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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153281
Other study ID # DETB-071-13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date May 2019

Study information

Verified date May 2019
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Canada Center for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary MAO-B VT levels measured with PET in MDE secondary to MDD 8 weeks
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