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Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)

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ClinicalTrials.gov Identifier: NCT04589208
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 25, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joshua Kantrowitz, New York State Psychiatric Institute

Brief Summary:

50 healthy volunteers (HV) will participate in 2 identical ketamine-induced pharmacoBOLD (phBOLD) sessions at least 7 days apart. On both days, clinical assessments will be performed following removal of the subject from the scanner.

HV will be discharged home after clearance by the study physician. This study will assign ketamine doses in successive 10 subject cohorts. The ketamine dose for the 1st cohort will start at 0.08 mg/kg. For subsequent cohorts, the bolus will be successively reduced or increased by 0.02 mg/kg (n=10/dose) to determine the lowest dose of ketamine that still produces a robust phBOLD response.

The study will be subject and rater blind, i.e. subjects and raters, will be blinded to the treatment (ketamine dose) group.

The study physician will be aware of the ketamine dose, and ketamine dose will be the same for both sessions.

Subjects will not be told what the exact ketamine dose they will receive, but it will be based on their weight and will be no higher than 0.08 mg/kg.


Condition or disease Intervention/treatment Phase
Healthy Drug: Ketamine Hydrochloride Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Single blind (rater, participant will be unaware of dose). Subjects will be assigned ketamine doses in 10 subject cohorts
Masking: None (Open Label)
Masking Description:

The study will be subject and rater blind, i.e. subjects and raters, will be blinded to the treatment (ketamine dose) group.

The study physician will be aware of the ketamine dose, and ketamine dose will be the same for both sessions.

Subjects will not be told what the exact ketamine dose they will receive, but it will be based on their weight and will be no higher than 0.08 mg/kg.

Primary Purpose: Other
Official Title: Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketamine
ketamine
Drug: Ketamine Hydrochloride
We will assign ketamine doses in successive 10 subject cohorts. The ketamine dose for the 1st cohort will start at 0.08 mg/kg. For subsequent cohorts, the bolus will be successively reduced or increased by 0.02 mg/kg (n=10/dose) to determine the lowest dose of ketamine that still produces a robust phBOLD response




Primary Outcome Measures :
  1. PhBOLD [ Time Frame: Compare within day changes in phBOLD in response to infusion of ketamine, as measured by resting state fMRI. Calculated by post-pre changes, with higher values indicating higher response. Two scans will be completed, 7 days apart ]
    Pharmacological Blood-oxygen-level Dependent (phBOLD) Response to ketamine

  2. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Compare within day changes in BPRS in response to infusion of ketamine, as measured by the clinical scale. Calculated by post-pre changes, with higher values indicating higher response. Two scans will be completed, 7 days apart ]
    Clinical rating scale assessing common psychiatric symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 18-55
  2. Medically healthy, as assessed by study physician
  3. Capable of understanding the study procedures and able to provide informed consent
  4. Eligible men and women must agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant; a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible.

Exclusion Criteria:

  1. Current or past Axis I psychiatric history (including Substance Use Disorder/Alcohol Use Disorder, with the exception of nicotine use disorder)
  2. Positive urine toxicology
  3. History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Subjects who have participated in prior research ketamine studies will be eligible. Subjects can have infusions not more frequently than biweekly, and not more than 1/month on average, therefore subjects entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.
  4. History of first-degree relative with schizophrenia
  5. Pregnancy or breast-feeding. This exclusion criterion applies only to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal). Must test negative for pregnancy at the time of screening based on a serum pregnancy test.
  6. History of violence, including any history of using a gun, knife, or other weapon with intent to harm someone, as well as a more than one physical fight without a weapon after the age of 18 years old (not including fights that happen during sports competition).
  7. Presence or positive history of significant medical illness, including renal problems (GFR<60), high blood pressure (defined as systolic blood pressure (SBP) > 140 or diastolic blood pressure (DBP) > 90), low blood pressure (SBP < 100, DBP < 60), orthostatic blood pressure at baseline (change in mean arterial pressure [1/3 systolic + 2/3 diastolic] of > 20%), cardiac illness, or clinically significant abnormal screening labs, as determined by the site physician.
  8. Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator.
  9. Presence or positive history of neurological illness, including seizures, mental retardation or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS), or history of significant head injury.
  10. Metal implants, pacemaker, other metal (e.g., shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MR scan.
  11. Medicinal patch, unless removed prior to the MR scan
  12. Claustrophobia
  13. Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications, and stimulants. We will exclude any subject who requires treatment with any psychotropic medication from one of these classes.

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): NCT04589208


Contacts
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Contact: Marlene Carlson 6467748436 Marlene.Carlson@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Recruiting
New York, New York, United States, 10023
Contact: Marlene M Carlson, MS    646-774-8436    Marlene.Carlson@nyspi.columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
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Responsible Party: Joshua Kantrowitz, Associate Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT04589208    
Other Study ID Numbers: 8063
R01MH123142-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NIMH Data Archive:
Supporting Materials: Study Protocol
Time Frame: after publication
Access Criteria: Qualified reseaerchers
URL: https://nda.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Joshua Kantrowitz, New York State Psychiatric Institute:
schizophrenia
Additional relevant MeSH terms:
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Psychotic Disorders
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