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A New Treatment Approach for Major Depressive Disorder Based Upon Targeting Monoamine Oxidase A (MAO-A)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Sertraline
Citalopram
N-acetylcysteine (NAC)
Existing depression medication treatment
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV diagnosis of current major depressive episode and major depressive disorder
  • Hamilton Depression Rating Scale score of at least 20

Exclusion Criteria:

  • Comorbid axis I or II disorders
  • Antidepressant use in past 6 months
  • Current use of herbal remedies
  • Cigarette smoking
  • Drug or medication use within past 8 weeks
  • History of substance abuse/neurotoxin use
  • History of psychotic symptoms
  • History of CNS medical illness
  • Current substance use
  • Test positive on pregnancy test (women)

Sites / Locations

  • Research Imaging Centre, Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sertraline and n-acetylcysteine

Citalopram and n-acetylcysteine

Existing medication treatment & NAC

Arm Description

Sertraline and n-acetylcysteine for seven weeks of treatment

Citalopram and n-acetylcysteine for seven weeks of treatment

Existing depression medication treatment and n-acetylcysteine for seven weeks of treatment

Outcomes

Primary Outcome Measures

MAO-A distribution volume with positron emission tomography
Treatment take 1 week for titration and 6 weeks at full dose=7weeks average

Secondary Outcome Measures

Hamilton Depression Rating Scale Score
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Blood markers of monoamine oxidase-A fragment level and glutathione level
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

Full Information

First Posted
August 11, 2014
Last Updated
May 22, 2019
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02269540
Brief Title
A New Treatment Approach for Major Depressive Disorder Based Upon Targeting Monoamine Oxidase A (MAO-A)
Official Title
A New Biomarker-Based Approach Towards Developing Improved Treatment for Major Depressive Disorder (MDD) Based Upon Targeting Monoamine Oxidase A (MAO-A)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will be looking at MAO-A density before and after seven weeks of treatment with an antidepressant and dietary supplement. MAO-A is an enzyme that breaks down brain chemicals that regulate mood. MAO-A density is elevated in patients with major depressive episodes (MDE) secondary to major depressive disorder (MDD). Many remain treatment resistant with common antidepressant treatments and we think it may be due to poor targeting of brain pathologies. We want to test if adding a dietary supplement may normalize MAO-A.
Detailed Description
All subjects are getting the combined treatment of a selective serotonin reuptake inhibitor and the dietary supplement. There are two possible selective serotonin reuptake inhibitor treatments but the dietary supplement remains the same. No subjects are receiving the selective serotonin reuptake inhibitor alone and no subjects are receiving the dietary supplement alone. The dietary supplement is called n-acetylcysteine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertraline and n-acetylcysteine
Arm Type
Experimental
Arm Description
Sertraline and n-acetylcysteine for seven weeks of treatment
Arm Title
Citalopram and n-acetylcysteine
Arm Type
Experimental
Arm Description
Citalopram and n-acetylcysteine for seven weeks of treatment
Arm Title
Existing medication treatment & NAC
Arm Type
Experimental
Arm Description
Existing depression medication treatment and n-acetylcysteine for seven weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
selective serotonin reuptake inhibitor
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa
Intervention Description
selective serotonin reuptake inhibitor
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine (NAC)
Intervention Description
natural health product
Intervention Type
Drug
Intervention Name(s)
Existing depression medication treatment
Intervention Description
Continuation of depression medication treatment already taken prior to study enrollment except for drugs with affinity for MAO-A or potentially influencing MAO-A levels, including phenelzine, tranylcypromine, moclobemide, cytomel and lithium
Primary Outcome Measure Information:
Title
MAO-A distribution volume with positron emission tomography
Description
Treatment take 1 week for titration and 6 weeks at full dose=7weeks average
Time Frame
before and after treatment, 7 weeks on average between measures
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale Score
Description
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Time Frame
before and after treatment, 7 weeks on average between measures
Title
Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)
Description
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Time Frame
before and after treatment, 7 weeks on average between measures
Title
Blood markers of monoamine oxidase-A fragment level and glutathione level
Description
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Time Frame
before and after treatment, 7 weeks on average between measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of current major depressive episode and major depressive disorder Hamilton Depression Rating Scale score of at least 20 Exclusion Criteria: Comorbid axis I or II disorders Antidepressant use in past 6 months Current use of herbal remedies Cigarette smoking Drug or medication use within past 8 weeks History of substance abuse/neurotoxin use History of psychotic symptoms History of CNS medical illness Current substance use Test positive on pregnancy test (women)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey H Meyer, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health; University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Imaging Centre, Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.camh.ca/en/research
Description
The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.

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A New Treatment Approach for Major Depressive Disorder Based Upon Targeting Monoamine Oxidase A (MAO-A)

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