Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

PET Imaging of mGLuR5 With Drug Challenge

This study is designed to look at the involvement of the glutamate system in depression using PET/fMRI; n=79 with a ketamine drug challenge during one PET scan.

Target Enrollment
79 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

Participants undergo screening, up to two fMRI scans and up to three PET scans with cognitive testing at each session; one PET scan includes a drug challenge to provoke glutamate release.

Primary aims are to determine the acute effect of medication-induced glutamate release on mGluR5 availability and to assess cognitive effects and potential synaptogenesis measured by PET and MRI post-challenge.

Hypotheses include decreased mGluR5 after ketamine/NAC, improvements in memory and attention after challenge, and detectable increases in mGluR5 availability and MRI changes indicating synaptogenesis.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

All subjects receive ketamine to induce glutamate release for PET challenge.

Interventions

  • Ketamine
    via IV• single dose

    Administered prior to one PET scan to induce glutamate release

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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 Details

Locations

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

Your Library