Completed

PET Imaging of mGluR5 With Drug Challenge

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What is being tested

Ketamine

Drug
Who is being recruted

Trauma and Stressor Related Disorders+7

+ Behavior

+ Mental Disorders

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorYale University
Last updated: April 21, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

Aim 1: To determine the acute effect of medication-induced glutamate release on mGluR5 availability in human subjects. Hypothesis 1: We hypothesize administration of ketamine or n-acetylcysteine (NAC) will lead to a decrease in mGluR5 availability. Aim 2: To determine if glutamate release via administration of ketamine or NAC has pro cognitive benefits. Hypothesis 2: We hypothesize an improvement in memory and attentional skills after drug challenge. Aim 3: To determine if there is synaptogenesis detectable by PET and MRI post ketamine or NAC within a week of drug challenge (at the time of greatest antidepressant response). Hypothesis 3: We hypothesize an increase in mGluR5 availability and change in MRI measures, post drug challenge as compared to baseline, signifying synaptogenesis. Aim 4: To determine if there is a difference in reduction of mGluR5 availability after ketamine administration when radiotracer is administered bolus as compared to bolus to constant infusion in the same subjects (ABP688 radiotracer only). Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5 availability due to differences in ABP688 radiotracer infusion.

Principal SponsorYale University
Last updated: April 21, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

79 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersBehaviorMental DisordersBehavioral SymptomsDepressive DisorderMood DisordersStress Disorders, TraumaticDepressionDepressive Disorder, MajorStress Disorders, Post-Traumatic

Criteria

Inclusion Criteria: 18-65 years old English speaking No other Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) diagnosis present, besides required as below. Inclusion criteria for depressed subjects clinical diagnosis of a current or past depressive episode medication free for at least 2 weeks Score >16 on Hamilton Depression Rating Scale (HDRS) if currently depressed or <11 if not currently depressed treatment or non-treatment seeking who understand that this study is for research purposes only Inclusion criteria for healthy controls no current, or history of, any DSM-IV diagnosis no first-degree relative with history of psychotic, mood, or anxiety disorder Inclusion criteria for PTSD subjects current Post-Traumatic Stress Disorder, as determined by the Structured Clinical Interview for DSM-IV-Text Revision (TR) (SCID) patient research edition Clinician Administered PTSD Scale for DSM-IV-TR (CAPS) score of 50 or higher Inclusion criteria for trauma control subjects -history of trauma (meeting the criterion A of PTSD but not a full diagnosis of PTSD) Exclusion Criteria: Current or past significant medical, neurological, or metabolic disorder or loss of consciousness for 5 minutes or more active, significant suicidal ideation implanted metallic devices or any Magnetic Resonance (MR) contraindications women who are pregnant or breastfeeding met DSM-IV criteria for alcohol/illicit substance dependence in their life-time or met alcohol/illicit substance abuse within past year history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year blood donation within eight weeks of the start of the study radiation exposure at work that precludes study participation blood pressure >140/80

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All subjects will receive ketamine

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Connecticut Mental Health Center

New Haven, United StatesOpen Connecticut Mental Health Center in Google Maps

Yale University Magnetic Resonance Research Center (MRRC)

New Haven, United States

Yale University PET Center

New Haven, United States
Completed3 Study Centers