellitus or diabetes insipidus.
* Serum Ca2+ and uric acid levels that are above normal range.
* Serum creatinine outside of normal range for age.
* Creatinine clearance \<70 ml/min using the Cockcroft-Gault equation \[(140-age)\*(weight in kg)\*(.85 if female)/(72\*Cr)\].
* Subjects with hypertension (BP \> 140/90).
* Current hyponatremia.
* 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 diuretics of any type, lithium, carbamazepine.
* Current substance abuse/dependency determined by urine toxicology.
* Current pregnancy, unsatisfactory birth control method report for females.
* IQ \< 70 as determined by Wechsler Abbreviated Scale of Intelligence.
* Non-English speaking.
* 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, uric acid, creatinine clearance, LFTs, TFTs, UA, Utox, Urine pregnancy test).
* A history of cardiac disease including arrhythmias; history of syncope or unexplained loss of consciousness; history of renal stones or renal failure; history of diabetes mellitus or diabetes insipidus.
* Serum Ca2+ and uric acid levels that are above normal range.
* Serum creatinine outside of normal range for age.
* Creatinine clearance \<70 ml/min using the Cockcroft-Gault equation \[(140-age)\*(weight in kg)\*(.85 if female)/(72\*Cr)\].
* Subjects with hypertension (BP \> 140/90).
* Current hyponatremia.
* 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 diuretics of any type, lithium, carbamazepine.
* Currently on clozapine as clozapine may interfere with brain water regulation (Leadbetter and Shutty, 1994).
* Current substance abuse/dependency determined by urine toxicology.
* Current pregnancy, unsatisfactory birth control method report for females.
* IQ \< 70 as determined by Wechsler Abbreviated Scale of Intelligence.
* Non-English speaking.
18 Years
55 Years
ALL
Yes
Sponsors
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VA Connecticut Healthcare System
FED
The John B. Pierce Laboratory
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Handan Gunduz-Bruce, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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The John Pierce Laboratory
New Haven, Connecticut, United States
VA Connecticut Healthcare System
West Haven, Connecticut, United States
Countries
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Other Identifiers
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0910005875
Identifier Type: -
Identifier Source: org_study_id