GABA-glutamate Interactions and Psychosis

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00611572

Collaborator

National Alliance for Research on Schizophrenia and Depression (Other)

Enrollment

Location

Arms

141

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Dysfunction	Drug: iomazenil Drug: iomazenil	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Oct 2, 2018

Actual Study Completion Date :

Oct 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Active iomazenil and ketamine	Drug: iomazenil Given as IV infusion
Placebo Comparator: 2 placebo iomazenil and ketamine	Drug: iomazenil saline IV infusion

Arm

Intervention/Treatment

Active Comparator: 1

Active iomazenil and ketamine

Drug: iomazenil

Given as IV infusion

Placebo Comparator: 2

placebo iomazenil and ketamine

Drug: iomazenil

saline IV infusion

Outcome Measures

Primary Outcome Measures

P300 as an ERP measure [prospective]

Secondary Outcome Measures

MMN (Mismatch Negativity) [prospective]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.