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Neuroimaging MAO-B in Medication Free TR-MDD Using Novel Tracer (DETB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153281
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jeff Meyer, Centre for Addiction and Mental Health

Tracking Information
First Submitted Date  ICMJE March 28, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date May 24, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
MAO-B VT levels measured with PET in MDE secondary to MDD [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroimaging MAO-B in Medication Free TR-MDD Using Novel Tracer
Official Title  ICMJE Neuroimaging MAO-B in Medication Free and Treatment Resistant Major Depressive Disorder Using Novel MAO-B Tracer
Brief Summary The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution volume (VT), after phenelzine treatment and if so to what extent.
Detailed Description Subjects will receive a PET and MRI scan before and after treatment with phenelzine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Other: phenelzine treatment
Subjects will have a PET and MRI scan before and after treatment with phenelzine.
Study Arms  ICMJE Experimental: Phenelzine treatment
Subjects will undergo a PET and MRI scan before and after the treatment.
Intervention: Other: phenelzine treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
15
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-80 years of age
  • good physical health
  • Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of current major depressive episode (MDE)
  • DSM-IV diagnosis of major depressive disorder (MDD) verified by SCID for DSM-IV and a psychiatric consultation
  • greater than 17 on the 17 item HDRS (Hamilton Depression Rating Scale).
  • history of non-response to several different antidepressant classes

Exclusion Criteria:

  • herbal, drug or medication use (that affect CNS function)
  • suicide attempts
  • drug or medication use within eight weeks (+5 half lives of medication)
  • history of substance abuse or any neurotoxin use
  • history of psychotic symptoms
  • history of central nervous system (CNS) medical illness
  • current substance abuse
  • test positive on pregnancy test (for women)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153281
Other Study ID Numbers  ICMJE DETB-071-13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jeff Meyer, Centre for Addiction and Mental Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre for Addiction and Mental Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey H. Meyer, MD, PhD Research Imaging Centre, Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date May 2019

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