GABA-glutamate Interactions and Psychosis

Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00611572

Enrollment

Registered

2008-02-11

Start date

2007-01-31

Completion date

2018-10-02

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

Keywords

GABA, glutamate, NMDA, P300, MMN

Brief 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.

Interventions

DRUGiomazenil

Given as IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
P300 as an ERP measure	prospective

Secondary

Measure	Time frame
MMN (Mismatch Negativity)	prospective

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026