Major Depressive DisorderTRAITNCT04748276
Tracking Response to Antidepressants in Advance of Investigational Trials
An observational study of Major Depressive Disorder, run by Adams Clinical at 1 site in United States.
Trial summary
TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals meeting criteria for Major Depressive Disorder (MDD) and seeking enrollment in investigational trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who currently meet the Diagnostic and Statistical Manual - Version 5 (DSM-5) criteria for Major Depressive Disorder and are seeking enrollment in an industry-sponsored clinical trial of a second- or third-line antidepressant.
Who may be able to join
- Participant has signed an ICF prior to any study-specific procedures being performed.
- Participant is male or female of age ≥ 18 years old.
- Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnostic interview and ≥ 14 HAM-D total score.
- Participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an ADT.
Who cannot join
- Participant is pregnant, breast-feeding, or planning to become pregnant.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
- Participant has a history of any psychiatric condition other than MDD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
- Any participant who represents an acute suicidal risk in the opinion of the investigator.
- Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
- Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Adams Clinical
Watertown, Massachusetts, 02472
Stephanie Ellickson, PhD, 617-744-8542, sellickson@adamsclinical.com
About this study
TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals meeting criteria for Major Depressive Disorder (MDD) and seeking enrollment in investigational trials.
- Conditions
- Major Depressive Disorder
- Being tested
- FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)
- 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.
FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)Drug
Protocol-approved antidepressant treatments (ADT) will be prescribed in accordance with standard of care, whenever possible following dosing recommendations within the Study Formulary and Prescribing Guidelines (Sertraline 100 mg/day; Citalopram 20 mg/day; Escitalopram 10 mg/day; Fluoxetine 20 mg/day; Paroxetine 20 mg/day; Duloxetine 60 mg/day; Buproprion 300 mg/day; Desvenlafaxine 50 mg/day; Venlafaxine 150 mg/day). ADTs may be up or down-tapered as necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Inventory - 17 item (HAM-D) total score in response to a treatment cycle from Baseline/Day 0 to the end of a 6-week treatment cycle.
Measured: Up to 33 weeks
Secondary outcomes (3)
Failure to respond to 1, 2, or 3+ ADT treatment cycles, as defined as < 25% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.
Measured: Up to 33 weeks
Partial response to 1, 2, or 3+ ADT treatment cycles, as defined as ≥ 25% to < 50% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.
Measured: Up to 33 weeks
Total number of treatment cycles required to reach ADT response, as defined as ≥ 50% reduction in HAM-D score from Baseline/Day 0 to Day 42 of each treatment cycle.
Measured: Up to 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start2 Jan 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adams Clinical
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Stephanie Ellickson, PhD, Principal investigator, Adams Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748276
- Sponsor's protocol ID
- TRAIT-MDD-107
- Acronym
- TRAIT
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Response to Antidepressants in Advance of Investigational Trials
- ClinicalTrials.gov ID
- NCT04748276
- Acronym / sponsor ID
- TRAIT / TRAIT-MDD-107
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Adams ClinicalResearch network
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 2021 (actual)
- 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.
TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals meeting criteria for Major Depressive Disorder (MDD) and seeking enrollment in investigational trials.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who currently meet the Diagnostic and Statistical Manual - Version 5 (DSM-5) criteria for Major Depressive Disorder and are seeking enrollment in an industry-sponsored clinical trial of a second- or third-line antidepressant.
Key inclusion criteria (4 listed)
- Participant has signed an ICF prior to any study-specific procedures being performed.
- Participant is male or female of age ≥ 18 years old.
- Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnostic interview and ≥ 14 HAM-D total score.
- Participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an ADT.
Key exclusion criteria (6 listed)
- Participant is pregnant, breast-feeding, or planning to become pregnant.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
- Participant has a history of any psychiatric condition other than MDD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
- Any participant who represents an acute suicidal risk in the opinion of the investigator.
- Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
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 |
|---|---|---|
| FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)Protocol-approved antidepressant treatments (ADT) will be prescribed in accordance with standard of care, whenever possible following dosing recommendations within the Study Formulary and Prescribing Guidelines (Sertraline 100 mg/day; Citalopram 20 mg/day; Escitalopram 10 mg/day; Fluoxetine 20 mg/day; Paroxetine 20 mg/day; Duloxetine 60 mg/day; Buproprion 300 mg/day; Desvenlafaxine 50 mg/day; Venlafaxine 150 mg/day). ADTs may be up or down-tapered as necessary. | Drug | – |
Primary outcome
Change in Hamilton Depression Inventory - 17 item (HAM-D) total score in response to a treatment cycle from Baseline/Day 0 to the end of a 6-week treatment cycle.
Time frame: Up to 33 weeks
3 secondary outcomes
Failure to respond to 1, 2, or 3+ ADT treatment cycles, as defined as < 25% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.
Time frame: Up to 33 weeks
Partial response to 1, 2, or 3+ ADT treatment cycles, as defined as ≥ 25% to < 50% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.
Time frame: Up to 33 weeks
Total number of treatment cycles required to reach ADT response, as defined as ≥ 50% reduction in HAM-D score from Baseline/Day 0 to Day 42 of each treatment cycle.
Time frame: Up to 33 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Stephanie Ellickson, PhD principal investigator
Adams Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Adams Clinical at 1 site in United States.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Ellickson, PhD (617-744-8542, sellickson@adamsclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Inventory - 17 item (HAM-D) total score in response to a treatment cycle from Baseline/Day 0 to the end of a 6-week treatment cycle. (time frame: Up to 33 weeks). 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 27 Oct 2026.