Tracking Response to Antidepressants in Advance of Investigational Trials (TRAIT)

March 23, 2023 updated by: Adams Clinical
TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals meeting criteria for Major Depressive Disorder (MDD) and seeking enrollment in investigational trials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 currently meet the Diagnostic and Statistical Manual - Version 5 (DSM-5) criteria for Major Depressive Disorder and are seeking enrollment in an industry-sponsored clinical trial of a second- or third-line antidepressant.

Description

Inclusion Criteria:

  • Participant has signed an ICF prior to any study-specific procedures being performed.
  • Participant is male or female of age ≥ 18 years old.
  • Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnostic interview and ≥ 14 HAM-D total score.
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Hamilton Depression Inventory - 17 item (HAM-D) total score in response to a treatment cycle from Baseline/Day 0 to the end of a 6-week treatment cycle.
Time Frame: Up to 33 weeks
Up to 33 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Failure to respond to 1, 2, or 3+ ADT treatment cycles, as defined as < 25% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.
Time Frame: Up to 33 weeks
Up to 33 weeks
Partial response to 1, 2, or 3+ ADT treatment cycles, as defined as ≥ 25% to < 50% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.
Time Frame: Up to 33 weeks
Up to 33 weeks
Total number of treatment cycles required to reach ADT response, as defined as ≥ 50% reduction in HAM-D score from Baseline/Day 0 to Day 42 of each treatment cycle.
Time Frame: Up to 33 weeks
Up to 33 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Presence of and change in anxiety symptoms as assessed by the MDD with Anxious Distress subscale of the Mini-International Neuropsychiatric Inventory (MINI), and self-report on the Beck Anxiety Inventory (BAI).
Time Frame: Up to 33 weeks
Up to 33 weeks
Presence of and change in sleep-related disturbance as assessed by the self-reported Insomnia Severity Index (ISI).
Time Frame: Up to 33 weeks
Up to 33 weeks
Presence of and change in anger symptoms as assessed by the self-reported Massachusetts General Hospital Anger Attacks Questionnaire (MGH AAQ), and the self-reported Concise Associated Symptoms Tracking Scale (CAST-SR).
Time Frame: Up to 33 weeks
Up to 33 weeks
Presence of and change in depression-/treatment- related sexual dysfunction as assessed by the self-reported Change in Sexual Functioning Questionnaire (CSFQ).
Time Frame: Up to 33 weeks
Up to 33 weeks
Presence of and change in functional impairment as assessed by the Sheehan Disability Scale, Inventory of Depressive Symptomology, Short Form Survey Instruments, Patient Global Impressions, and the Clinical Global Impression scale.
Time Frame: Up to 33 weeks
Up to 33 weeks
Presence of and change in pain conditions as assessed by the self-reported Brief Pain Inventory, Short Form (BPI-SF) and Visual Analog Scale - Pain (VAS-PAIN).
Time Frame: Up to 33 weeks
Up to 33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adams Clinical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephanie Ellickson, PhD, Adams Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRAIT-MDD-107

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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