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

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

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Stephanie Ellickson, PhD; Phone Number: 617-744-8542; Email: sellickson@adamsclinical.com

Study Locations

• United States
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Recruiting
      • Adams Clinical
      • Contact: Stephanie Ellickson, PhD; Phone Number: 617-744-8542; Email: sellickson@adamsclinical.com

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 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

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
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.	Up to 33 weeks

Secondary Outcome Measures

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.	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.	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.	Up to 33 weeks

Other Outcome Measures

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).	Up to 33 weeks
Presence of and change in sleep-related disturbance as assessed by the self-reported Insomnia Severity Index (ISI).	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).	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).	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.	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).	Up to 33 weeks

Collaborators and Investigators

• Sponsor: Adams Clinical
• Investigators: Principal Investigator: Stephanie Ellickson, PhD, Adams Clinical

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 7, 2021
• First Submitted That Met QC Criteria: February 7, 2021
• First Posted (Actual): February 10, 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-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