Tracking Response to Antidepressants in Advance of Investigational Trials

Last updated: March 23, 2023
Sponsor: Adams Clinical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Affective Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT04748276
TRAIT-MDD-107
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 diagnosticinterview and ≥ 14 HAM-D total score.
  • Participant is in good physical health and, in the opinion of the investigator, is asuitable candidate for treatment with an ADT.

Exclusion

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, orneurologic abnormality, which in the opinion of the investigator may impactparticipant safety or study results.
  • Participant has a history of any psychiatric condition other than MDD, which in theopinion of the investigator is primary, or any other psychiatric or neurologicdisorder or symptom that could pose undue risk to the participant or compromise thestudy.
  • Any participant who represents an acute suicidal risk in the opinion of theinvestigator.
  • Moderate or severe substance use disorder within 90 days prior to screen, according toDSM-5 criteria that in the opinion of the investigator could pose undue risk to theparticipant, or compromise the study.
  • Any condition that, in the opinion of the investigator, makes the participantunsuitable for the study.

Study Design

Total Participants: 400
Study Start date:
January 02, 2019
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

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