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

NCT ID: NCT04933630

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-10-05

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adams Clinical

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenicka Engler, PsyD

Role: PRINCIPAL_INVESTIGATOR

Adams Clinical

Locations

Adams Clinical

Watertown, Massachusetts, United States

Countries

United States

Other Identifiers

TRAIT-MDD-401

Identifier Type: -

Identifier Source: org_study_id