Tracking Response to Antidepressants in Advance of Investigational Trials, Relapse Study (TRAIT-RS)

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Adams Clinical
• Investigators: Principal Investigator: Jenicka Engler, PsyD, Adams Clinical

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin Receptor Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine; Serotonin; Serotonin Uptake Inhibitors
• Other Study ID Numbers: TRAIT-MDD-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No