Back to resultsGABA-glutamate Interactions and Psychosis
Primary Purpose
Cognitive Dysfunction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
iomazenil
iomazenil
Sponsored by
About this trial
This is an interventional other trial for Cognitive Dysfunction focused on measuring GABA, glutamate, NMDA, P300, MMN
Eligibility 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.
Sites / Locations
- VHA Connecticut
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Active iomazenil and ketamine
placebo iomazenil and ketamine
Outcomes
Primary Outcome Measures
P300 as an ERP measure
Secondary Outcome Measures
MMN (Mismatch Negativity)
Full Information
NCT ID
NCT00611572
First Posted
January 29, 2008
Last Updated
July 21, 2022
Sponsor
Yale University
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00611572
Brief Title
GABA-glutamate Interactions and Psychosis
Official Title
Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
GABA, glutamate, NMDA, P300, MMN
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Active iomazenil and ketamine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo iomazenil and ketamine
Intervention Type
Drug
Intervention Name(s)
iomazenil
Intervention Description
Given as IV infusion
Intervention Type
Drug
Intervention Name(s)
iomazenil
Intervention Description
saline IV infusion
Primary Outcome Measure Information:
Title
P300 as an ERP measure
Time Frame
prospective
Secondary Outcome Measure Information:
Title
MMN (Mismatch Negativity)
Time Frame
prospective
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohini Ranganathan, M.D.
Organizational Affiliation
Yale School of Medicine, Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
VHA Connecticut
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
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GABA-glutamate Interactions and Psychosis
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