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

May 22, 2019 updated by: Jeff Meyer, Centre for Addiction and Mental Health

Neuroimaging MAO-B in Medication Free and Treatment Resistant Major Depressive Disorder Using Novel MAO-B Tracer

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Subjects will receive a PET and MRI scan before and after treatment with phenelzine.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Center for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phenelzine treatment
Subjects will undergo a PET and MRI scan before and after the treatment.
Subjects will have a PET and MRI scan before and after treatment with phenelzine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MAO-B VT levels measured with PET in MDE secondary to MDD
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeffrey H. Meyer, MD, PhD, Research Imaging Centre, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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