Tracking Response to Antidepressants in Advance of Investigational Trials, Relapse Study

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT04933630
• Lead Sponsor: Adams Clinical

Brief Summary

TRAIT-RS is an observational study to evaluate ongoing treatment response stability to standard of care antidepressant treatments (ADTs) among individuals who met criteria for Major Depressive Disorder (MDD) and completed the Tracking Response to Antidepressants in Advance of Investigational Trials (TRAIT) study (NCT04748276).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Primary Completion: 2022-10-05
• Study Completion: 2022-10-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Participant has completed the TRAIT study and, in the opinion of the investigator, would benefit from ongoing depression monitoring and/or ADT treatment.
• Participant has signed an ICF prior to any study-specific procedures being performed.
• Participant is male or female of age ≥ 18 years.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stability of treatment response as defined as change in self-report PHQ-9 total scores during the observational period from Baseline/Day 0 to End of Study (EOS)/Day 365.	Up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
The number of participants who maintain ADT compliance as defined as ≥ 80% average monthly adherence during the observational period.	Up to 52 weeks
The number of participants who meet MDD relapse criteria as defined as the higher of a) PHQ-9 score ≥ 10, or b) ≥ 50% increase in PHQ-9 score from Baseline/Day 0, and verified by clinician-rated assessment as indicated by a HAM-D score ≥ 14 and CGI ≥ 4.	Up to 52 weeks

Trial Locations

Locations (1)

Adams Clinical; 🇺🇸 Watertown, Massachusetts, United States