GABA-glutamate Interactions and Psychosis

NCT00611572 | Completed Phase 1

• 1 other identifier: 0508000517
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Keywords

GABA; glutamate; NMDA; P300; MMN

Outcome Measures

Primary Outcomes (1)

• P300 as an ERP measure

  prospective

Secondary Outcomes (1)

• MMN (Mismatch Negativity)

  prospective

Study Arms (2)

1

ACTIVE COMPARATOR

Active iomazenil and ketamine

Drug: iomazenil

2

PLACEBO COMPARATOR

placebo iomazenil and ketamine

Drug: iomazenil

Interventions

iomazenil DRUG

Given as IV infusion

1

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages of 21-45 years from all ethnic backgrounds.
• Male or female.
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

VHA Connecticut

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

iomazenil

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mohini Ranganathan, M.D.

  Yale School of Medicine, Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: January 1, 2007
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

US (1)