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CompletedNCT00611572Updated Jul 22, 2022

GABA-glutamate Interactions and Psychosis

A Phase 1 interventional study of iomazenil and iomazenil in Cognitive Dysfunction, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by Yale University · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cognitive Dysfunction

Keywords

  • GABA
  • glutamate
  • NMDA
  • P300
  • MMN
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 23 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    1

    Active iomazenil and ketamine

    Drug: iomazenil

  • Placebo comparator
    2

    placebo iomazenil and ketamine

    Drug: iomazenil

Interventions

  • Drugiomazenil

    Given as IV infusion

  • Drugiomazenil

    saline IV infusion

06

What researchers measure

Primary outcomes

  1. P300 as an ERP measure

    Time frame: prospective

Secondary outcomes

  1. MMN (Mismatch Negativity)

    Time frame: prospective

07

Study locations

1 site
  • VHA Connecticut
    West Haven, Connecticut 06516, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00611572
Lead sponsor
Yale University
Collaborators
National Alliance for Research on Schizophrenia and Depression
Responsible party
Sponsor
First posted
Feb 11, 2008
Start date
Jan 2007
Primary completion
Oct 2, 2018
Completion
Oct 2, 2018
Last update
Jul 22, 2022

Study contacts

Mohini Ranganathan, M.D.
principal investigator · Yale School of Medicine, Associate Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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