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

NCT02269540 | Completed Early Phase 1

• 1 other identifier: 137/2013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hamilton Depression Rating Scale Score

  before and after treatment, 7 weeks on average between measures

• Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)

  before and after treatment, 7 weeks on average between measures

• Blood markers of monoamine oxidase-A fragment level and glutathione level

  before and after treatment, 7 weeks on average between measures

Study Arms (3)

Sertraline and n-acetylcysteine

EXPERIMENTAL

Sertraline and n-acetylcysteine for seven weeks of treatment

Drug: Sertraline; Drug: N-acetylcysteine (NAC)

Citalopram and n-acetylcysteine

EXPERIMENTAL

Citalopram and n-acetylcysteine for seven weeks of treatment

Drug: Citalopram; Drug: N-acetylcysteine (NAC)

Existing medication treatment & NAC

EXPERIMENTAL

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

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

Interventions

Sertraline DRUG

selective serotonin reuptake inhibitor

Also known as: Zoloft

Sertraline and n-acetylcysteine

Citalopram DRUG

selective serotonin reuptake inhibitor

Also known as: Celexa

Citalopram and n-acetylcysteine

N-acetylcysteine (NAC) DRUG

natural health product

Citalopram and n-acetylcysteine; Existing medication treatment & NAC; Sertraline and n-acetylcysteine

Existing depression medication treatment 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

Existing medication treatment & NAC

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-IV diagnosis of current major depressive episode and major depressive disorder
• Hamilton Depression Rating Scale score of at least 20

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Research Imaging Centre, Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline; Citalopram; Acetylcysteine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey H Meyer, MD, PhD

  Centre for Addiction and Mental Health; University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Canada Research Chair

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

CA (1)