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

Center for Addiction and Mental Health (CAMH)

Status and phase: Completed; Early Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: Existing depression medication treatment; Drug: Sertraline; Drug: N-acetylcysteine (NAC); Drug: Citalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT02269540

137/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Sertraline and n-acetylcysteine

Experimental group

Description:

Sertraline and n-acetylcysteine for seven weeks of treatment

Treatment:

Drug: N-acetylcysteine (NAC)

Drug: Sertraline

Citalopram and n-acetylcysteine

Experimental group

Description:

Citalopram and n-acetylcysteine for seven weeks of treatment

Treatment:

Drug: N-acetylcysteine (NAC)

Drug: Citalopram

Existing medication treatment & NAC

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine (NAC)

Drug: Existing depression medication treatment