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GABA-glutamate Interactions and Psychosis

Yale University logo

Yale University

Status and phase

Completed
Phase 1

Conditions

Cognitive Dysfunction

Treatments

Drug: iomazenil

Study type

Interventional

Funder types

Other

Identifiers

NCT00611572
0508000517

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

23 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Active iomazenil and ketamine
Treatment:
Drug: iomazenil
Drug: iomazenil
2
Placebo Comparator group
Description:
placebo iomazenil and ketamine
Treatment:
Drug: iomazenil
Drug: iomazenil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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