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

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ClinicalTrials.gov Identifier: NCT02675530
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ketamine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Parallel Effects of Ketamine and Schizophrenia on Neurocognitive Function
Study Start Date : December 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: healthy control
Healthy controls will receive electrophysiological assessments before and after NMDA antagonist administration.
Drug: ketamine

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 Outcome Measures :
  1. P300, an ERP measure [ Time Frame: Baseline and repeat assessment following ketamine ]

Secondary Outcome Measures :
  1. (Mismatch Negativity) MMN [ Time Frame: Baseline and repeat assessment ]


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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Subjects for the Ketamine experiment(Healthy control experiment):

Inclusion Criteria:

  1. Male or female
  2. 21-45 years old
  3. 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:

  1. Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
  2. Substance abuse, as per clinical judgment, in the past 1 year.
  3. Current or past DSM-IV Axis-I diagnosis.
  4. 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.
  5. 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.
  6. Major current or recent (<6 weeks) stressors.
  7. 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.
  8. Lifetime history of treatment with any psychotropic medications for > 1 month duration suggestive of psychiatric illness.
  9. Current or past Axis I diagnosis of schizophrenia or bipolar disorder in first-degree relatives.
  10. Any medication that could interfere with either the safety of the study and/or the outcome measures.
  11. Use of any illicit substances in the 4 weeks prior to beginning study participation.
  12. Any history indicating learning disability, mental retardation, or attention deficit disorder.
  13. History of head injury with loss of consciousness greater than fifteen minutes.
  14. Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  15. Non-English speaking.
  16. Known sensitivity to ketamine.

Subjects for the Schizophrenia experiment:

Inclusion Criteria for control subjects:

  1. Male or female
  2. 21-45 years old
  3. No past or present Axis I diagnosis, as determined by the SCID-NP

Exclusion Criteria for control subjects:

  1. Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
  2. Substance abuse, as per clinical judgment, in the past 1 year
  3. A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological.
  4. 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.
  5. Axis I diagnosis of schizophrenia or bipolar disorder in first-degree relatives.
  6. History of head injury with loss of consciousness greater than fifteen minutes
  7. Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  8. Non-English speaking.

Inclusion Criteria for patients:

  1. Male or female
  2. 21-45 years old
  3. Diagnosed with DSM-IV schizophrenia based on a SCID-IP interview for patients.
  4. Stable dose of antipsychotic medications for at least 2 weeks prior to beginning study participation.
  5. 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:

  1. Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
  2. Substance abuse, as per clinical judgment, in the past 1 year
  3. A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological.
  4. 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.
  5. History of head injury with loss of consciousness greater than fifteen minutes.
  6. Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  7. Non-English speaking.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675530


Locations
United States, Connecticut
VHA CT
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
AstraZeneca
Investigators
Principal Investigator: Handan Gunduz-Bruce, M.D. Yale Medical School

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02675530     History of Changes
Other Study ID Numbers: 0612002073
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Keywords provided by Yale University:
NMDA
glutamate
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action