PET Imaging of mGLuR5 With Drug Challenge

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01691092
First received: September 19, 2012
Last updated: June 26, 2014
Last verified: June 2014

September 19, 2012
June 26, 2014
June 2012
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01691092 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PET Imaging of mGLuR5 With Drug Challenge
PET Imaging of mGluR5 With Drug Challenge

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 fMRI scans, and up to three 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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Group 1: psychiatrically healthy subjects Group 2: depressed subjects with uni- or bipolar depression who have been antidepressant free Group 3: subjects meeting criteria for Post-Traumatic Stress Disorder (PTSD) Group 4: subjects with history of trauma (meeting criterion A of PTSD but not a full diagnosis of PTSD)

  • Major Depressive Disorder
  • Post-Traumatic Stress Disorder (PTSD)
Not Provided
  • MDD
    40 currently depressed subjects
  • Healthy Control
    40 psychiatrically healthy subjects
  • PTSD
    10 PTSD subjects
  • Trauma control
    10 subjects with history of trauma (meeting criterion A of PTSD but not a full diagnosis of PTSD)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2022
Not Provided

Inclusion Criteria:

  • 18-65 years old
  • English speaking
  • No other 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 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-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 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
Both
18 Years to 65 Years
Yes
Contact: Nicole F DellaGioia, MA (203)737-6884 nicole.dellagioia@yale.edu
United States
 
NCT01691092
1111009365
No
Yale University
Yale University
Not Provided
Principal Investigator: Irina Esterlis, PhD Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP