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

Early Phase 1
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Existing depression medication treatment
Registration Number
NCT02269540
Lead Sponsor
Centre for Addiction and Mental Health
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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Existing medication treatment & NACN-acetylcysteine (NAC)Existing depression medication treatment and n-acetylcysteine for seven weeks of treatment
Existing medication treatment & NACExisting depression medication treatmentExisting depression medication treatment and n-acetylcysteine for seven weeks of treatment
Sertraline and n-acetylcysteineN-acetylcysteine (NAC)Sertraline and n-acetylcysteine for seven weeks of treatment
Citalopram and n-acetylcysteineN-acetylcysteine (NAC)Citalopram and n-acetylcysteine for seven weeks of treatment
Sertraline and n-acetylcysteineSertralineSertraline and n-acetylcysteine for seven weeks of treatment
Citalopram and n-acetylcysteineCitalopramCitalopram and n-acetylcysteine for seven weeks of treatment
Primary Outcome Measures
NameTimeMethod
MAO-A distribution volume with positron emission tomographybefore and after treatment, 7 weeks on average between measures

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

Secondary Outcome Measures
NameTimeMethod
Hamilton Depression Rating Scale Scorebefore and after treatment, 7 weeks on average between measures

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

Blood markers of monoamine oxidase-A fragment level and glutathione levelbefore and after treatment, 7 weeks on average between measures

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

Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)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

Trial Locations

Locations (1)

Research Imaging Centre, Centre for Addiction and Mental Health

🇨🇦

Toronto, Ontario, Canada

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