Major Depressive DisorderEarly Phase 1NCT02269540
A New Treatment Approach for Major Depressive Disorder Based Upon Targeting Monoamine Oxidase A (MAO-A)
A Early Phase 1 study testing Sertraline, Citalopram and N-acetylcysteine (NAC) in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sertraline, Citalopram and N-acetylcysteine (NAC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Jul 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of current major depressive episode and major depressive disorder
- Hamilton Depression Rating Scale score of at least 20
Who cannot join
- 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
Show all 10Show fewer
- History of psychotic symptoms
- History of CNS medical illness
- Current substance use
- Test positive on pregnancy test (women)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Imaging Centre, Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
Official title: A New Biomarker-Based Approach Towards Developing Improved Treatment for Major Depressive Disorder (MDD) 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Sertraline, Citalopram, N-acetylcysteine (NAC), Existing depression medication treatment
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
selective serotonin reuptake inhibitor
CitalopramDrug
Also called Celexa
selective serotonin reuptake inhibitor
N-acetylcysteine (NAC)Drug
natural health product
Existing depression medication treatmentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Sertraline and n-acetylcysteine | Experimental | Sertraline and n-acetylcysteine for seven weeks of treatment Receives: Drug: Sertraline; Drug: N-acetylcysteine (NAC) |
| Citalopram and n-acetylcysteine | Experimental | Citalopram and n-acetylcysteine for seven weeks of treatment Receives: Drug: Citalopram; Drug: N-acetylcysteine (NAC) |
| Existing medication treatment & NAC | Experimental | Existing depression medication treatment and n-acetylcysteine for seven weeks of treatment Receives: Drug: N-acetylcysteine (NAC); Drug: Existing depression medication treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAO-A distribution volume with positron emission tomography
Treatment take 1 week for titration and 6 weeks at full dose=7weeks average
Measured: before and after treatment, 7 weeks on average between measures
Secondary outcomes (3)
Hamilton Depression Rating Scale Score
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Measured: before and after treatment, 7 weeks on average between measures
Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Measured: before and after treatment, 7 weeks on average between measures
Blood markers of monoamine oxidase-A fragment level and glutathione level
Treatment takes 1 week for titration and 6 weeks at full dose=7 weeks average
Measured: before and after treatment, 7 weeks on average between measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Meyer, Centre for Addiction and Mental Health
- Investigators
- Jeffrey H Meyer, MD, PhD, Principal investigator, Centre for Addiction and Mental Health; University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269540
- Sponsor's protocol ID
- 137/2013
- Status last verified
- May 2019
- First submitted
- 11 Aug 2014
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Biomarker-Based Approach Towards Developing Improved Treatment for Major Depressive Disorder (MDD) Based Upon Targeting Monoamine Oxidase A (MAO-A)
- ClinicalTrials.gov ID
- NCT02269540
- Acronym / sponsor ID
- 137/2013
- Conditions
- Major Depressive Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sertraline and n-acetylcysteine | Experimental | Drug: Sertraline, Drug: N-acetylcysteine (NAC)Sertraline and n-acetylcysteine for seven weeks of treatment |
| Citalopram and n-acetylcysteine | Experimental | Drug: Citalopram, Drug: N-acetylcysteine (NAC)Citalopram and n-acetylcysteine for seven weeks of treatment |
| Existing medication treatment & NAC | Experimental | Drug: N-acetylcysteine (NAC), Drug: Existing depression medication treatmentExisting depression medication treatment and n-acetylcysteine for seven weeks of treatment |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- DSM-IV diagnosis of current major depressive episode and major depressive disorder
- Hamilton Depression Rating Scale score of at least 20
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: Zoloftselective serotonin reuptake inhibitor | Drug | Sertraline and n-acetylcysteine |
| CitalopramAlso: Celexaselective serotonin reuptake inhibitor | Drug | Citalopram and n-acetylcysteine |
| N-acetylcysteine (NAC)natural health product | Drug | Citalopram and n-acetylcysteine, Existing medication treatment & NAC, Sertraline and n-acetylcysteine |
| Existing depression medication treatmentContinuation 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 | Drug | Existing medication treatment & NAC |
Primary outcome
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
3 secondary outcomes
Hamilton Depression Rating Scale Score
Time frame: before and after treatment, 7 weeks on average between measures
Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)
Time frame: before and after treatment, 7 weeks on average between measures
Blood markers of monoamine oxidase-A fragment level and glutathione level
Time frame: before and after treatment, 7 weeks on average between measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H Meyer, MD, PhD principal investigator
Centre for Addiction and Mental Health; University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sertraline, Citalopram and N-acetylcysteine (NAC) in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAO-A distribution volume with positron emission tomography (time frame: before and after treatment, 7 weeks on average between measures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.