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CompletedNot applicableResults posted

PET Imaging of mGLuR5 With Drug Challenge

NCT01691092 · Yale University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
79
Target enrolment
3
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging

    Measured over 1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

3 study sites

FacilityCityRegionCountry
Connecticut Mental Health CenterNew HavenConnecticutUnited States
Yale University Magnetic Resonance Research Center (MRRC)New HavenConnecticutUnited States
Yale University PET CenterNew HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT01691092 on ClinicalTrials.gov →

Last updated in the registry 2017-04-21. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits