GABA-Glutamate Interactions and Psychosis

This study is currently recruiting participants.

Verified by Yale University, January 2008

Sponsors and Collaborators:	Yale University National Alliance for Research on Schizophrenia and Depression
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00611572

Purpose

This study investigates the interactions between NMDA antagonism and GABA system as it relates to cognitive function assessed by ERPs in healthy volunteers.

Condition	Intervention	Phase
Cognitive Dysfunction	Drug: iomazenil	Phase I Phase II

Drug Information available for: Sodium chloride Glutamic acid Iomazenil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Official Title:	Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction

Further study details as provided by Yale University:

Primary Outcome Measures:

P300 as an ERP measure [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MMN [ Time Frame: prospective ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Active iomazenil and ketamine	Drug: iomazenil Given as IV infusion
2: Placebo Comparator placebo iomazenil and ketamine	Drug: iomazenil saline IV infusion

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611572

Contacts

Contact: Sara Thaxton, BS

203 932 5711 ext 5326

sara.thaxton@yale.edu

Locations

United States, Connecticut
VHA Connecticut	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Sara Thaxton, BS 203-932-5711 ext 5326 sara.thaxton@yale.edu
Sub-Investigator: John H Krystal, M.D.

Sponsors and Collaborators

Yale University

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Handan Gunduz-Bruce, M.D.

Yale School of Medicine, Assistant Professor

More Information

Responsible Party:	Assistant Professor of Psychiatry ( Handan Gunduz-Bruce, M.D. Psychiatrist )
Study ID Numbers:	0508000517
Study First Received:	January 29, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00611572
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yale University:

GABA, glutamate, NMDA, P300, MMN

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Psychotic Disorders

Dementia
Cognition Disorders
Delirium

ClinicalTrials.gov processed this record on January 15, 2009