N-acetylcysteine and NMDA Antagonist Interactions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00611897
First received: January 29, 2008
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

This study tests the hypothesis that extrasynaptic mechanisms are critically linked with cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in healthy humans.


Condition Intervention Phase
Cognitive Dysfunction
Drug: N-acetylcysteine and ketamine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: N-acetylcysteine and NMDA Antagonist Interactions

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • P300 as detected by ERP [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mismatch Negativity (MMN) [ Time Frame: prospective ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I Drug: N-acetylcysteine and ketamine
Active drug (N-acetylcysteine)
Placebo Comparator: Arm II
placebo drug (placebo N-acetylcysteine)
Drug: N-acetylcysteine and ketamine
placebo N-acetylcysteine

  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, Urine pregnancy test) .
  • History of severe allergies or multiple adverse drug reactions.
  • Any medication that in the opinion of the PI 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.
  • Current treatment with medications with psychotropic effects.
  • Treatment with benzodiazepines within one week prior to testing.
  • Current pregnancy, unsatisfactory birth control method report for females.
  • Education < 10th grade.
  • IQ < 70, MR as determined by Wechsler Abbreviated Scale of Intelligence.
  • Non-English speaking.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611897

Locations
United States, Connecticut
VHA Connecticut
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Handan Gunduz-Bruce, M.D. Yale School of Medicine
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00611897     History of Changes
Other Study ID Numbers: 0508000518
Study First Received: January 29, 2008
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
NMDA
glutamate
N-acetylcysteine
P3

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Ketamine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014