- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02153281
Neuroimaging MAO-B in Medication Free TR-MDD Using Novel Tracer (DETB)
May 22, 2019 updated by: Jeff Meyer, Centre for Addiction and Mental Health
Neuroimaging MAO-B in Medication Free and Treatment Resistant Major Depressive Disorder Using Novel MAO-B Tracer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects will receive a PET and MRI scan before and after treatment with phenelzine.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 1R8
- Center for Addiction and Mental Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phenelzine treatment
Subjects will undergo a PET and MRI scan before and after the treatment.
|
Subjects will have a PET and MRI scan before and after treatment with phenelzine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MAO-B VT levels measured with PET in MDE secondary to MDD
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey H. Meyer, MD, PhD, Research Imaging Centre, Centre for Addiction and Mental Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
May 1, 2019
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
March 28, 2014
First Submitted That Met QC Criteria
June 2, 2014
First Posted (Estimate)
June 3, 2014
Study Record Updates
Last Update Posted (Actual)
May 24, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DETB-071-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on phenelzine treatment
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
EpiAxis TherapeuticsThe Canberra Hospital; Southern Medical Day Care Centre; Liverpool Cancer Therapy...CompletedMetastatic Breast CancerAustralia
-
Boehringer IngelheimTerminated
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); The Wayne D. Kuni and Joan E. Kuni FoundationTerminatedProstate Adenocarcinoma | Recurrent Prostate Carcinoma | Metastatic Prostatic Adenocarcinoma | Hormone-Resistant Prostate CancerUnited States
-
Amarantus BioScience Holdings, Inc.CompletedSchizophrenia | Cognitive ImpairmentUnited States
-
CelgeneCompletedHealthy VolunteerUnited States
-
PfizerCompleted
-
PfizerCompleted
-
Chiesi Farmaceutici S.p.A.Completed
-
CelgeneCompletedHealthy VolunteersUnited States