PET Imaging of mGluR5 With Drug Challenge
Ketamine
Trauma and Stressor Related Disorders+7
+ Behavior
+ Mental Disorders
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.79 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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 MapsYale University Magnetic Resonance Research Center (MRRC)
New Haven, United StatesYale University PET Center
New Haven, United States