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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269540
• Other study ID #: 137/2013
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2014
• Est. completion date: July 2018

Study information

• Verified date: May 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Sertraline
selective serotonin reuptake inhibitor
• Citalopram
selective serotonin reuptake inhibitor
• N-acetylcysteine (NAC)
natural health product
• 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

Locations

Country	Name	City	State
Canada	Research Imaging Centre, Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAO-A distribution volume with positron emission tomography	Treatment take 1 week for titration and 6 weeks at full dose=7weeks average	before and after treatment, 7 weeks on average between measures
Secondary	Hamilton Depression Rating Scale Score	Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average	before and after treatment, 7 weeks on average between measures
Secondary	Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)	Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average	before and after treatment, 7 weeks on average between measures
Secondary	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	before and after treatment, 7 weeks on average between measures

External Links

•   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.