Tracking how people with major depressive disorder respond to SSRIs and SNRIs before joining new tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TRAIT is an observational, open-label study that enrolls adults with MDD to observe responses to FDA-approved SSRIs and SNRIs. Participants must have a confirmed MDD diagnosis and a HAM-D score of 14 or higher. The study does not test new medications but tracks real-world responses to standard antidepressants in the context of potential participation in investigational trials. Eligibility requires informed consent, medical suitability, and absence of conditions that could affect safety or outcomes. The study is sponsored by Adams Clinical and conducted at their Watertown, MA site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Adams Clinical
  Watertown, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Stephanie Ellickson, PhD — Adams Clinical
• Study coordinator: Stephanie Ellickson, PhD
• Email: sellickson@adamsclinical.com
• Phone: 617-744-8542

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.