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

A New Biomarker-Based Approach Towards Developing Improved Treatment for Major Depressive Disorder (MDD) Based Upon Targeting Monoamine Oxidase A (MAO-A)

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02269540
Enrollment
10
Registered
2014-10-21
Start date
2014-10-31
Completion date
2018-07-31
Last updated
2019-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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.

Interventions

DRUGSertraline

selective serotonin reuptake inhibitor

DRUGCitalopram

selective serotonin reuptake inhibitor

DRUGN-acetylcysteine (NAC)

natural health product

DRUGExisting 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

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
MAO-A distribution volume with positron emission tomographybefore and after treatment, 7 weeks on average between measuresTreatment take 1 week for titration and 6 weeks at full dose=7weeks average

Secondary

MeasureTime frameDescription
Hamilton Depression Rating Scale Scorebefore and after treatment, 7 weeks on average between measuresTreatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)before and after treatment, 7 weeks on average between measuresTreatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Blood markers of monoamine oxidase-A fragment level and glutathione levelbefore and after treatment, 7 weeks on average between measuresTreatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026