NCT02153281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

4.9 years

First QC Date

March 28, 2014

Last Update Submit

May 22, 2019

Conditions

Major Depressive Disorder

Keywords

DepressionPositron Emission Tomography (PET)MAO-B

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Study Arms (1)

Phenelzine treatment

EXPERIMENTAL

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

Other: phenelzine treatment

Interventions

phenelzine treatmentOTHER

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

Phenelzine treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Jeffrey H. Meyer, MD, PhD

    Research Imaging Centre, Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Neurochemical Imaging in Mood Disorders

Study Record Dates

First Submitted

March 28, 2014

First Posted

June 3, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

CA(1)