Clinical trial NCT02269540: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Major Depressive Disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: MAO-A distribution volume with positron emission tomography
timeFrame: before and after treatment, 7 weeks on average between measures
Secondary outcomes:
measure: Hamilton Depression Rating Scale Score
timeFrame: before and after treatment, 7 weeks on average between measures
measure: Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)
timeFrame: before and after treatment, 7 weeks on average between measures
measure: Blood markers of monoamine oxidase-A fragment level and glutathione level
timeFrame: before and after treatment, 7 weeks on average between measures
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Research Imaging Centre, Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health; University of Toronto
name: Jeffrey H Meyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: