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

NCT04933630 | Completed FDA Drug

• 1 other identifier: TRAIT-MDD-401
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Outcomes (1)

• 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

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adams Clinical: lead

Study Sites (1)

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Jenicka Engler, PsyD

  Adams Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: June 1, 2021
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

US (1)