NCT02626832

Brief Summary

This study aims to develop a method for the assessment of central NMDA receptor functioning in patients with depression and schizophrenia. For this purpose a transitional approach is used based on preclinical studies that show a dose-dependent relationship between the activity of hypothalamic NMDA receptor and plasma AVP response to increasing plasma osmolality. Patients with schizophrenia, depression and healthy controls participated in this study. The Investigators found that in a subgroup of patients with schizophrenia the AVP response was low and that in a subgroup of subjects with depression the AVP response was high compared to healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

3.8 years

First QC Date

November 4, 2015

Last Update Submit

December 8, 2015

Conditions

SchizophreniaDepression

Keywords

vasopressinAVPNMDAosmolality

Outcome Measures

Primary Outcomes (1)

  • AVP response to plasma osmolality as measured by slopes between the two variables

    Within 3 months

Study Arms (4)

Healthy Control

EXPERIMENTAL

This group is represented by healthy controls

Other: Procedural

Depression

EXPERIMENTAL

This experimental group is represented by subjects with depression

Other: Procedural

Schizophrenia

EXPERIMENTAL

This experimental group is represented by subjects with schizophrenia

Other: Procedural

Prodromal subjects

EXPERIMENTAL

This experimental group is represented by subjects with prodromal symptoms for schizophrenia

Other: Procedural

Interventions

ProceduralOTHER

All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations

DepressionHealthy ControlProdromal subjectsSchizophrenia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages of 18-55 years from all ethnic backgrounds.
  • Male or female.
  • Smoker or nonsmoker.
  • Written informed consent.

You may not qualify if:

  • DSM-IV diagnosis of psychotic, anxiety, mood disorder.
  • 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.
  • +56 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The John Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

SchizophreniaDepressionDiabetes Insipidus

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehaviorKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Handan Gunduz-Bruce, MD, MBA

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

December 10, 2015

Study Start

February 1, 2010

Primary Completion

November 1, 2013

Study Completion

December 1, 2014

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

US(2)