Skip to main content
OpenTrials
Completed

NCT Number: NCT00611572

GABA-glutamate Interactions and Psychosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VHA Connecticut

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iomazenil

Drug

Given as IV infusion

Primary outcomes

  1. P300 as an ERP measure

    Time frame: prospective

Secondary outcomes

  1. MMN (Mismatch Negativity)

    Time frame: prospective

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study title

Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2008
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.