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

NCT02675530 | Completed Phase 1

• 1 other identifier: 0612002073
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

NMDA; glutamate; schizophrenia

Outcome Measures

Primary Outcomes (1)

• P300, an ERP measure

  Baseline and repeat assessment following ketamine

Secondary Outcomes (1)

• (Mismatch Negativity) MMN

  Baseline and repeat assessment

Study Arms (1)

healthy control

EXPERIMENTAL

Healthy controls will receive electrophysiological assessments before and after NMDA antagonist administration.

Drug: ketamine

Interventions

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

healthy control

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• AstraZeneca: collaborator

Study Sites (1)

VHA CT

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Handan Gunduz-Bruce, M.D.

  Yale Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: February 5, 2016
• Study Start: December 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (1)