Tracking Response to Antidepressants in Advance of Investigational Trials

Major Depressive Disorder Clinical Trial

— TRAIT  

Official title:

Tracking Response to Antidepressants in Advance of Investigational Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748276
• Other study ID #: TRAIT-MDD-107
• Status: Recruiting
• Start date: January 2, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Adams Clinical
• Contact: Stephanie Ellickson, PhD
• Phone: 617-744-8542
• Email: sellickson[@]adamsclinical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Adams Clinical	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Adams Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Presence of and change in sleep-related disturbance as assessed by the self-reported Insomnia Severity Index (ISI).		Up to 33 weeks
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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