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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
phenelzine treatment
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Positron Emission Tomography (PET), MAO-B

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Center for Addiction and Mental Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phenelzine treatment

Arm Description

Subjects will undergo a PET and MRI scan before and after the treatment.

Outcomes

Primary Outcome Measures

MAO-B VT levels measured with PET in MDE secondary to MDD

Secondary Outcome Measures

Full Information

First Posted
March 28, 2014
Last Updated
May 22, 2019
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02153281
Brief Title
Neuroimaging MAO-B in Medication Free TR-MDD Using Novel Tracer
Acronym
DETB
Official Title
Neuroimaging MAO-B in Medication Free and Treatment Resistant Major Depressive Disorder Using Novel MAO-B Tracer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Positron Emission Tomography (PET), MAO-B

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phenelzine treatment
Arm Type
Experimental
Arm Description
Subjects will undergo a PET and MRI scan before and after the treatment.
Intervention Type
Other
Intervention Name(s)
phenelzine treatment
Intervention Description
Subjects will have a PET and MRI scan before and after treatment with phenelzine.
Primary Outcome Measure Information:
Title
MAO-B VT levels measured with PET in MDE secondary to MDD
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey H. Meyer, MD, PhD
Organizational Affiliation
Research Imaging Centre, Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.camh.ca/research
Description
Information about research at the Centre for Addiction and Mental Health

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

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