Tracking Response to Antidepressants in Advance of Investigational Trials

NCT04748276 | Unknown FDA Drug

• 1 other identifier: TRAIT-MDD-107
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (6)

• 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

Interventions

FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) DRUG

Protocol-approved antidepressant treatments (ADT) will be prescribed in accordance with standard of care, whenever possible following dosing recommendations within the Study Formulary and Prescribing Guidelines (Sertraline 100 mg/day; Citalopram 20 mg/day; Escitalopram 10 mg/day; Fluoxetine 20 mg/day; Paroxetine 20 mg/day; Duloxetine 60 mg/day; Buproprion 300 mg/day; Desvenlafaxine 50 mg/day; Venlafaxine 150 mg/day). ADTs may be up or down-tapered as necessary.

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 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.

You may qualify if:

• 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.

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

RECRUITING

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

• Stephanie Ellickson, PhD

  Adams Clinical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Ellickson, PhD

CONTACT

617-744-8542; sellickson@adamsclinical.com

Study Design

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

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 10, 2021
• Study Start: January 2, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

US (1)