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Completed

NCT Number: NCT02269540

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

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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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Imaging Centre, Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sertraline

Drug

selective serotonin reuptake inhibitor

Other names: Zoloft

Citalopram

Drug

selective serotonin reuptake inhibitor

Other names: Celexa

N-acetylcysteine (NAC)

Drug

natural health product

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

Primary outcomes

  1. MAO-A distribution volume with positron emission tomography

    Time frame: before and after treatment, 7 weeks on average between measures

    Treatment take 1 week for titration and 6 weeks at full dose=7weeks average

Secondary outcomes

  1. Hamilton Depression Rating Scale Score

    Time frame: before and after treatment, 7 weeks on average between measures

    Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

  2. Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)

    Time frame: before and after treatment, 7 weeks on average between measures

    Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

  3. Blood markers of monoamine oxidase-A fragment level and glutathione level

    Time frame: before and after treatment, 7 weeks on average between measures

    Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2014
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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