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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

Tracking Information
First Submitted Date  ICMJE May 17, 2012
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
P300, an ERP measure [ Time Frame: Baseline and repeat assessment following ketamine ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
(Mismatch Negativity) MMN [ Time Frame: Baseline and repeat assessment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parallel Effects of Schizophrenia and N-methyl-D-aspartate (NMDA) Antagonism
Official Title  ICMJE Parallel Effects of Ketamine and Schizophrenia on Neurocognitive Function
Brief Summary This study investigates the common features of electrophysiological measures in schizophrenia and effects of NMDA antagonist ketamine in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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

Study Arms  ICMJE Experimental: healthy control
Healthy controls will receive electrophysiological assessments before and after NMDA antagonist administration.
Intervention: Drug: ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2016)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02675530
Other Study ID Numbers  ICMJE 0612002073
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Handan Gunduz-Bruce, M.D. Yale Medical School
PRS Account Yale University
Verification Date February 2016

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