GABA-glutamate Interactions and Psychosis

NCT ID: NCT00611572

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2018-10-02

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Active iomazenil and ketamine

Group Type ACTIVE_COMPARATOR

iomazenil

Intervention Type DRUG

Given as IV infusion

2

placebo iomazenil and ketamine

Group Type PLACEBO_COMPARATOR

iomazenil

Intervention Type DRUG

saline IV infusion

Interventions

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iomazenil

Given as IV infusion

Intervention Type DRUG

iomazenil

saline IV infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohini Ranganathan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale School of Medicine, Associate Professor

Locations

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VHA Connecticut

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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0508000517

Identifier Type: -

Identifier Source: org_study_id

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