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Completed

NCT Number: NCT02675530

Parallel Effects of Schizophrenia and N-methyl-D-aspartate (NMDA) Antagonism

This study investigates the common features of electrophysiological measures in schizophrenia and effects of NMDA antagonist ketamine in healthy volunteers.

Completed

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VHA CT

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

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

Subjects for the Ketamine experiment(Healthy control experiment):

Inclusion criteria

  • Male or female
  • 21-45 years old
  • Deemed healthy by the Structured Clinical Interview for DSM-NP (SCID-NP) and collateral information. Subjects will need to provide the name of a person, preferably a family member, whom the research team can contact to corroborate information.

Exclusion criteria

  • Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
  • Substance abuse, as per clinical judgment, in the past 1 year.
  • Current or past DSM-IV Axis-I diagnosis.
  • A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up.
  • A hearing deficit greater than 30 dB in both ears detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) at screening.
  • Major current or recent (<6 weeks) stressors.
  • History of counseling, except if counseling was for a life circumstance disorder (e.g., bereavement, divorce) or in the opinion of the investigator, is not clinically significant.
  • Lifetime history of treatment with any psychotropic medications for > 1 month duration suggestive of psychiatric illness.
  • Current or past Axis I diagnosis of schizophrenia or bipolar disorder in first-degree relatives.
  • Any medication that could interfere with either the safety of the study and/or the outcome measures.
  • Use of any illicit substances in the 4 weeks prior to beginning study participation.
  • Any history indicating learning disability, mental retardation, or attention deficit disorder.
  • History of head injury with loss of consciousness greater than fifteen minutes.
  • Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  • Non-English speaking.
  • Known sensitivity to ketamine.

Subjects for the Schizophrenia experiment:

Inclusion criteria

for control subjects:

  • Male or female
  • 21-45 years old
  • No past or present Axis I diagnosis, as determined by the SCID-NP

Exclusion criteria

for control subjects:

  • Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
  • Substance abuse, as per clinical judgment, in the past 1 year
  • A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological.
  • A hearing deficit greater than 30dB in both ears detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) at screening.
  • Axis I diagnosis of schizophrenia or bipolar disorder in first-degree relatives.
  • History of head injury with loss of consciousness greater than fifteen minutes
  • Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  • Non-English speaking.

Inclusion criteria

for patients:

  • Male or female
  • 21-45 years old
  • Diagnosed with DSM-IV schizophrenia based on a SCID-IP interview for patients.
  • Stable dose of antipsychotic medications for at least 2 weeks prior to beginning study participation.
  • Score either in the 1-3 (high functioning) range or in the 5-7 (low functioning) range of the Global Functioning Scale from the MSIF based on a screening interview.

Exclusion criteria

  • Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
  • Substance abuse, as per clinical judgment, in the past 1 year
  • A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological.
  • A hearing deficit greater than 30dB in both ears detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) at screening.
  • History of head injury with loss of consciousness greater than fifteen minutes.
  • Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  • Non-English speaking.

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Treatment and study plan

ketamine

Drug

For healthy volunteer arm of study, NMDA antagonist ketamine will be administered. 0.23 mg/kg over 1 minute, followed by 0.58 mg/kg/hour for 30 minutes, followed by 0.29 mg/kg/hour for 50 minutes.

No drug administration for patients with schizophrenia

Primary outcomes

  1. P300, an ERP measure

    Time frame: Baseline and repeat assessment following ketamine

Secondary outcomes

  1. (Mismatch Negativity) MMN

    Time frame: Baseline and repeat assessment

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Parallel Effects of Ketamine and Schizophrenia on Neurocognitive Function

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 5, 2016
Registry last updated
Feb 5, 2016

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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