NCT02675530CompletedPhase 1
Parallel Effects of Ketamine and Schizophrenia on Neurocognitive Function
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- P300, an ERP measure
Study Overview
Brief Summary
This study investigates the common features of electrophysiological measures in schizophrenia and effects of NMDA antagonist ketamine in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
healthy control
Experimental
Healthy controls will receive electrophysiological assessments before and after NMDA antagonist administration.
Intervention: ketamine (Drug)
Outcomes
Primary Outcomes
P300, an ERP measure
Time Frame: Baseline and repeat assessment following ketamine
Secondary Outcomes
- (Mismatch Negativity) MMN(Baseline and repeat assessment)
Investigators
Study Sites (1)
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