GABA-glutamate Interactions and Psychosis

Cognitive Dysfunction Clinical Trial

Official title:

Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611572
• Other study ID #: 0508000517
• Status: Completed
• Phase: Phase 1
• Start date: January 2007
• Est. completion date: October 2, 2018

Study information

• Verified date: July 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

Drug:
• iomazenil
Given as IV infusion
• iomazenil
saline IV infusion

Locations

Country	Name	City	State
United States	VHA Connecticut	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P300 as an ERP measure		prospective
Secondary	MMN (Mismatch Negativity)		prospective