PET Imaging of mGLuR5 With Drug Challenge

Completed · Not applicable

Conditions studied: Major Depressive Disorder, Post-Traumatic Stress Disorder (PTSD)

In brief

This study is designed to look at that involvement of a process in the brain called the glutamate system in depression. Participants will undergo a screening session, up to two functional Magnetic Resonance Imaging (fMRI) scans, and up to three Positron Emission Tomography (PET) scans, as well as cognitive testing at each scan session. For one of the PET scans, a drug (either ketamine or n-acetyl cysteine) will be administered. Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine (NAC) will lead to a decrease in mGluR5. Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills after drug challenge. Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in MRI measures post drug challenge as compared to baseline, signifying synaptogenesis. Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5 availability due to differences in ABP688 radiotracer infusion.

Key facts

Study ID

NCT01691092

Run by

Yale University

People needed

79

Starts

2012-06-01

Expected to finish

2016-02-01

Last updated by the study team

2017-04-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Connecticut Mental Health Center — New Haven, Connecticut, United States
• Yale University Magnetic Resonance Research Center (MRRC) — New Haven, Connecticut, United States
• Yale University PET Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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