Neuroimaging MAO-B in Medication Free TR-MDD Using Novel... | NCT02153281

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

NCT02153281

Sponsor

Centre for Addiction and Mental Health

Status

Completed

Last Update Posted

May 24, 2019Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

phenelzine treatment

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

May 2019Actual

Completion Date

May 2019Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Jun 2, 2014

First Posted Date

Jun 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2019

Last Update Posted Date

May 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeff Meyer, Head Neurochemical Imaging in Mood Disorders, Centre for Addiction and Mental HealthPrincipal Investigator

Lead Sponsor

Centre for Addiction and Mental HealthOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phenelzine treatment	Experimental	Subjects will undergo a PET and MRI scan before and after the treatment.	Other: phenelzine treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phenelzine treatment	Other	Subjects will have a PET and MRI scan before and after treatment with phenelzine.	Phenelzine treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey H. Meyer, MD, PhD	Research Imaging Centre, Centre for Addiction and Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Addiction and Mental Health		Toronto	Ontario	M5T 1R8	Canada

References Module

Citations

Not provided

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms