Biomarker Assessment of Glutamatergic Target Engagement
2 other identifiers
interventional
65
1 country
3
Brief Summary
The purpose of this study is to assess the relative feasibility of 2 potential functional measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in drug development for psychotic spectrum disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2014
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
February 13, 2018
CompletedAugust 17, 2018
August 1, 2018
1.4 years
May 7, 2014
June 8, 2017
August 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Glutamate + Glutamine (Glx) Response
Compare changes in Glx response to infusion of ketamine vs placebo, as measured by proton magnetic resonance spectroscopy (¹H MRS). Calculated by post-pre changes in the Glx over creatinine ratios, with higher values indicating higher Glx/creatinine ratios.
Day 1
Other Outcomes (1)
Pharmacological Blood-oxygen-level Dependent (pharmacoBOLD) Response
Day 14
Study Arms (2)
ketamine
EXPERIMENTALIV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes
Placebo
PLACEBO COMPARATORPlacebo group will receive normal saline
Interventions
intravenous infusion of saline solution with ketamine
Eligibility Criteria
You may qualify if:
- Age 18-55
- Negative Urine Toxicology
- No present or past psychiatric conditions (including substance abuse or dependence, with the exception of nicotine dependence)
- No family history of schizophrenia in a first-degree relative
You may not qualify if:
- Any current DSM IV Axis I disorder and/or past substance abuse of dependence (nicotine dependence is allowed)
- Any current use of amphetamines, opiates, cocaine, sedative-hypnotics, or cannabis
- Current (i.e., within the last 3 months) treatment with any psychotropic medications
- Pregnancy, lactation, or lack of use of effective birth control
- Presence of positive history of significant medical or neurological illness (including any history of seizure), including high blood pressure (SBP \>140, DBP \>90), low blood pressure (SBP \<100, DBP \<60), orthostatic BP change\>20% (1/3 SBP + 2/3 DBP) or cardiac illness or resting heart rate \>100 or \<50
- History of significant violent behavior
- History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Subjects who have participated prior research ketamine studies will be eligible providing they have participated in no more than 5 previous research ketamine infusions. 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 1 month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.
- Contraindication to MRI scanning, including metal implants or claustrophobia. 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, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects", F.G. Shellock, Lippincott Williams and Wilkins NY 2001
- Color Blindness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of California Davis
Sacramento, California, 95817, United States
Yale University
New Haven, Connecticut, 06511, United States
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
Javitt DC, Carter CS, Krystal JH, Kantrowitz JT, Girgis RR, Kegeles LS, Ragland JD, Maddock RJ, Lesh TA, Tanase C, Corlett PR, Rothman DL, Mason G, Qiu M, Robinson J, Potter WZ, Carlson M, Wall MM, Choo TH, Grinband J, Lieberman JA. Utility of Imaging-Based Biomarkers for Glutamate-Targeted Drug Development in Psychotic Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Jan 1;75(1):11-19. doi: 10.1001/jamapsychiatry.2017.3572.
PMID: 29167877DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marlene Carlson
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A Lieberman, MD
New York State Psychiatric Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Manager
Study Record Dates
First Submitted
May 7, 2014
First Posted
May 9, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
August 17, 2018
Results First Posted
February 13, 2018
Record last verified: 2018-08