Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

GABA-glutamate Interactions and Psychosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00611572
First received: January 29, 2008
Last updated: February 8, 2016
Last verified: February 2016

January 29, 2008
February 8, 2016
January 2007
July 2017   (final data collection date for primary outcome measure)
P300 as an ERP measure [ Time Frame: prospective ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611572 on ClinicalTrials.gov Archive Site
MMN (Mismatch Negativity) [ Time Frame: prospective ] [ Designated as safety issue: No ]
MMN [ Time Frame: prospective ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
GABA-glutamate Interactions and Psychosis
Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Cognitive Dysfunction
  • Drug: iomazenil
    Given as IV infusion
  • Drug: iomazenil
    saline IV infusion
  • Active Comparator: 1
    Active iomazenil and ketamine
    Intervention: Drug: iomazenil
  • Placebo Comparator: 2
    placebo iomazenil and ketamine
    Intervention: Drug: iomazenil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
July 2017
July 2017   (final data collection date for primary outcome measure)

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.
Both
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611572
0508000517
No
Not Provided
Not Provided
Yale University
Yale University
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Handan Gunduz-Bruce, M.D. Yale School of Medicine, Assistant Professor
Yale University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP