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PET Imaging of mGLuR5 With Drug Challenge

This study is currently recruiting participants.
Verified September 2012 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01691092
First received: September 19, 2012
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  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.


Condition
Major Depressive Disorder

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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Yale University:

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: June 2022
Groups/Cohorts
MDD
40 currently depressed subjects
Healthy Control
40 psychiatrically healthy subjects

  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

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

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

Contacts
Contact: Nicole F DellaGioia, MA (203)974-7872 nicole.dellagioia@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Nicole DellaGioia, MA     203-974-7872     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: September 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Depression
Ketamine
PET

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013