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GABA-glutamate Interactions and Psychosis

This study is currently recruiting participants.
Verified May 2012 by Yale University
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00611572
First received: January 29, 2008
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by ERPs (event-related potentials) in healthy volunteers.


Condition Intervention Phase
Cognitive Dysfunction
 Drug: iomazenil
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • P300 as an ERP measure [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MMN (Mismatch Negativity) [ Time Frame: prospective ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Active iomazenil and ketamine
 Drug: iomazenil
Given as IV infusion
Placebo Comparator: 2
placebo iomazenil and ketamine
 Drug: iomazenil
saline IV infusion

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Ages of 21-45 years from all ethnic backgrounds.
  • Male or female.
  • Written informed consent.

Exclusion criteria:

  • DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
  • A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox).
  • History of abnormal EEG.
  • History of severe allergies or multiple adverse drug reactions.
  • Any medication that could interfere with either the safety of the study and/or the outcome measures.
  • Any other conditions which in the opinion of the investigator would preclude participation in the study.
  • History of major psychiatric disorder in first degree relatives.
  • Current substance abuse/dependency determined by urine toxicology.
  • Treatment with medications with CNS effects.
  • Treatment with benzodiazepines within one week prior to testing.
  • Current treatment with medications with psychotropic effects.
  • Education < 10th grade.
  • IQ < 70, MR.
  • Non-English speaking.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611572

Contacts
Contact: Suravi Sircar, BS 203 932 5711 ext 5326 suravi.sircar@yale.edu

Locations
United States, Connecticut
VHA Connecticut Recruiting
West Haven, Connecticut, United States, 06516
Contact: Suravi Sircar, BS     203-932-5711 ext 5326     suravi.sircar@yale.edu    
Sub-Investigator: John H Krystal, M.D.            
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Handan Gunduz-Bruce, M.D. Yale School of Medicine, Assistant Professor
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00611572     History of Changes
Other Study ID Numbers: 0508000517
Study First Received: January 29, 2008
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
GABA
glutamate
NMDA
P300
MMN

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013