GABA-glutamate Interactions and Psychosis

This study is ongoing, but not recruiting participants.
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: February 8, 2016
Last verified: February 2016
  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

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

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 2017
Estimated Primary Completion Date: July 2017 (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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611572

Locations
United States, Connecticut
VHA Connecticut
West Haven, Connecticut, United States, 06516
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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00611572     History of Changes
Other Study ID Numbers: 0508000517 
Study First Received: January 29, 2008
Last Updated: February 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
GABA
glutamate
NMDA
P300
MMN

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2016