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

Study Overview
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Brief Summary
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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).

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)|Participants exiting the TRAIT study will have received a 90-day supply of their current protocol-approved antidepressant treatment (ADT) if clinically appropriate, prior to entering the TRAIT-RS study, in addition to a continuity of care letter to be given to their medical provider to facilitate a refill of that medication as desired. (See NCT04748276 for specific formulary and prescribing guidelines).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The number of participants who maintain ADT compliance as defined as ≥ 80% average monthly adherence during the observational period. |  | Up to 52 weeks |