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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) | Drug | 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). |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of non-relapsing participants who elect to continue ADT treatment when incurring medication costs following an initial no-cost 90-day supply. | Up to 52 weeks |
Inclusion Criteria:
Exclusion Criteria:
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Adults who previously met the Diagnostic and Statistical Manual - Version 5 (DSM-5) criteria for Major Depressive Disorder (MDD), sought enrollment in an industry-sponsored antidepressant trial, achieved MDD symptom remission in the TRAIT study, and, in the opinion of the investigator, would benefit from ongoing depression monitoring and/or ADT treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Jenicka Engler, PsyD | Adams Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adams Clinical | Watertown | Massachusetts | 02472 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Up to 52 weeks |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |