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
  Purpose

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.


Condition
Major Depressive Disorder
Post-Traumatic Stress Disorder (PTSD)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: PET Imaging of mGluR5 With Drug Challenge

Further study details as provided by Yale University:

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: June 2022
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691092

Contacts
Contact: Nicole F DellaGioia, MA (203)737-6884 nicole.dellagioia@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Nicole DellaGioia, MA    203-737-6884    nicole.dellagioia@yale.edu   
Yale University PET Center Recruiting
New Haven, Connecticut, United States, 06519
Yale University Magnetic Resonance Research Center (MRRC) Recruiting
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Irina Esterlis, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691092     History of Changes
Other Study ID Numbers: 1111009365
Study First Received: September 19, 2012
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Depression
Ketamine
PET
PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Anxiety Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014