Overview

This trial is active, not recruiting.

Condition cognitive dysfunction
Treatments iomazenil
Phase phase 1
Sponsor Yale University
Collaborator National Alliance for Research on Schizophrenia and Depression
Start date January 2007
End date July 2017
Trial size 15 participants
Trial identifier NCT00611572, 0508000517

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, investigator, outcomes assessor)
Arm
(Active Comparator)
Active iomazenil and ketamine
iomazenil
Given as IV infusion
(Placebo Comparator)
placebo iomazenil and ketamine
iomazenil
saline IV infusion

Primary Outcomes

Measure
P300 as an ERP measure
time frame: prospective

Secondary Outcomes

Measure
MMN (Mismatch Negativity)
time frame: prospective

Eligibility Criteria

Male or female participants from 21 years up to 45 years old.

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.

Additional Information

Official title Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction
Principal investigator Handan Gunduz-Bruce, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Yale University.