Tracking Response to Antidepressants in Advance of Investigational Trials

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    400
  • sponsor
    Adams Clinical
Updated on 19 March 2021

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.

Details
Condition Major depression, Endogenous depression, major depressive disorder, major depressive disorders
Treatment FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)
Clinical Study IdentifierNCT04748276
SponsorAdams Clinical
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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