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

Sponsor
Adams Clinical (Other)
Overall Status
Recruiting
CT.gov ID
NCT04933630
Collaborator
(none)
400
Enrollment
1
Location
31
Anticipated Duration (Months)
12.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Tracking Response to Antidepressants in Advance of Investigational Trials, Relapse Study
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

  2. 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

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adams Clinical Watertown Massachusetts United States 02472

Sponsors and Collaborators

  • Adams Clinical

Investigators

  • Principal Investigator: Jenicka Engler, PsyD, Adams Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adams Clinical
ClinicalTrials.gov Identifier:
NCT04933630
Other Study ID Numbers:
  • TRAIT-MDD-401
First Posted:
Jun 22, 2021
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors

Study Results

No Results Posted as of Jun 22, 2021