Clincosm LogoSign in Get a demo

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

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Completed
CT.gov ID
NCT02269540
Collaborator
(none)
10
Enrollment
1
Location
3
Arms
45
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sertraline and n-acetylcysteine

Sertraline and n-acetylcysteine for seven weeks of treatment

Drug: Sertraline
selective serotonin reuptake inhibitor
Other Names:
  • Zoloft

    • Drug: N-acetylcysteine (NAC)
    natural health product
    Experimental: Citalopram and n-acetylcysteine

    Citalopram and n-acetylcysteine for seven weeks of treatment

    Drug: Citalopram
    selective serotonin reuptake inhibitor
    Other Names:
  • Celexa

    • Drug: N-acetylcysteine (NAC)
    natural health product
    Experimental: Existing medication treatment & NAC

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

    Drug: N-acetylcysteine (NAC)
    natural health product

    Drug: Existing depression medication treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. MAO-A distribution volume with positron emission tomography [before and after treatment, 7 weeks on average between measures]

      Treatment take 1 week for titration and 6 weeks at full dose=7weeks average

    Secondary Outcome Measures

    1. Hamilton Depression Rating Scale Score [before and after treatment, 7 weeks on average between measures]

      Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

    2. Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels) [before and after treatment, 7 weeks on average between measures]

      Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

    3. Blood markers of monoamine oxidase-A fragment level and glutathione level [before and after treatment, 7 weeks on average between measures]

      Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Imaging Centre, Centre for Addiction and Mental Health Toronto Ontario Canada M5T 1R8

    Sponsors and Collaborators

    • Centre for Addiction and Mental Health

    Investigators

    • Principal Investigator: Jeffrey H Meyer, MD, PhD, Centre for Addiction and Mental Health; University of Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jeff Meyer, Canada Research Chair, Centre for Addiction and Mental Health
    ClinicalTrials.gov Identifier:
    NCT02269540
    Other Study ID Numbers:
    • 137/2013
    First Posted:
    Oct 21, 2014
    Last Update Posted:
    May 24, 2019
    Last Verified:
    May 1, 2019
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Acetylcysteine
    Sertraline
    Citalopram
    N-monoacetylcystine

    Study Results

    No Results Posted as of May 24, 2019