Recruiting

Antidepressants

Sponsor:

Adams Clinical

Code:

NCT04748276

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT04748276

Start date

Jan 2, 2019

Status verified date

Mar, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Stephanie Ellickson, PhD

617-744-8542sellickson@adamsclinical.com

Locations

Adams Clinical

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Stephanie Ellickson, PhD

617-744-8542sellickson@adamsclinical.com

More Information

Sponsor

Adams Clinical

Last update posted

Mar 27, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Adams Clinical on 2023-03-27.