TRIAGE: Triage Survey for CNS Research Eligibility

Sponsor

Adams Clinical (Other)

Overall Status

Recruiting

CT.gov ID

NCT05800925

Collaborator

(none)

2,000

Enrollment

Location

48.3

Anticipated Duration (Months)

41.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TRIAGE is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored CNS clinical trials.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Borderline Personality Disorder Alzheimer Disease	Other: Survey

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Triage Survey for CNS Research Eligibility

Actual Study Start Date :

Dec 21, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

The proportion of participants who are eligible for industry-sponsored clinical trials, as defined as those who go on to screen for a study [Up to 52 weeks]

Secondary Outcome Measures

The proportion of participants who enroll in industry-sponsored clinical trials [Up to 52 weeks]
The prevalence of disqualifying comorbid conditions that prevent screening or enrollment in industry-sponsored clinical trials [Up to 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
Participant is at least 18 years old.

Exclusion Criteria:

Participant is pregnant, breast-feeding, or planning to become pregnant.
History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on C-SSRS questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
Any condition that in the investigator's opinion makes a participant unsuitable for the study.
Currently employed by Adams Clinical or a first-degree relative of an employee.