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

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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

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: phenelzine treatment Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuroimaging MAO-B in Medication Free and Treatment Resistant Major Depressive Disorder Using Novel MAO-B Tracer
Study Start Date : June 2014
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Phenelzine

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




Primary Outcome Measures :
  1. MAO-B VT levels measured with PET in MDE secondary to MDD [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153281


Locations
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Canada, Ontario
Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Jeffrey H. Meyer, MD, PhD Research Imaging Centre, Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: Jeff Meyer, Head Neurochemical Imaging in Mood Disorders, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02153281     History of Changes
Other Study ID Numbers: DETB-071-13
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Keywords provided by Jeff Meyer, Centre for Addiction and Mental Health:
Depression
Positron Emission Tomography (PET)
MAO-B
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Phenelzine
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action