RECRUITING

Tracking Response to Antidepressants in Advance of Investigational Trials

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Conditions

Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tracking Response to Antidepressants in Advance of Investigational Trials

Quick Facts

Study Start:2019-01-02
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04748276

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has signed an ICF prior to any study-specific procedures being performed.
  2. * Participant is male or female of age ≥ 18 years old.
  3. * Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnostic interview and ≥ 14 HAM-D total score.
  4. * Participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an ADT.
  1. * Participant is pregnant, breast-feeding, or planning to become pregnant.
  2. * 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.
  3. * 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.
  4. * Any participant who represents an acute suicidal risk in the opinion of the investigator.
  5. * 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.
  6. * Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.

Contacts and Locations

Study Contact

Stephanie Ellickson, PhD
CONTACT
617-744-8542
sellickson@adamsclinical.com

Principal Investigator

Stephanie Ellickson, PhD
PRINCIPAL_INVESTIGATOR
Adams Clinical

Study Locations (Sites)

Adams Clinical
Watertown, Massachusetts, 02472
United States

Collaborators and Investigators

Sponsor: Adams Clinical

  • Stephanie Ellickson, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2019-01-02
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2019-01-02
Study Completion Date2023-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder