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OpenTrials
Completed

NCT Number: NCT00611897

N-acetylcysteine and NMDA Antagonist Interactions

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.

Completed

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Key information

Conditions

Cognitive Dysfunction Cognition Disorders Mental Disorders Neurocognitive Disorders

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

VHA Connecticut

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine and ketamine

Drug

Active drug (N-acetylcysteine)

Other names: NAC

Placebo and Ketamine

Drug

placebo N-acetylcysteine

Primary outcomes

  1. Target P300

    Time frame: daily

    The Target P300 measures were obtained from the Fz, Cz and Pz electrodes.

    Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL.

  2. Novel P300

    Time frame: daily

    The Novel P300 measures were obtained from the Fz, Cz and Pz electrodes.

    Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL.

Secondary outcomes

  1. Mismatch Negativity (MMN) Intensity

    Time frame: daily

    Mismatch Negativity (MMN) Intensity difference waves at midline electrodes (Fz, Cz and Pz).

    The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.

    All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.

    Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.

    The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)

  2. Mismatch Negativity (MMN) Frequency

    Time frame: daily

    Mismatch Negativity (MMN) Frequency difference waves at midline electrodes (Fx, Cz and Pz).

    The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.

    All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.

    Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.

    The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)

  3. Mismatch Negativity (MMN) Duration

    Time frame: daily

    Mismatch Negativity (MMN) Duration difference waves at midline electrodes (Fz, Cz and Pz).

    The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.

    All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.

    Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.

    The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2008
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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