GABA-glutamate Interactions and Psychosis
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
- Cognitive Dysfunction
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 21 Years to 45 Years |
| Enrollment: | 23 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Other |
MaskingTRIPLE:
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Clinical Trial Dates
| Start date: | Jan 01, 2007 | |
|---|---|---|
| Primary Completion: | Oct 02, 2018 | ACTUAL |
| Completion Date: | Oct 02, 2018 | ACTUAL |
| Study First Posted: | Feb 11, 2008 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jul 21, 2022 |
Sponsors / Collaborators
Location
Participant Groups
-
Active iomazenil and ketamine
-
placebo iomazenil and ketamine
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 21 |
| Maximum Age: | 45 |
| Age Groups: | Adult |
| 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.
* 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.
Primary Outcomes
-
P300 as an ERP measure prospective
Secondary Outcomes
-
MMN (Mismatch Negativity) prospective
More Details
| NCT Number: | NCT00611572 |
|---|---|
| Other IDs: | 0508000517 |
| Study URL: | https://clinicaltrials.gov/study/NCT00611572 |
Last updated: Sep 29, 2023