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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sertraline and n-acetylcysteine

Sertraline and n-acetylcysteine for seven weeks of treatment

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

selective serotonin reuptake inhibitor

N-acetylcysteine (NAC)

Intervention Type DRUG

natural health product

Citalopram and n-acetylcysteine

Citalopram and n-acetylcysteine for seven weeks of treatment

Group Type EXPERIMENTAL

Citalopram

Intervention Type DRUG

selective serotonin reuptake inhibitor

N-acetylcysteine (NAC)

Intervention Type DRUG

natural health product

Existing medication treatment & NAC

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

Group Type EXPERIMENTAL

N-acetylcysteine (NAC)

Intervention Type DRUG

natural health product

Existing depression medication treatment

Intervention Type DRUG

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

Interventions

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Sertraline

selective serotonin reuptake inhibitor

Intervention Type DRUG

Citalopram

selective serotonin reuptake inhibitor

Intervention Type DRUG

N-acetylcysteine (NAC)

natural health product

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Zoloft Celexa

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No